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Associated Press
an hour ago
- Business
- Associated Press
Corvus Pharmaceuticals Announces Full Data from Cohort 3 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis
Cohort 3 demonstrates earlier and deeper responses compared to cohorts 1-2 All three cohorts show separation from placebo with statistically significant difference from placebo at day 28 Cohort 3 demonstrates clinically meaningful reduction in itch as early as day 8 Enrollment initiated in extension cohort study exploring the same cohort 3 dose (200 mg BID) for a longer 8-week treatment period SOUTH SAN FRANCISCO, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The data includes 28-day follow up results for all patients in cohort 3 and continues to show earlier and deeper responses in cohort 3 (200 mg twice per day, total daily dose 400 mg) compared to cohorts 1 and 2 (100 mg twice per day and 200 mg once per day, total daily dose 200 mg). Overall, data from cohorts 1-3 of the trial have demonstrated a favorable safety and efficacy profile, including a statistically significant improvement in Eczema Area and Severity Index (EASI) score for the soquelitinib treated patients compared to placebo at day 28 (p=0.036). 'The complete 28-day data from cohort 3 of our Phase 1 trial of soquelitinib in patients with atopic dermatitis is in-line with the data update we provided at the Society for Investigative Dermatology meeting last month,' said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. 'We are encouraged that results from cohort 3 continue to show earlier and deeper responses, along with a reduction in itch, which is an important factor for patients. We look forward to exploring the potential for further improvement in patient results with longer treatment duration that is being studied in our recently initiated extension cohort. Overall, the data to date is supportive of our view that ITK inhibition with soquelitinib has the potential to be a safe, effective and convenient new option for patients with atopic dermatitis and other immune diseases.' Dr. Miller will highlight the new interim data in a presentation at the Jefferies Global Healthcare Conference, which is scheduled for 9:20 am ET / 6:20 am PT on Thursday, June 5, 2025. The live webcast, which will include presentation slides, may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus' website for 90 days. Soquelitinib Interim Data from the Atopic Dermatitis Phase 1 Clinical Trial As of May 28, 2025, enrollment in cohorts 1, 2 and 3 has been completed for a total of 48 patients and all patients (36 receiving soquelitinib and 12 placebos) had completed the 28-day treatment course. Patients in cohort 3 had more advanced disease with a higher mean baseline EASI score compared to patients in cohorts 1 and 2. At 28 days, the mean reduction in EASI for cohort 3 (n=12) was 64.8%, compared to 54.6% for cohort 1 and 2 combined (n=24) and 34.4% for placebo (n=12). The graphs below (Figures 1 and 2) show the kinetics of response for each of the cohorts and for the combined cohorts 1, 2 and 3. The placebo patients (n=4 per cohort, total n=12) are combined in both graphs. Separation of the curves for patients receiving active drug began at day 15 and increased by day 28 for cohorts 1 and 2. Cohort 3 patients experienced earlier and deeper separation from placebo starting by day 8. EASI scores continue to improve further in treated patients from all cohorts out to day 58. Figure 1: Percent Reduction in Mean EASI Score for Cohorts 1, 2 and 3 . Mean percent change in EASI score over time is shown. Treatment beginning is designated 'Baseline' and days post-baseline are shown. Screening to baseline data is shown and demonstrates relative disease stability. The study blinding remains in effect for the entire 58-day period. Numbers at the top of the graphs indicate numbers of patients evaluated at the various time points. Figure 2: Percent Reduction in Mean EASI Score for Combined Cohorts 1, 2 and 3. The data is displayed below with cohorts combined. Figure 3 below shows the percent of patients that achieved IGA (Investigator Global Assessment) 0 or 1 or EASI 75 at day 28 of treatment. The placebo patients from cohort 1 (n=4), cohort 2 (n=4) and cohort 3 (n=4) are combined, with no placebo patients achieving IGA 0 or 1 or EASI 75. IGA 0 or 1 and EASI 75 have been determined by the U.S. Food and Drug Administration (FDA) to be clinically meaningful and approvable endpoints and have been the endpoints used in clinical trials for other FDA approved treatments for atopic dermatitis. Four additional patients in cohort 3 are now included in the results as compared to the data reported at the Society for Investigative Dermatology (SID) annual meeting in May 2025 (SID data was as of May 6; these four patients had not yet completed the 28-day treatment course). One of the four patients achieved EASI 75 (this patient experienced an 89% reduction in EASI score) and IGA 1 at day 28 of treatment. Figure 3: Percent Patients Achieving Endpoints IGA 0 or 1, EASI 75 at Day 28 of Treatment Patient Reported Reductions in Itch Patients in the trial recorded the intensity of their pruritus, or itch, using the Peak Pruritus Numerical Rating Scale (PP-NRS), which rates the severity of itch on a scale