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Yahoo
7 days ago
- Business
- Yahoo
KalVista Pharmaceuticals Medical Congress Presentations Highlight Potential of Sebetralstat to Redefine Hereditary Angioedema Management
–Attack progression halted in median 19.8 minutes after treatment with sebetralstat in both KONFIDENT and KONFIDENT-S trials– –Sebetralstat data demonstrated rapid relief and resolution of severe HAE attacks– CAMBRIDGE, Mass. & SALISBURY, England, June 02, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced new sebetralstat findings related to time to end of progression of hereditary angioedema (HAE) attacks, and the effectiveness of treatment of attacks considered the most debilitating by patients, mucosal attacks, and attacks that have progressed in severity after a treatment delay. These data were presented at two congresses taking place concurrently: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida, from May 29–June 1, 2025. Time to End of Progression of Hereditary Angioedema Attacks Treated with Sebetralstat was presented by William Lumry, M.D., Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School in Dallas and Director at Allergy and Asthma Research Associates, Dallas, Texas, United States. Time to end of attack progression (n=1591 attacks) in KONFIDENT-S: median 19.8 minutes Results from the open-label extension (KONFIDENT-S) aligned closely with the pivotal phase 3 trial, KONFIDENT, reinforcing the rapid effect of sebetralstat after absorption "Stopping the progression of an HAE attack as early as possible is paramount to mitigating its impact on patients," said Dr. Lumry. "In both the KONFIDENT and KONFIDENT-S studies, sebetralstat halted attack progression in a median time of 19.8 minutes. As prior data have demonstrated near-complete plasma kallikrein inhibition 15 minutes after treatment, this analysis reveals that attacks are halted minutes after absorption. The consistency of findings across the KONFIDENT and KONFIDENT-S trials underscores the potential of sebetralstat as an effective and rapid-acting on-demand treatment for HAE attacks." Effectiveness of sebetralstat for the on-demand treatment of mucosal hereditary angioedema attacks: interim analysis from KONFIDENT-S was presented by Henriette Farkas, M.D., PhD, DSc, Professor of Allergology and Clinical Immunology at Semmelweis University and Head of the Hungarian Angioedema Center of Reference and Excellence, Budapest, Hungary. Patients were able to self-administer sebetralstat quickly, with a median time to treatment of 20 minutes for abdominal attacks and 11.5 minutes for laryngeal attacks The median time to beginning of symptom relief was 1.3 hours for both abdominal and laryngeal attacks Of attacks reaching symptom relief within 12 hours, 96% did so before or without the need for an additional sebetralstat administration Sebetralstat was well-tolerated, even in laryngeal attacks, with no reported difficulties swallowing the oral tablet "Mucosal HAE attacks, particularly those affecting the larynx, are a significant concern for patients and clinicians due to the risk of rapid progression and severe consequences, including the possibility of asphyxiation if left untreated," said Dr. Farkas. "These interim data from KONFIDENT-S demonstrate that sebetralstat provided rapid relief and resolution of both abdominal and laryngeal attacks with a favorable safety profile. Patients were able to self-administer sebetralstat very early in the course of an attack, when most attacks were still mild or moderate in severity." Effectiveness of Sebetralstat for Severe or Very Severe Hereditary Angioedema Attacks in KONFIDENT-S was presented by H. Henry Li, M.D., Director of Immunology at the Institute for Asthma and Allergy, Wheaton, Maryland, United States. Sebetralstat was used to treat 76 attacks that had progressed to severe or very severe after a median of 2.16 hours from attack onset, demonstrating its utility in more advanced stages of HAE attacks The median time to beginning of symptom relief for these attacks was 1.36 hours, with reduction in attack severity and substantial reduction of symptom burden in a median of 1.77 hours and 9.15 hours, respectively "When attacks are not treated early in accordance with guidelines, they can escalate and become severe," said Dr. Li. "We conducted this analysis of KONFIDENT-S to assess the utility of sebetralstat in more advanced stages of attacks that were associated with delayed treatment. Sebetralstat delivered symptom relief in a median time of 1.36 hours, reinforcing its potential as an on-demand treatment for challenging attack scenarios." "These new data underscore the potential of sebetralstat to fundamentally change HAE attack management," stated Paul Audhya, M.D., MBA, Chief Medical Officer