Latest news with #ESK-001
Business Insider
3 days ago
- Business
- Business Insider
Alumis resumed with an Overweight at Morgan Stanley
Morgan Stanley resumed coverage of Alumis (ALMS) with an Overweight rating and $23 price target The firm updated its model for the Acelyrin merger and Q1 earnings. The Phase 3 data from Alumis' lead pipeline program ESK-001 in psoriasis in Q1 of 2026 represents the next key catalyst for the shares, the analyst tells investors in a research note. Morgan believes the company's pipeline is on track. Confident Investing Starts Here:
Yahoo
7 days ago
- Business
- Yahoo
Alumis Completes Enrollment of Pivotal Phase 3 ONWARD Clinical Program of Lead Candidate ESK-001, a Highly Selective, Next-Generation Oral TYK2 Inhibitor for the Treatment of Moderate-to-Severe Plaque Psoriasis
-Topline readout expected in early Q1 2026- SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis. "We are excited to announce the completion of patient enrollment in our pivotal Phase 3 ONWARD clinical program evaluating ESK-001 for moderate-to-severe plaque psoriasis,' said Martin Babler, President and Chief Executive Officer of Alumis. 'With over 1,700 patients enrolled across the two trials, this milestone reflects the dedication of our patients, investigators, and the Alumis team, whose efforts have made it possible. We remain on track to report topline results in early Q1 2026, bringing us closer to delivering transformative treatment solutions for patients in need." 'As we advance the development of ESK-001, we recognize the ongoing challenges patients with plaque psoriasis face in finding effective and convenient treatment options," said Dr. Jörn Drappa, Alumis' Chief Medical Officer. "Many patients cycle through therapies due to the inconvenience of injectable biologics and the diminishing effectiveness of oral treatments. With its differentiated profile, ESK-001 has the potential to provide a well-tolerated oral TYK2 inhibitor that delivers durable, biologic-like clinical responses, bridging a critical gap in treatment." The Phase 3 ONWARD clinical program consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis. ONWARD 3, an optional long-term extension trial for patients who have completed Week 24, is currently ongoing to assess the durability, maintenance of response, and long-term safety of ESK-001. About ESK-001 Alumis' lead clinical candidate, ESK-001, is a highly selective, next-generation oral TYK2 inhibitor that is designed to correct immune dysregulation across a spectrum of diseases driven by proinflammatory mediators, including IL-23, IL-17, and type 1 interferon (IFN). ESK-001's selective targeting is designed to deliver maximal inhibition while minimizing off-target binding and effects. The efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis are currently being evaluated in the Phase 3 ONWARD clinical program, which consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 (NCT06586112) and ONWARD2 (NCT06588738). Over 1,700 patients were enrolled across the two trials and randomized 2:1:1 to receive ESK-001 40 mg twice-daily, placebo or apremilast. The co-primary efficacy endpoints will be the proportion of patients with moderate-to-severe plaque psoriasis achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and sPGA score 0/1 of ESK-001 compared to placebo at Week 16. Patients completing Week 24 will have the opportunity to participate in a long-term extension trial, ONWARD3, that will evaluate durability and maintenance of response and long-term safety. The Phase 3 clinical program is supported by positive data from the Phase 2 STRIDE clinical trial (NCT05600036), and by the long-term open-label extension (CT05739435) which is currently ongoing. In parallel with the Phase 3 clinical program, Alumis is developing a once-daily modified-release oral formulation of ESK-001 designed to replace the current immediate-release oral formulation that is dosed twice daily. ESK-001 is also being evaluated in LUMUS, a Phase 2b clinical trial for the treatment of patients with systemic lupus erythematosus. In addition, Alumis continues to leverage its precision data analytics platform to explore ESK-001's potential application in other immune-mediated conditions. About AlumisAlumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of ESK-001 for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit or follow us on LinkedIn or X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of federal securities laws, including the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of Alumis' topline readout in its ONWARD Phase 3 program, the potential for ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, any expectations regarding the safety, efficacy or tolerability of ESK-001 and statements regarding Alumis' future plans and prospects including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis' current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis' forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis' ability to advance ESK-001 and to obtain regulatory approval of and ultimately commercialize Alumis' clinical candidates, the timing and results of preclinical and clinical trials, Alumis' ability to fund development activities and achieve development goals, Alumis' ability to protect its intellectual property and other risks and uncertainties described in Alumis' filings with the Securities and Exchange Commission (SEC), including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. CONTACT: Alumis Contact Information Teri Dahlman Red House Communications teri@
Associated Press
7 days ago
- Business