from 0 (no itch) to 10 (the worst itch imaginable). A reduction of ≥4 points from baseline on the PP-NRS is considered to be a clinically meaningful result. In cohort 3, of the patients for whom adequate PP-NRS data was available, 4 of 8 (50%) had a ≥4 point reduction in PP-NRS score from baseline at day 28, with a reduction in itch seen as early as day 8. Of the remaining patients, two had baseline PP-NRS of less than 4 and two had incomplete PP-NRS data. 1 of 10 evaluable placebo patients (10%) experienced a ≥4 point reduction in PP-NRS score at Day 28. Safety Data As of May 28, 2025, no new safety signals have been observed. Soquelitinib was well tolerated, with no dose limiting toxicities (DLTs) and no clinically significant laboratory abnormalities observed in any of the cohorts. No interruption of drug dosing was seen in any of the cohorts. Grade 1/2 adverse events (treatment related and unrelated) were seen in 38.9% of patients receiving soquelitinib and 25% receiving placebo. Only one treatment related adverse event of grade 1 nausea was reported with soquelitinib treatment. Serum Cytokine and Other Biomarker Studies As reported previously, relationships between reductions in certain cytokines with improvement in EASI scores were observed. Reductions in serum cytokine levels were seen for IL-5, IL-9, IL-17, IL-31, IL-33, TSLP and TARC. Differences between responding and non-responding patients were found, while no such relationships were seen in the placebo group, and patients in cohort 3 had greater reductions in cytokines compared to cohorts 1 and 2. Increasing trends were seen in numbers of circulating T regulatory cells, consistent with the presumed mechanism of action of soquelitinib. Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial Extension Cohort Corvus also announced that the first patient(s) has/have been enrolled in the recently announced extension cohort of the Phase 1 trial. This cohort is planned to enroll 24 patients randomized 1:1 between active and placebo, with patients in the treatment group receiving the same dose as cohort 3 – 200 mg orally twice per day. The treatment period for this group is 8 weeks, compared to 4 weeks in cohorts 1-3, with the same 30-day follow-up period with no treatment. About Corvus Pharmaceuticals Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company's lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit or follow the Company on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements related to the potential of the Company's product candidates including soquelitinib and the potential for further improvement in patient results in the extension cohort of the Phase 1 trial of soquelitinib in patients with atopic dermatitis, the design and planned enrollment of the extension cohort, data in support of ITK inhibition with soquelitinib and its potential for patients, and continued advancement of the Company's clinical pipeline. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as 'believe,' 'expect,' 'anticipate,' 'intend,' 'plan,' 'estimate,' 'seek,' 'will,' 'may' or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company's control. The Company's actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the Securities and Exchange Commission on May 8, 2025, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company's ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company's estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company's ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Company's ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. INVESTOR CONTACT: Leiv Lea Chief Financial Officer Corvus Pharmaceuticals, Inc. +1-650-900-4522 [email protected] MEDIA CONTACT: Sheryl Seapy Real Chemistry +1-949-903-4750 [email protected] Figures accompanying this announcement are available at:
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Business Standard
a day ago
- Business
- Business Standard
Sun Pharma halts development of SCD-044 drug after trial disappointment
Sun Pharmaceutical Industries on Tuesday announced that it will discontinue development of its experimental oral drug, SCD-044, following disappointing results in Phase 2 clinical trials for the treatment of moderate to severe psoriasis and atopic dermatitis (eczema). The trial did not achieve the primary objective: a 75 per cent improvement in the EASI (Eczema Area and Severity Index) score by Week 16, the company said. The Phase 2 clinical trial enrolled 250 patients and compared three different dosages of SCD-044 with a placebo. The study followed a randomised, double-blind, placebo-controlled design—standard methodology intended to minimise bias in clinical research. 'While we are disappointed with the top-line results of the clinical trials, we would like to thank all the psoriasis and atopic dermatitis patients, the healthcare professionals and administrators who participated in these pivotal clinical trials,' said Dr Marek Honczarenko, Senior Vice-President and Head of Global Specialty Development at Sun Pharma. Shares of Sun Pharmaceutical closed at ₹1,667.65 on Tuesday, down ₹7.25 or 0.43 per cent. In the fourth quarter of FY25, the company reported a 19 per cent year-on-year decline in net profit to ₹2,153.9 crore, compared with ₹2,658.74 crore in the same quarter of the previous fiscal.