of KalVista. "Even in real-world, high-stakes scenarios—be it mucosal attacks or severe attacks due to delayed treatment—sebetralstat consistently delivered rapid and reliable relief. The uniformity of these results, paired with an oral tablet formulation, solidifies our belief that sebetralstat can empower patients to act swiftly and recover quickly. We remain committed to bringing this innovative therapy to the HAE community as quickly as possible." Links to all presentations can be found on the KalVista website under Publications. About SebetralstatSebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. About Hereditary AngioedemaHereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. Forward-Looking StatementsThis press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. View source version on Contacts Ryan BakerHead, Investor Relations(617) Molly CameronDirector, Corporate Communications(978)
Business Wire
7 days ago
- Health
- Business Wire
KalVista Pharmaceuticals Medical Congress Presentations Highlight Potential of Sebetralstat to Redefine Hereditary Angioedema Management
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced new sebetralstat findings related to time to end of progression of hereditary angioedema (HAE) attacks, and the effectiveness of treatment of attacks considered the most debilitating by patients, mucosal attacks, and attacks that have progressed in severity after a treatment delay. These data were presented at two congresses taking place concurrently: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida, from May 29–June 1, 2025. Time to End of Progression of Hereditary Angioedema Attacks Treated with Sebetralstat was presented by William Lumry, M.D., Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School in Dallas and Director at Allergy and Asthma Research Associates, Dallas, Texas, United States. Time to end of attack progression (n=1591 attacks) in KONFIDENT-S: median 19.8 minutes Results from the open-label extension (KONFIDENT-S) aligned closely with the pivotal phase 3 trial, KONFIDENT, reinforcing the rapid effect of sebetralstat after absorption 'Stopping the progression of an HAE attack as early as possible is paramount to mitigating its impact on patients,' said Dr. Lumry. 'In both the KONFIDENT and KONFIDENT-S studies, sebetralstat halted attack progression in a median time of 19.8 minutes. As prior data have demonstrated near-complete plasma kallikrein inhibition 15 minutes after treatment, this analysis reveals that attacks are halted minutes after absorption. The consistency of findings across the KONFIDENT and KONFIDENT-S trials underscores the potential of sebetralstat as an effective and rapid-acting on-demand treatment for HAE attacks.' Effectiveness of sebetralstat for the on-demand treatment of mucosal hereditary angioedema attacks: interim analysis from KONFIDENT-S was presented by Henriette Farkas, M.D., PhD, DSc, Professor of Allergology and Clinical Immunology at Semmelweis University and Head of the Hungarian Angioedema Center of Reference and Excellence, Budapest, Hungary. Patients were able to self-administer sebetralstat quickly, with a median time to treatment of 20 minutes for abdominal attacks and 11.5 minutes for laryngeal attacks The median time to beginning of symptom relief was 1.3 hours for both abdominal and laryngeal attacks Of attacks reaching symptom relief within 12 hours, 96% did so before or without the need for an additional sebetralstat administration Sebetralstat was well-tolerated, even in laryngeal attacks, with no reported difficulties swallowing the oral tablet 'Mucosal HAE attacks, particularly those affecting the larynx, are a significant concern for patients and clinicians due to the risk of rapid progression and severe consequences, including the possibility of asphyxiation if left untreated,' said Dr. Farkas. 'These interim data from KONFIDENT-S demonstrate that sebetralstat provided rapid relief and resolution of both abdominal and laryngeal attacks with a favorable safety profile. Patients were able to self-administer sebetralstat very early in the course of an attack, when most attacks were still mild or moderate in severity.' Effectiveness of Sebetralstat for Severe or Very Severe Hereditary Angioedema Attacks in KONFIDENT-S was presented by H. Henry Li, M.D., Director of Immunology at the Institute for Asthma and Allergy, Wheaton, Maryland, United States. Sebetralstat was used to treat 76 attacks that had progressed to severe or very severe after a median of 2.16 hours from attack onset, demonstrating its utility in more advanced stages of HAE attacks The median time to beginning of symptom relief for these attacks was 1.36 hours, with reduction in attack severity and substantial reduction of symptom burden in a median of 1.77 hours and 9.15 hours, respectively 'When attacks are not treated early in accordance with guidelines, they can escalate and become severe,' said Dr. Li. 