AELIS FARMA | MedPath

Alumis to Present 52-Week Phase 2 Data for Novel TYK2 Inhibitor in Psoriasis at AAD 2025

3 months ago

• 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.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.

Aelis Farma's AEF0117 Fails Phase 2B Trial for Cannabis Use Disorder

9 months ago

• Aelis Farma's AEF0117 did not meet its primary endpoint of reducing cannabis use to one day or less per week in patients with moderate to severe cannabis use disorder (CUD). • The Phase 2B trial also failed to meet secondary endpoints, including complete cessation of marijuana use or reduction to two days or less per week. • Indivior, which had an option to license AEF0117, announced it does not currently expect to exercise this option due to the lack of separation from placebo in the trial. • AEF0117 was well-tolerated, with adverse events similar across treatment groups, including placebo, indicating no significant safety concerns.