Business Wire
09-05-2025
- Health
- Business Wire
LEO Pharma announces Positive Topline Phase 2b Results for Temtokibart in Moderate-to-Severe Atopic Dermatitis
BALLERUP, Denmark--(BUSINESS WIRE)-- NOT INTENDED FOR UK MEDIA LEO Pharma A/S, a global leader in medical dermatology, today announced positive topline results of the phase 2b trial with temtokibart, an investigational IL-22RA1 antagonist, for the potential treatment of adults with moderate-to-severe atopic dermatitis (AD). The study was a phase 2b, randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose-finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart, also called LEO 138559, in adult subjects with moderate-to-severe AD. 1 The phase 2b trial achieved positive results for the primary endpoint based on percentage change in EASI (Eczema Area and Severity Index) from baseline to Week 16 for 3 highest doses in adults with moderate-to-severe AD. The treatment was generally well-tolerated, with no dose dependency, and the majority of adverse events observed were non-serious, mild or moderate in severity, and not considered treatment related. ' Atopic dermatitis is a complex immunological condition, and patients living with this debilitating disease still face unmet needs. LEO Pharma is committed to making a fundamental difference for these patients, and we are encouraged by the results of this phase 2b trial, which has explored how to target the disease from a different angle with a different mechanism of action, compared to what is commonly used today to treat AD,' said Dr Jacob Pontoppidan Thyssen, Chief Scientific Officer & Executive Vice President, Science, Search & Innovation at LEO Pharma. ' These results further add to the understanding of the mode of action of temtokibart and its potential abilities to address unmet needs in diseases where the IL-22 pathway is known to play a key role – in medical dermatology and beyond.' Temtokibart is an investigational monoclonal antibody for the treatment of moderate-to-severe AD, which blocks the IL-22RA1 receptor subunit thereby inhibiting the effect of the interleukin-22 (IL-22) cytokine – known to be elevated in patients with atopic dermatitis. 2-4 LEO Pharma and argenx, a global immunology company, formed a strategic alliance in 2015 to develop innovative antibody-based solutions for the treatment of chronic inflammation that underlies many skin conditions. LEO Pharma and argenx jointly developed temtokibart under this research agreement and LEO Pharma has subsequently obtained the exclusive license to develop and commercialize temtokibart. LEO Pharma is currently collecting and evaluating the full data set. Detailed results from the phase 2b trial are planned to be submitted for scientific presentation and publication at a later date. For more information on the trial (NCT05923099) go to About the Phase 2b trial The temtokibart phase 2b trial (NCT05923099) is a randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart in adult patients with moderate-to-severe atopic dermatitits. 1 Patients were randomized to receive one of four doses of temtokibart or placebo. 1 The primary endpoint is percent change in EASI from baseline to Week 16. 1 The key secondary endpoint is number of treatment-emergent adverse events from baseline to Week 16 per subject. 1 About atopic dermatitis Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions. 5 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation. 6 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology. 7,8 Excessive IL-22 production is also known to contribute to the pathogenesis of AD. 9,10 About investigational temtokibart Temtokibart is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in phase 2 development for the potential treatment of moderate-to-severe atopic dermatitis. 3,4 It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and also the effects of IL-20 and IL-24 signaling. 3,4 Temtokibart does not bind to the IL-22 cytokine itself. 