'We conducted this analysis of KONFIDENT-S to assess the utility of sebetralstat in more advanced stages of attacks that were associated with delayed treatment. Sebetralstat delivered symptom relief in a median time of 1.36 hours, reinforcing its potential as an on-demand treatment for challenging attack scenarios.' 'These new data underscore the potential of sebetralstat to fundamentally change HAE attack management," stated Paul Audhya, M.D., MBA, Chief Medical Officer of KalVista. "Even in real-world, high-stakes scenarios—be it mucosal attacks or severe attacks due to delayed treatment—sebetralstat consistently delivered rapid and reliable relief. The uniformity of these results, paired with an oral tablet formulation, solidifies our belief that sebetralstat can empower patients to act swiftly and recover quickly. We remain committed to bringing this innovative therapy to the HAE community as quickly as possible.' Links to all presentations can be found on the KalVista website under Publications. About Sebetralstat Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Yahoo
22-05-2025
- Health
- Yahoo
KalVista Pharmaceuticals to Present New Sebetralstat Data With 10 Abstracts Accepted at Upcoming Medical Meetings
CAMBRIDGE, Mass. & SALISBURY, England, May 22, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that it will present new sebetralstat data at two upcoming congresses taking place concurrently from May 29–June 1, 2025: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida. The presentations will include new findings on the potential of sebetralstat to rapidly relieve symptoms and halt progression of hereditary angioedema (HAE) attacks, including mucosal and severe cases, underscoring the importance of early intervention and the role of an oral on-demand treatment option. Details of the presentations are as follows: C1-inhibitor Deficiency & Angioedema Workshop The following poster presentations will take place during Poster Session I on Friday, May 30, from 3:45–5:30 pm CEST (9:45–11:30 am ET): In their own words, patient perspectives on time to feeling in control of an HAE attack (P-18): Doug Jones, Anna Valerieva, Mar Guilarte, Neil Malloy, Sally van Kooten, Markus Heckmann, Markus Magerl. Time to end of progression of hereditary angioedema attacks treated with sebetralstat (P-25): William R. Lumry, John Anderson, Jonathan A. Bernstein, Mauro Cancian, Danny M. Cohn, Henriette Farkas, Henry Li, James Hao, Michael Smith, Paolo Bajcic, Paul Audhya, Markus Magerl. Impact of injectable HAE on-demand treatments on health-related quality of life: a patient and caregiver interview study (P-29): Patrick Yong, Aleena Banerji, Paula Busse, Timothy Craig, Sorena Kiani-Alikhan, Rebekah Hall, Siu Hing Lo, Caleb Dixon, Paul Audhya, Alice Wang, Tomaz Garcez. The following oral presentation will take place during Scientific Session III on Saturday, May 31, from 2:30–2:45 pm CEST (8:30–8:45 am ET): Effectiveness of sebetralstat for the on-demand treatment of mucosal hereditary angioedema attacks: interim analysis from KONFIDENT-S (O-29): Jonathan A. Bernstein, Emel Aygören-Pürsün, Vesna Grivcheva-Panovska, Inmaculada Martinez-Saguer, Danny M. Cohn, William R. Lumry, Marc A. Riedl, Andrea Zanichelli, Laurence Bouillet, Ya-Hsiu Chuang, Michael D. Smith, Christopher M. Yea, Paul K. Audhya, Henriette Farkas. The following oral presentation will take place during Scientific Session V on Saturday, May 31, from 3:15–3:30 pm CEST (9:15–9:30 am ET): Anxiety associated with hereditary angioedema attacks: results from the phase 3 KONFIDENT trial of oral sebetralstat (O-32): Timothy J. Craig, Emel Aygören-Pürsün, Jonathan A. Bernstein, Paula J. Busse, Teresa Caballero, Danny M. Cohn, Mar Guilarte, Henriette Farkas, Douglas H. Jones, Sorena Kiani-Alikhan, Michael E. Manning, Marcus Maurer, Marc A. Riedl, Sinisa Savic, H. James Wedner, Patrick F. K. Yong, Andrea Zanichelli, Erik Hansen, James Hao, Michael D. Smith, Christopher M. Yea, Paul K. Audhya, William R. Lumry. The following poster presentation will take place during Poster Session II on Saturday, May 31, from 4:15–5:45 pm CEST (10:15–11:45 am ET): Survey results from Italy, the US, UK, and France: Anxiety in patients using injectable on-demand treatments for hereditary angioedema attacks (P-32): Mauro Cancian, Alexis Bocquet, Paula J. Busse, Timothy Craig, Tariq El-Shanawany, Tomaz Garcez, Padmalal Gurugama, Rashmi Jain, Sorena Kiani-Alikhan, Maeve O'Connor, Cristine Radojicic, Sinisa Savic, Paola Triggianese, H. James Wedner, Patrick Yong, Andrea Zanichelli, Vibha Desai, Julie Ulloa, Sherry Danese, Paul K. Audhya, Sandra Christiansen. KalVista