- Associated Press
Alumis Completes Enrollment of Pivotal Phase 3 ONWARD Clinical Program of Lead Candidate ESK-001, a Highly Selective, Next-Generation Oral TYK2 Inhibitor for the Treatment of Moderate-to-Severe Plaque Psoriasis
SOUTH SAN FRANCISCO, Calif., May 29, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharma company developing next-generation targeted therapies for patients with immune-mediated diseases, today announced the completion of patient enrollment in its pivotal Phase 3 ONWARD clinical program of ESK-001 for the treatment of moderate-to-severe plaque psoriasis. 'We are excited to announce the completion of patient enrollment in our pivotal Phase 3 ONWARD clinical program evaluating ESK-001 for moderate-to-severe plaque psoriasis,' said Martin Babler, President and Chief Executive Officer of Alumis. 'With over 1,700 patients enrolled across the two trials, this milestone reflects the dedication of our patients, investigators, and the Alumis team, whose efforts have made it possible. We remain on track to report topline results in early Q1 2026, bringing us closer to delivering transformative treatment solutions for patients in need.' 'As we advance the development of ESK-001, we recognize the ongoing challenges patients with plaque psoriasis face in finding effective and convenient treatment options,' said Dr. Jörn Drappa, Alumis' Chief Medical Officer. 'Many patients cycle through therapies due to the inconvenience of injectable biologics and the diminishing effectiveness of oral treatments. With its differentiated profile, ESK-001 has the potential to provide a well-tolerated oral TYK2 inhibitor that delivers durable, biologic-like clinical responses, bridging a critical gap in treatment.' The Phase 3 ONWARD clinical program consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 and ONWARD2, designed to evaluate the efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis. ONWARD 3, an optional long-term extension trial for patients who have completed Week 24, is currently ongoing to assess the durability, maintenance of response, and long-term safety of ESK-001. About ESK-001 Alumis' lead clinical candidate, ESK-001, is a highly selective, next-generation oral TYK2 inhibitor that is designed to correct immune dysregulation across a spectrum of diseases driven by proinflammatory mediators, including IL-23, IL-17, and type 1 interferon (IFN). ESK-001's selective targeting is designed to deliver maximal inhibition while minimizing off-target binding and effects. The efficacy and safety of ESK-001 in adult patients with moderate-to-severe plaque psoriasis are currently being evaluated in the Phase 3 ONWARD clinical program, which consists of two parallel global Phase 3, multi-center, randomized, double-blind placebo-controlled 24-week clinical trials, ONWARD1 ( NCT06586112 ) and ONWARD2 ( NCT06588738 ). Over 1,700 patients were enrolled across the two trials and randomized 2:1:1 to receive ESK-001 40 mg twice-daily, placebo or apremilast. The co-primary efficacy endpoints will be the proportion of patients with moderate-to-severe plaque psoriasis achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and sPGA score 0/1 of ESK-001 compared to placebo at Week 16. Patients completing Week 24 will have the opportunity to participate in a long-term extension trial, ONWARD3, that will evaluate durability and maintenance of response and long-term safety. The Phase 3 clinical program is supported by positive data from the Phase 2 STRIDE clinical trial (NCT05600036), and by the long-term open-label extension (CT05739435) which is currently ongoing. In parallel with the Phase 3 clinical program, Alumis is developing a once-daily modified-release oral formulation of ESK-001 designed to replace the current immediate-release oral formulation that is dosed twice daily. ESK-001 is also being evaluated in LUMUS, a Phase 2b clinical trial for the treatment of patients with systemic lupus erythematosus. In addition, Alumis continues to leverage its precision data analytics platform to explore ESK-001's potential application in other immune-mediated conditions. About Alumis Alumis is a late-stage biopharma company developing next-generation targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases. Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2 inhibitors, consisting of ESK-001 for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit or follow us on LinkedIn or X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements. All statements, other than statements of historical facts, including without limitation those regarding the timing of Alumis' topline readout in its ONWARD Phase 3 program, the potential for ESK-001 to treat moderate-to-severe plaque psoriasis and systemic lupus erythematosus, any expectations regarding the safety, efficacy or tolerability of ESK-001 and statements regarding Alumis' future plans and prospects including development of its clinical pipeline; and any assumptions underlying any of the foregoing, are forward-looking statements. Any forward-looking statements in this press release are based on Alumis' current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in Alumis' forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to Alumis' ability to advance ESK-001 and to obtain regulatory approval of and ultimately commercialize Alumis' clinical candidates, the timing and results of preclinical and clinical trials, Alumis' ability to fund development activities and achieve development goals, Alumis' ability to protect its intellectual property and other risks and uncertainties described in Alumis' filings with the Securities and Exchange Commission (SEC), including any future reports Alumis may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Alumis Contact Information Teri Dahlman Red House Communications [email protected]
