FTP-637
- Generic Name
- FTP-637
Robust Pipeline of 80+ Therapies Advancing in Psoriasis Treatment Landscape
• DelveInsight's 2025 Psoriasis Pipeline Report reveals over 80 companies developing 80+ pipeline therapies, highlighting significant R&D investment in this therapeutic area.
• Promising treatments in development include topical roflumilast (Arcutis Biotherapeutics) in Phase III trials and GSK2982772 (GlaxoSmithKline), a novel RIPK1 inhibitor in Phase I development.
• Alumis Inc. has initiated a long-term extension study for ESK-001 in moderate to severe plaque psoriasis patients, evaluating safety, efficacy, and durability of response over 24 weeks.
Alumis to Present 52-Week Phase 2 Data for Novel TYK2 Inhibitor in Psoriasis at AAD 2025
• Alumis will showcase long-term safety and efficacy data for ESK-001, their oral TYK2 inhibitor, in moderate-to-severe plaque psoriasis through multiple presentations at the 2025 AAD annual meeting.
• The company has accelerated the timeline for their Phase 3 ONWARD program, with topline data now expected in Q1 2026, reflecting strong patient enrollment and investigator interest.
• ESK-001 demonstrated sustained PASI score improvements and favorable safety profile in interim 28-week open-label extension data, with most patients achieving PASI 75 at the 40mg twice-daily dose.
Novel Oral Psoriasis Therapies Show Promise: TYK2 Inhibitors Lead Breakthrough Advances
• Deucravacitinib demonstrates superior efficacy over apremilast in psoriasis treatment, with over 53% of patients achieving significant skin clearance at week 16.
• Apremilast maintains its position as a key therapy for mild-to-moderate psoriasis, with 21% of bio-naïve patients achieving treatment goals in the ADVANCE trial.
• Next-generation oral therapies, including JNJ-77242114 and zasocitinib, show promising results in clinical trials, potentially expanding treatment options for psoriasis patients.
Alumis and Acelyrin Announce Merger to Create $737M Clinical-Stage Biopharma Company
• Alumis and Acelyrin have agreed to merge in an all-stock transaction, creating a combined entity with $737 million in cash runway extending into 2027.
• The merged company will retain the Alumis name and prioritize development of two TYK2 inhibitors targeting conditions including psoriasis, lupus, and multiple sclerosis.
• Acelyrin's thyroid eye disease drug lonigutamab is included in the deal but will undergo strategic review to assess its market differentiation potential.
Sotyktu Meets Primary Endpoints in Phase 3 Psoriatic Arthritis Trials
• Bristol Myers Squibb's Sotyktu (deucravacitinib) demonstrated significant efficacy in two Phase 3 trials for active psoriatic arthritis (PsA).
• The POETYK PsA-1 and PsA-2 trials met their primary endpoint, showing a greater proportion of Sotyktu-treated patients achieved ACR20 response at Week 16 compared to placebo.
• Both trials also met key secondary endpoints related to PsA disease activity, with a safety profile consistent with previous studies.
• Sotyktu, a TYK2 inhibitor, could potentially become a novel oral treatment option for PsA, addressing the need for safe and effective therapies.
Alumis' A-005 Shows Promise in Phase 1 Trial for CNS Penetration and TYK2 Inhibition
• Alumis' A-005, a selective TYK2 inhibitor, demonstrates successful blood-brain barrier penetration in a Phase 1 trial with healthy subjects.
• The trial confirms A-005's safety, tolerability, and favorable pharmacokinetics, showing significant drug exposure in the cerebral spinal fluid.
• A-005 achieves maximal TYK2 inhibition in the periphery, with drug levels in CSF comparable to or exceeding those in plasma.
• Alumis plans to advance A-005 to a Phase 2 clinical trial for multiple sclerosis in the second half of 2025.
Dermatology Advances: Approvals, Trial Results, and New Guidelines Emerge
• The FDA approved bimekizumab for moderate-to-severe hidradenitis suppurativa, marking the first treatment targeting both IL-17A and IL-17F cytokines.
• Subcutaneous nivolumab's PDUFA date was updated, based on Phase 3 data demonstrating noninferiority to intravenous nivolumab in renal cell carcinoma.
• New clinical guidelines emphasize image-guided superficial radiation therapy for nonmelanoma skin cancers, improving precision in treating basal and squamous cell carcinoma.
• Phase 2b trial results show mRNA-4157 combined with pembrolizumab significantly improves recurrence-free survival in high-risk stage III/IV melanoma patients.
Alumis' Oral TYK2 Inhibitor ESK-001 Shows Sustained Efficacy in Psoriasis Phase 2 Extension
• Alumis Inc. announced positive 28-week data from the open-label extension of its Phase 2 STRIDE trial of ESK-001 for moderate-to-severe plaque psoriasis.
• The data showed that 93% of patients on the 40 mg twice-daily dose achieved PASI 75, demonstrating sustained efficacy over time.
• ESK-001 continued to exhibit a favorable safety profile, with most treatment-emergent adverse events being mild to moderate.
• Alumis expects to report full 52-week OLE data in the first half of 2025 and is advancing ESK-001 in the Phase 3 ONWARD clinical program.
Drug Development Updates
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