is also sponsoring a pre-workshop symposium for healthcare professionals on Thursday, May 29, from 1:00–2:00 pm CEST (7:00–8:00 am ET) in the Magnolia room, titled "Interplay Between On-Demand Treatment Guidelines and Clinical Trials in HAE." Chaired by Dr. William Lumry, Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School and Medical Director of AARA Research Center, this symposium will highlight insights from Dr. Mauro Cancian (University Hospital of Padova, Italy) and Dr. Danny Cohn (University of Amsterdam, Netherlands), addressing the evolution of on-demand treatment guidelines in HAE, real-world challenges in guideline adherence, and advancements in clinical trial designs to support guideline adherence. EAC The following poster presentations will take place on Saturday, May 31, from 9:45–11:00 am ET: Effectiveness of Sebetralstat for Severe or Very Severe Hereditary Angioedema Attacks in KONFIDENT-S: Henry Li, William R. Lumry, Michael E. Manning, Marc A. Riedl, James Wedner, James Hao, Michael D. Smith, Paul K. Audhya, Jonathan A. Bernstein. On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat in Older Adults: Interim Analysis from KONFIDENT-S: Daniel F. Soteres, Alan P. Baptist, Jonathan A. Bernstein, Timothy Craig, William R. Lumry, James Hao, Michael D. Smith, Paolo Bajcic, Paul K. Audhya, Marc A. Riedl. Time to End of Progression of Hereditary Angioedema Attacks Treated with Sebetralstat: Daniel F. Soteres, William R. Lumry, John Anderson, Jonathan A. Bernstein, Mauro Cancian, Danny M. Cohn, Henriette Farkas, Henry Li, James Hao, Michael D. Smith, Paolo Bajcic, Paul K. Audhya, Markus Magerl. Long-Term Prophylaxis Compliance and Healthcare Resource Utilization in Hereditary Angioedema: A Claims Database Analysis: Raffi Tachdjian, Daniel F. Soteres, Maeve O'Connor, Chirag Maheshwari, Alice Wang, Paul K. Audhya, Timothy Craig. Links to all presentations can be found on the KalVista website under Publications. About SebetralstatSebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. About Hereditary AngioedemaHereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. Forward-Looking StatementsThis press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. View source version on Contacts Ryan BakerHead, Investor Relations(617) Molly CameronDirector, Corporate Communications(857) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
03-03-2025
- Health
- Yahoo
KalVista Pharmaceuticals Shares Latest Sebetralstat Findings at the American Academy of Allergy, Asthma & Immunology 2025 Annual Meeting
–Sebetralstat enabled prompt treatment of laryngeal HAE attacks with median time of 1 hour and 16 minutes to onset of symptom relief– –Pooled data analysis showed adolescents treated with sebetralstat in median 4 minutes compared to over 3 hours in surveys – CAMBRIDGE, Mass. & SALISBURY, England, March 03, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced the presentation of novel sebetralstat data related to laryngeal hereditary angioedema (HAE) attacks and adolescents with HAE at the American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) 2025 Joint Congress taking place in San Diego, CA from February 28–March 3, 2025. "The growing body of data from the KONFIDENT-S study consistently demonstrate that sebetralstat enabled early treatment and fast symptom relief from HAE attacks, regardless of age, attack location, or severity," said Ben Palleiko, CEO of KalVista. "This is especially critical for vulnerable populations, such as those experiencing laryngeal attacks or adolescents whose only approved options are injectable on-demand treatments. Sebetralstat, if approved, would be the first oral on-demand treatment for HAE attacks, with the potential to address some of the most significant unmet needs in HAE and become the foundational therapy for HAE management." Effectiveness of Sebetralstat for the On-demand Treatment of Laryngeal Hereditary Angioedema Attacks: Interim Analysis from KONFIDENT-S was presented by Jonathan Bernstein, MD, FAAAAI, Professor of Clinical Medicine in the Department of Internal Medicine, Division of Allergy and Immunology at the University of Cincinnati College of Medicine; Partner at Bernstein Allergy Group and Clinical Research Center. 