3,4 LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people's lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit References NCT05923099. Available at: Accessed September 2024. Bangert C, et al. Presented at European Academy of Dermatology & Venereology (EADV) 2024 Annual Meeting, Amsterdam, 25–28 September 2024. Thaçi D, et al. Presented at American Academy of Dermatology (AAD) 2023 Annual Meeting, New Orleans, 17–21 March 2023. Thaçi D, et al. Presented at European Academy of Dermatology and Venereology (EADV) 2023 Annual Meeting, Berlin, 11–13 October 2023. Weidinger S, et al. Lancet 2016;387:1109–1122. Boguniewicz M, et al. Immunol Rev 2011;242:233–246. Tubau C, Puig L. Immunotherapy 2021;13:327–344. Bieber T. Allergy 2020;75:54–62. Gittler JK, et al. J Allergy Clin Immunol 2012;130:1344–1354. Nograles K, et al. J Allergy Clin Immunol 2009;123:1244–1252.
Time of India
02-05-2025
- Health
- Time of India
New study finds tofacitinib effective and affordable for refractory atopic dermatitis
New Delhi: New Delhi: Tofacitinib , a Janus kinase (JAK) inhibitor drug, used either as a standalone treatment or alongside other drugs to address moderate to severe cases of rheumatoid arthritis and ankylosing spondylitis, demonstrates effectiveness in managing refractory atopic dermatitis (AD). Tired of too many ads? go ad free now This was revealed in a study published in the Indian Dermatology online journal. Atopic dermatitis (AD) presents as a long-term, recurring inflammatory disorder of the skin, and its characteristic itching significantly affects patients' daily living standards. The research was conducted at the department of dermatology, venereology and leprosy in Atal Bihari Vajpayee Institute of Medical Sciences and Research Institute and Dr Ram Manohar Lohia Hospital. The results established that people who previously showed no response to standard systemic treatments, including oral corticosteroids, cyclosporine and azathioprine, exhibited significant clinical improvement when administered tofacitinib exclusively. The progress was evaluated through decreased Scoring Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI), and Numerical Rating Scale (NRS) measurements at 4-week and 8-week intervals. The principal investigator of the study and dermatologist at RML Hospital, professor Kabir Sardana, explained that their main goal was to evaluate how well tofacitinib worked and its side effects in patients with difficult-to-treat moderate-to-severe AD. Additionally, they aimed to analyse the treatment costs between tofacitinib and dupilumab (approved by the Central Drugs Standard Control Organisation, India) for moderate and severe AD cases. Tired of too many ads? go ad free now The research indicated an average disease duration of three years. Patients displayed moderate to severe pruritus, excoriations, erythema, oozing and crusting. All participants had previously experienced treatment failure or intolerance to systemic therapy; 50% of patients also had other atopic conditions and bronchial asthma. The researchers continued treatment with topical corticosteroids, moisturiser and topical calcineurin inhibitors alongside tofacitinib. Improvements were observed in pruritus, sleep quality, affected body surface area, erythema, excoriation, papulation/edema and lichenification, with notable severity score reductions at four weeks and eight weeks of therapy. Dr Sardana said that EASI 90 was attained by 66% of patients within 8 weeks, with one patient experiencing treatment failure. Patients achieved complete or near-complete disease resolution in an average of 6.1 weeks (ranging from 3-8 weeks). Disease recurrence was observed in 36.3% of patients. Adverse reactions occurred in 41.6% of patients, including herpes zoster, dyslipidemia, anaemia, impetigo, and thrombocytosis. The financial comparison revealed that dupilumab (a monoclonal antibody used to treat various allergic conditions, including atopic dermatitis, asthma, and nasal polyps) therapy costs 122 times more than tofacitinib treatment over an 8-week period.
