Latest news with #Kiniksa
Yahoo
05-06-2025
- Business
- Yahoo
Kiniksa Pharmaceuticals Announces Trial Design of Planned Phase 2/3 Clinical Trial of KPL-387 in Recurrent Pericarditis
– KPL-387 Phase 2/3 trial on track to initiate in mid-2025; Phase 2 data expected in 2H 2026 –– KPL-387 Phase 1 single ascending dose data support profile for monthly dosing –– Presentation and webcast at Jefferies 2025 Global Healthcare Conference scheduled for 12:50 pm ET today– LONDON, June 05, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today announced details for its planned Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis, expected to initiate in the middle of 2025. KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling activity of the cytokines interleukin-1α (IL-1α) and interleukin-1β (IL-1β). 'We leveraged our expertise in this indication and experience with the RHAPSODY study design to plan this pivotal phase 2/3 study. We believe KPL-387 could provide a meaningful addition to the therapeutic options available to patients,' said John F. Paolini, M.D., Ph.D., FACC, Chief Medical Officer of Kiniksa. 'We are eager to advance KPL-387, with its target profile of monthly dosing in a single subcutaneous injection in a liquid formulation, through this pivotal Phase 2/3 clinical trial and to patients in need. We expect to initiate the study in the middle of this year, with data from the dose-focusing portion expected in the second half of 2026.' Phase 2/3 Clinical Trial of KPL-387 in Recurrent PericarditisKiniksa is on track to initiate a Phase 2/3 clinical trial designed to evaluate the efficacy and safety of KPL-387 administered subcutaneously (SC) in patients with recurrent pericarditis. The trial will consist of three overlapping parts combined into a single protocol: a dose-focusing portion (Phase 2), a pivotal portion (Phase 3), and long-term extensions (LTE). The dose-focusing portion of the trial will enroll up to approximately 80 participants with recurrent pericarditis randomized in a 1:1:1:1 ratio to receive KPL-387 300 mg SC biweekly, 300 mg SC monthly, 100 mg SC biweekly, and 100 mg SC monthly. The primary efficacy endpoint is time to treatment response at Week 24. Subsequently, active, enrolled participants may be eligible to enter an LTE. Following the dose-focusing portion, enrollment of up to approximately 85 patients with recurrent pericarditis into the pivotal portion of the clinical trial will commence. In the first period, a single-blind run-in (RI), all participants will receive KPL-387 while conventional oral pericarditis medications are weaned and discontinued. Participants achieving Clinical Response in the RI period will then be randomized in a 1:1 ratio to receive either KPL-387 or placebo in an event-driven, double-blind, randomized withdrawal (RW) period. The primary efficacy endpoint is time to first-adjudicated pericarditis recurrence during the RW period. Participants in the RW period may be eligible to enter an LTE. The Phase 2/3 clinical trial design is supported by data from the Phase 1 first-in-human single ascending dose study. Presentation Information Ross Moat, Chief Commercial Officer, and Dr. John Paolini, Chief Medical Officer, will provide a corporate presentation at the Jefferies 2025 Global Healthcare Conference at 12:50 p.m. Eastern Time on Thursday, June 5, 2025. A live webcast of Kiniksa's presentation will be accessible through the Investors & Media section of the company's website at A replay of the event will also be available on Kiniksa's website within approximately 48 hours after the event. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa's portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit About KPL-387KPL-387 is an independently developed, investigational, fully human immunoglobulin G2 (IgG2) monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling of the cytokines IL-1α and IL-1β. Kiniksa believes KPL-387 could expand the treatment options for recurrent pericarditis patients by enabling dosing with a single monthly SC injection in a liquid formulation. Forward-Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify forward looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our plan to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026, and that we remain on track to meeting such plan; our target profile of monthly dosing via a single subcutaneous injection in a liquid formulation for KPL-387; our belief that KPL-387 could provide a meaningful addition to therapeutic options available to patients; the design of our Phase 2/3 clinical trial of KPL-387, including the number of participants expected to enroll and our belief that the Phase 3 portion is pivotal; our beliefs about the mechanisms of our assets and potential impact of their approach; and our belief that our portfolio of assets offers the potential for differentiation. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; raw material, important ancillary product and drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; business development activities and their impact on our financial performance and strategy; changes in our operating plan, business development strategy or funding requirements; existing or new competition; and the impact of global economic policy, including any uncertainty in national and international markets. These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption 'Risk Factors' contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press Investor & Media ContactJonathan Kirshenbaum(781) 829-3949jkirshenbaum@ in to access your portfolio
Yahoo
29-05-2025
- Business
- Yahoo
Kiniksa Pharmaceuticals to Present at Upcoming Investor Conferences
LONDON, May 29, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) today announced that management will present at the following investor conferences in June: Jefferies 2025 Global Healthcare Conference on Thursday, June 5 at 12:50 p.m. Eastern Time Goldman Sachs 46th Annual Global Healthcare Conference on Tuesday, June 10 at 8:00 a.m. Eastern Time – Fireside Chat A live webcast of Kiniksa's presentations will be accessible through the Investors & Media section of the company's website at A replay of the events will also be available on Kiniksa's website within approximately 48 hours after the event. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa's portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit Kiniksa Investor & Media ContactJonathan Kirshenbaum (781) 829-3949jkirshenbaum@ 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