32 laryngeal attacks were treated with sebetralstat (September 14, 2024 cutoff) Median time to treatment with sebetralstat: 11.5 minutes after attack onset Median time to beginning of symptom relief: 1.27 hours 96% of those achieving beginning of symptom relief within 12 hours did so with a single dose No reports of difficulty swallowing film-coated tablet "Laryngeal attacks are often unpredictable and can progress rapidly, potentially leading to asphyxiation," said Dr. Bernstein. "Any attack involving the larynx must be considered a medical emergency and treated as quickly as possible after onset before symptoms worsen. Despite this, recent U.S. survey data showed the mean time to treatment for laryngeal attacks with injectable on-demand therapies was 2.5 hours. Patients in the KONFIDENT-S study treated their attacks with sebetralstat, with a median time to treatment of just under 12 minutes, followed by symptom relief with a median time of 1 hour and 16 minutes. These results show that in the time it takes many patients to decide whether to treat, prepare and administer an injectable on-demand treatment, most patients in KONFIDENT-S were already experiencing symptom relief. If approved, sebetralstat could represent a therapeutic advance over injectables." On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat In Adolescents: Pooled Analysis From KONFIDENT And KONFIDENT-S was presented by Professor Danny Cohn, Head of the HAE clinic at Amsterdam University Medical Center (UMC), University of Amsterdam, Netherlands. 149 attacks were treated with sebetralstat across KONFIDENT/KONFIDENT-S (September 14, 2024 cutoff) Median time from attack onset to treatment: 4 minutes Safety and efficacy consistent with adults; no serious adverse events or adverse events leading to discontinuation "Adolescents face considerable challenges in treating their HAE attacks, with substantially longer delays to treatment than adults. This challenge is compounded in the U.S., where the only approved treatments options require either intravenous administration or subcutaneous administration by an HCP," said Dr. Cohn. "The pooled data from the KONFIDENT and KONFIDENT-S studies show that adolescents administered sebetralstat in a median of 4 minutes after attack onset, which compares favorably to a median of 3 hours and mean of 5.2 hours based on international survey data that was presented at AAAAI by Dr. Paula Busse titled, 'Burden of Injectable On-Demand Treatment for Hereditary Angioedema Attacks in Adolescents'. Importantly, the safety and effectiveness of sebetralstat were consistent with what was observed in adults. The portability and ease of administration of sebetralstat, along with the elimination of injection-site reactions and associated anxiety, has the potential to bring transformative change to this underserved patient population." Links to all posters and presentations shared at AAAAI can be found on the KalVista website under Publications. About Sebetralstat Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. View source version on Contacts Ryan BakerHead, Investor Relations(617) Molly CameronDirector, Corporate Communications(978) Sign in to access your portfolio
Yahoo
10-02-2025
- Health
- Yahoo
KalVista Pharmaceuticals Presents New Sebetralstat Data at the Western Society of Allergy, Asthma & Immunology 2025 Annual Meeting
– Claims data show 40% of patients on long-term prophylaxis have gaps in prescription refills, leading to greater on-demand use and higher rate of LTP discontinuation- -Data from KONFIDENT-S show patients on LTP average 1.7 HAE attacks per month and symptom relief for treated attacks in median 1.3 hours - –Results confirm sebetralstat effective for on-demand treatment of attacks regardless of type of LTP therapy used, including an all-oral regimen– CAMBRIDGE, Mass. & SALISBURY, England, February 10, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the presentation of novel data related to long-term prophylaxis and sebetralstat at the Western Society of Allergy, Asthma & Immunology (WSAAI) 2025 Annual Meeting taking place in Waimea, HI from February 9-13, 2025. Raffi Tachdjian, MD, MPH, Associate Clinical Professor of Medicine and Pediatrics in the Division of Allergy and Clinical Immunology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), presented data on the Impact of Long-Term Prophylaxis (LTP) Adherence in Hereditary Angioedema Patients: Results of a Claims Database Analysis. According to a US commercial claims analysis, nearly 40% of HAE patients who initiated LTP had substantial refill gaps in claims over 12 months, with more than half of those discontinuing LTP. For patients with substantial refill gaps, which increase the likelihood of non-adherence, on-demand claims remained unchanged before and after one year of starting LTP. "Despite guidelines emphasizing regular assessment of patients using LTP to confirm efficacy and safety of their therapy, these data suggest many patients experience substantial lapses in refilling their LTP, which may reflect non-adherence," said Dr. Tachdjian. "We saw no decrease in on-demand claims for patients with LTP refill gaps. These findings are important as most HAE patients in the US now receive LTP, and a greater focus on monitoring appears warranted, as LTP effectiveness is not a given. These data may also help to explain