Globe and Mail
08-04-2025
- Business
- Globe and Mail
Psoriasis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight's, ' Psoriasis Pipeline Insight 2025 ' report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in Psoriasis pipeline landscape. It covers the Psoriasis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Psoriasis pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Psoriasis Pipeline. Dive into DelveInsight's comprehensive report today! @ Psoriasis Pipeline Outlook Key Takeaways from the Psoriasis Pipeline Report In April 2025, Alumis Inc. announced a study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001. Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. DelveInsight's Psoriasis pipeline report depicts a robust space with 80+ active players working to develop 80+ pipeline therapies for Psoriasis treatment. The leading Psoriasis Companies such as Mylan, Biocad, Bristol-Myers Squibb, Celltrion, Coherus BioSciences, Janssen Pharmaceuticals, Can-Fite Biopharma, Arcutis Biotherapeutics, Amgen, Iltoo Pharma, GlaxoSmithKline, Galectin Therapeutics, Evelo Biosciences, Galderma, BioMimetix JV, Menlo Therapeutics Inc., Aristea Therapeutics, UNION Therapeutics, MetrioPharm, Sienna Biopharmaceuticals and others. Promising Psoriasis Pipeline Therapies such as Hypericin, Cetaphil, EDP1815, AX-158, Calcipotriol, MP1032, Risankizumab, Certolizumab Pegol, and others. Stay ahead with the most recent pipeline outlook for Psoriasis. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Psoriasis Treatment Drugs Psoriasis Emerging Drugs Profile Topical roflumilast: Arcutis Biotherapeutics Topical roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase type 4 (PDE4), an intracellular enzyme that increases the production of proinflammatory mediators and decreases production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and chronic obstructive pulmonary disease (COPD). The therapy is in Phase III clinical development for the treatment of Plaque Psoriasis. GSK2982772: GlaxoSmithKline GSK2982772 is an ATP competitive receptor-interacting protein-1 (RIP1) kinase (RIPK1) inhibitor with the IC50 value of 16 nM. GSK2982772 potently binds to RIP1 with exquisite kinase specificity and has excellent activity in blocking many TNF-dependent cellular responses. RIP1 has emerged as an important upstream kinase that has been shown to regulate inflammation through both scaffolding and kinase specific functions. The molecule is in Phase I clinical development for the treatment of Psoriasis. The Psoriasis Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Psoriasis with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Psoriasis Treatment. Psoriasis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Psoriasis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Psoriasis market Explore groundbreaking therapies and clinical trials in the Psoriasis Pipeline. Access DelveInsight's detailed report now! @ New Psoriasis Drugs Psoriasis Companies Mylan, Biocad, Bristol-Myers Squibb, Celltrion, Coherus BioSciences, Janssen Pharmaceuticals, Can-Fite Biopharma, Arcutis Biotherapeutics, Amgen, Iltoo Pharma, GlaxoSmithKline, Galectin Therapeutics, Evelo Biosciences, Galderma, BioMimetix JV, Menlo Therapeutics Inc., Aristea Therapeutics, UNION Therapeutics, MetrioPharm, Sienna Biopharmaceuticals and others. Psoriasis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Parenteral Intravitreal Subretinal Topical. Molecule Type Psoriasis Products have been categorized under various Molecule types such as Monoclonal Antibody Peptides Polymer Small molecule Gene therapy Product Type Unveil the future of Psoriasis Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Psoriasis Market Drivers and Barriers Scope of the Psoriasis Pipeline Report Coverage- Global Psoriasis Companies- Mylan, Biocad, Bristol-Myers Squibb, Celltrion, Coherus BioSciences, Janssen Pharmaceuticals, Can-Fite Biopharma, Arcutis Biotherapeutics, Amgen, Iltoo Pharma, GlaxoSmithKline, Galectin Therapeutics, Evelo Biosciences, Galderma, BioMimetix JV, Menlo Therapeutics Inc., Aristea Therapeutics, UNION Therapeutics, MetrioPharm, Sienna Biopharmaceuticals and others. Psoriasis Pipeline Therapies- Hypericin, Cetaphil, EDP1815, AX-158, Calcipotriol, MP1032, Risankizumab, Certolizumab Pegol, and others. Psoriasis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Psoriasis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Psoriasis Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Psoriasis Companies, Key Products and Unmet Needs Table of Content Introduction Executive Summary Psoriasis: Overview Pipeline Therapeutics Therapeutic Assessment Psoriasis – DelveInsight's Analytical Perspective In-depth Commercial Assessment Psoriasis Collaboration Deals Late Stage Products (Phase III) CT-P43: Celltrion Drug profiles in the detailed report….. Mid Stage Products (Phase II) EDP1815: Evelo Biosciences Drug profiles in the detailed report….. Early Stage Products (Phase I) AZD0284: AstraZeneca Drug profiles in the detailed report….. Early Stage Products (Preclinical) AZD0284: AstraZeneca Drug profiles in the detailed report….. Inactive Products Psoriasis Key Companies Psoriasis Key Products Psoriasis- Unmet Needs Psoriasis- Market Drivers and Barriers Psoriasis- Future Perspectives and Conclusion Psoriasis Analyst Views Psoriasis Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