30-04-2025
- Health
- Yahoo
Kiniksa Pharmaceuticals Announces GRAMMY® Award-Winning Country Star, Carly Pearce, Joins the Life DisRPted™ Campaign, Adding to Voices Advocating for Awareness of Recurrent Pericarditis
This embedded content is not available in your region. – Pearce joins NHL Hall-of-Famer, Henrik Lundqvist, to educate patients and caregivers about the importance of accurate and early diagnosis of recurrent pericarditis, a chronic autoinflammatory disease of the heart that is often underdiagnosed or misdiagnosed – LONDON, April 30, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, has partnered with Country Music Association, Academy of Country Music, and GRAMMY Award-winning country star, Carly Pearce, to share her personal experience with recurrent pericarditis and encourage self-advocacy through Kiniksa's Life DisRPted campaign. Pearce announced that she was diagnosed with recurrent pericarditis while on tour in 2024, after experiencing multiple flares over the previous four years. 'It wasn't until my fourth recurrent pericarditis flare — after seeing many doctors and receiving various diagnoses — that I was finally accurately diagnosed with recurrent pericarditis. During this time, it wasn't only the symptoms that took a toll on me, but also the fear of the next flare. I remember thinking, 'I'm afraid to get on the airplane,' and 'I'm afraid to get on the stage, because what if it happens again?'' said Pearce, Grand Ole Opry and Kentucky Music Hall of Fame member. 'My hope is that through my work on the Life DisRPted campaign, I inspire others to advocate for themselves, share their symptoms, and not wait to talk to their doctors.' 'Greater awareness is the first step to earlier diagnosis and intervention, which is critical for protecting patients from unnecessary suffering and future recurrent pericarditis flares,' said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. 'Carly understands the physical and emotional toll of this disease firsthand, and we are honored to help her share her powerful story. By providing information on recognizing symptoms, understanding the disease, and accessing appropriate care, our goal is to empower patients with the tools to take control back from recurrent pericarditis.' Patients experiencing recurrent pericarditis flares, characterized by chest pain but often also tiredness, shortness of breath, or inability to exercise as much as normal, suffer wide-ranging effects on quality of life, physical activity, and overall well-being. Recurrent pericarditis can be challenging to diagnose since many different conditions can cause similar symptoms, and recurrent pericarditis may not be the obvious diagnosis. First launched in October 2024 featuring Henrik Lundqvist, former National Hockey League goaltender and Hockey Hall-of-Fame inductee, Life DisRPted is a national campaign focused on raising awareness of recurrent pericarditis, its impact on quality of life, and the critical importance of early diagnosis. Through Life DisRPted, Pearce is sharing her personal journey with recurrent pericarditis in a video titled 'The Power of Knowing,' helping to shed light on the realities of living with the disease and the importance of self-advocacy. The video is available on which also features a downloadable Doctor Discussion Guide to help patients prepare for conversations with their healthcare providers. To hear Carly Pearce's story, visit About Recurrent PericarditisRecurrent pericarditis is a painful and debilitating chronic autoinflammatory cardiovascular disease marked by inflammation of the pericardium and is often associated with changes in electrical conduction and sometimes buildup of fluid around the heart, called pericardial effusion. Recurrent pericarditis symptoms have an impact on quality of life, limit physical activities, and lead to frequent emergency department visits and hospitalizations. Data show that approximately 40,000 patients in the U.S. seek and receive treatment for recurrent pericarditis each year. Of that group, approximately 14,000 patients experience two or more recurrences due to persistent underlying disease or inadequate response to conventional therapies, such as nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, and corticosteroids. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa's portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit About Carly PearceFiercely rooted in the classics, GRAMMY Award-winning singer-songwriter Carly Pearce lit a fire with her debut album Every Little Thing and the PLATINUM-certified history-making title track, and she hasn't slowed down since. With the praised release of her highly anticipated fourth album, hummingbird (June 7, Big Machine Records), Pearce continues to resonate with her honest lyrics and timeless musicality. The critically acclaimed album includes the blazing 'truck on fire' as well as lead single 'we don't fight anymore' (featuring Chris Stapleton) which earned Pearce her second GRAMMY nomination for Best Country Duo/Group Performance and fifth Top 5 Country Radio hit. On March 14th, Pearce released hummingbird: no rain, no flowers, a deluxe edition of the album with five new tracks and is currently performing the new music on her headlining hummingbird world tour. Previously, her critically acclaimed and commercially lauded third studio album 29 produced Country Radio chart toppers including 'Never Wanted to Be That Girl' with Ashley McBryde which gave Pearce her second consecutive ACM Music Event of the Year in 2022 and marked the third duet between two solo women to top Billboard's Country Airplay chart. The song also took home the 2022 CMA Musical Event of the Year and won a GRAMMY Award for Best Country Duo/Group Performance, marking Pearce's first, and making history as the first female pairing to win in the category. In addition, Pearce's 3x PLATINUM-certified 'I Hope You're Happy Now' with Lee Brice won both the 2020 CMA Awards Musical Event and 2021 ACM Awards Music Event, plus ACM Single of the Year. Both a Grand Ole Opry and Kentucky Music Hall of Fame member, Pearce recently made her 100th performance at the Grand Ole Opry. For more information, visit Investor ContactJonathan Kirshenbaum(781) 829-3949jkirshenbaum@ Kiniksa Media ContactTyler Gagnon (781) 431-9100tgagnon@ Carly Pearce Media ContactsErica Avery A video accompanying this announcement is available at in to access your portfolio