why on-demand treatment volumes in HAE have remained steady despite the advent of several effective subcutaneous and oral LTP options since 2017." Marc A. Riedl, MD, Professor of Medicine and Clinical Director, US Hereditary Angioedema Association Center at the University of California, San Diego, presented data on the Safety and Effectiveness of Sebetralstat in Patients with Hereditary Angioedema Receiving Long-Term Prophylaxis: Interim Analysis from the KONFIDENT-S Open-Label Study. Participants receiving LTP treated 382 attacks with sebetralstat (mean 1.7 attacks per month), of which more than half involved the abdomen and/or larynx. Sebetralstat enabled early treatment (median 6 minutes) and early symptom relief (median 1.3 hours), and was well-tolerated, regardless of LTP mechanism of action or route of administration. "Treatment guidelines recommend that patients with HAE should consider treating all attacks regardless of LTP use and should treat attacks as early as possible," noted Dr. Riedl. "These interim results suggest that, if approved, sebetralstat could be a safe and effective oral on-demand treatment for breakthrough attacks, regardless of severity, location, or type of LTP used." Michael E. Manning, MD, allergist-immunologist at Allergy, Asthma and Immunology Associates, Ltd., Scottsdale, Arizona and Past President of WSAAI, presented Sebetralstat for the Treatment of HAE Attacks in Patients Receiving Berotralstat: Interim Analysis from the KONFIDENT-S Open-Label Study. Participants receiving berotralstat treated 178 attacks with sebetralstat (mean 1.8 attacks per month). Sebetralstat enabled early treatment (median 20 minutes), early symptom relief (median 1.3 hours), and was well-tolerated with no increase in gastrointestinal side effects. "In general, patients prefer oral treatments over injectables, underscoring the strong interest in oral options for HAE," said Dr. Manning. "These results demonstrate that sebetralstat, when used as an oral on-demand treatment for attacks occurring among patients receiving berotralstat for LTP, enabled rapid treatment and symptom improvement. If approved, sebetralstat could transform the treatment landscape for physicians and patients who prefer to manage HAE without needles." "Injectable on-demand treatments have side effects and logistical obstacles that hinder adequate disease control and drive an over-reliance on LTP," said Paul Audhya, MD, MBA, Chief Medical Officer of KalVista. "LTP does not, however, always yield the anticipated reductions in attacks, possibly due to adherence issues in a chronic lifelong setting. Sebetralstat has the potential to enable early treatment of attacks, thereby halting progression at an early stage and reducing morbidity, even among patients on LTP. By overcoming the barriers imposed by current injectable on-demand therapies, sebetralstat could shift the treatment paradigm and become the foundation of HAE management." Links to all presentations can be found on the KalVista website under Publications. About the KONFIDENT Phase 3 TrialThe KONFIDENT phase 3 clinical trial was a randomized, double-blind, 3-way crossover trial evaluating the safety and efficacy of sebetralstat 300 mg and 600 mg versus placebo for the on-demand treatment of HAE in adult and pediatric patients aged 12 years and older. The trial randomized 136 HAE patients from 66 clinical sites across 20 countries, making it the largest clinical trial ever conducted in HAE. In the trial, participants treated each eligible attack with up to two doses of study drug and treated up to three attacks over the course of the study. The trial included Type I and Type II HAE patients who had at least two documented HAE attacks 90 days prior to randomization and also included patients receiving long-term prophylaxis. About the KONFIDENT-S TrialKONFIDENT-S is an open-label extension trial with numerous real-world elements evaluating the long-term safety and efficacy of sebetralstat for the on-demand treatment of HAE attacks in adults and pediatric patients aged 12 years and older with HAE Type I or Type II. KalVista is transitioning ongoing trial participants to a novel oral disintegrating tablet (ODT) formulation to support a planned 2026 sNDA filing. If approved, the ODT formulation would provide people living with HAE with an alternative, novel option for oral, on-demand treatment. About SebetralstatSebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. About Hereditary AngioedemaHereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. Forward-Looking StatementsThis press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. View source version on Contacts Jenn SnyderVice President, Corporate Affairs(617) 448-0281jsnyder@ Ryan BakerHead, Investor Relations(617) Sign in to access your portfolio