Associated Press
29-04-2025
- Business
- Associated Press
Kiniksa Pharmaceuticals Reports First Quarter 2025 Financial Results and Recent Portfolio Execution
LONDON, April 29, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today reported first quarter 2025 financial results and recent portfolio execution. 'Kiniksa continues to drive strong growth with ARCALYST. In the first quarter of 2025, our robust commercial execution resulted in a meaningful increase in active commercial patients, driven by increases to the prescriber base, longer average total duration of treatment, and changes to Medicare Part D. As a result of strong first quarter performance, we are increasing our expected 2025 ARCALYST net sales to between $590 and $605 million from our previous guidance of between $560 and $580 million,' said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. 'Also, we are excited about the potential of KPL-387 to be an additional treatment option for patients by enabling dosing with a single monthly subcutaneous injection in a liquid formulation. We remain on track to initiate the KPL-387 Phase 2/3 recurrent pericarditis trial in the middle of this year.' Portfolio Execution ARCALYST (IL-1α and IL-1β cytokine trap) KPL-387 (monoclonal antibody IL-1 receptor antagonist) KPL-1161 (Fc-modified monoclonal antibody IL-1 receptor antagonist) Financial Results Financial Guidance Conference Call Information About Kiniksa Kiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa's portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit About ARCALYST ARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. ARCALYST was discovered by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the U.S. Food and Drug Administration (FDA) for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug exclusivity to ARCALYST in 2021 for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients 12 years and older. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021. IMPORTANT SAFETY INFORMATION ABOUT ARCALYST For more information about ARCALYST, talk to your doctor and see the Product Information. About KPL-387 KPL-387 is an independently developed, investigational, fully human immunoglobulin G2 (IgG2) monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling of the cytokines IL-1α and IL-1β. Kiniksa believes KPL-387 could expand the treatment options for recurrent pericarditis patients by enabling dosing with a single monthly SC injection in a liquid formulation. About KPL-1161 KPL-1161 is an independently developed, investigational, Fc-modified IgG2 monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1α and IL-1β, with a target profile of quarterly SC dosing. Kiniksa is currently engaging in IND-enabling development activities for KPL-1161. Forward-Looking Statements This press release contains forward-looking statements. In some cases, you can identify forward looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our expectation that ARCALYST 2025 net product revenue will be between $590 million and $605 million; our plan to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026, and that we remain on track to meeting such plan; our expectation that our current operating plan will remain cash flow positive on an annual basis; our target profile of monthly dosing via a single subcutaneous injection in a liquid formulation for KPL-387; the expected impact of tariff policy on our gross margins; our target profile of quarterly dosing for KPL-1161; our beliefs about the mechanisms of our assets and potential impact of their approach; and our belief that our portfolio of assets offers the potential for differentiation. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; raw material, important ancillary product and drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; business development activities and their impact on our financial performance and strategy; changes in our operating plan, business development strategy or funding requirements; existing or new competition; and the impact of global economic policy, including any uncertainty in national and international markets. These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption 'Risk Factors' contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. ARCALYST® is a registered trademark of Regeneron Pharmaceuticals, Inc. Every Second Counts!® Kiniksa Investor Contact Jonathan Kirshenbaum (781) 829-3949 [email protected] Kiniksa Media Contact Tyler Gagnon (781) 431-9100 [email protected]
Yahoo
24-04-2025
- Business
- Yahoo
Kiniksa Pharmaceuticals to Report First Quarter 2025 Financial Results on April 29, 2025
LONDON, April 24, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) announced today that it will host a conference call and live webcast on Tuesday, April 29, 2025 at 8:30 a.m. Eastern Time to report its first quarter 2025 financial results and recent portfolio execution. A live webcast will be accessible through the Investors & Media section of the company's website at Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the event will also be available on Kiniksa's website within approximately 48 hours after the event. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa's portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit Investor ContactJonathan Kirshenbaum(781) 829-3949jkirshenbaum@ Kiniksa Media ContactTyler Gagnon (781) 431-9100tgagnon@ in to access your portfolio
