Acelyrin Inc. said the phase III trial of izokibep, a small protein therapeutic designed to inhibit IL-17A, in hidradenitis suppurativa (HS) hit its primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at 12 weeks. At the same time, the Los Angeles-based firm made known a refocused pipeline strategy that prioritizes lonigutamab in thyroid eye disease (TED) and is projected to extend its cash runway. The HS program, because of its size, “is best brought to market by a larger organization with the resources and existing footprint” in such indications. Acelyrin has completed the phase I proof-of-concept portion of the ongoing lonigutamab trial and the dose-ranging phase II portion in TED patients is continuing. The drug is a humanized IgG1 monoclonal antibody targeting the IGF-1 receptor, delivered subcutaneously. Shares (NASDAQ:SLRN) were trading Aug. 14 at $3.85, down 91 cents, or 19%.

Verrica produces positive basal cell data, then stock plunges

Preliminary results from a phase II study of Verrica Pharmaceuticals Inc.’s oncolytic peptide for basal cell carcinoma showed half of the participants saw their lesions in complete histologic clearance with no tumor cells left behind. Those who still had tumors saw them shrink 71%. Every participant that received the treatment had a tumor-size reduction of 86%. Verrica is looking to the first quarter of 2025 for more VP-315 study results. Verrica stock (NASDAQ:VRCA) had risen as high as 23% in pre-market trading following release of the phase II data and the company’s earnings, then reversed itself dramatically at midday Aug. 14 by dropping 29.5% to $3.71 each.

US Fed Circuit: Lower court wrong on Viberzi patents

The U.S. Court of Appeals for the Federal Circuit reinstated patent claims covering Allergan USA Inc.'s bowel treatment drug Viberzi (eluxadoline) yesterday, reversing a lower court that had invalidated the claims for not meeting obviousness-type double patenting or written description requirements. However, the appellate court said the district court “can, and should, address any other grounds of invalidity raised … at trial that are adequately supported by the record.” While Judge Timothy Dyk agreed with the Federal Circuit’s precedential opinion concerning the double-patenting issue, he filed a dissent to its written description ruling, citing what he called “ample expert testimony” that supported the district court’s decision.

Ascentage moves BCL-2 inhibtor lisaftoclax into fourth phase III

China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine (AZA) for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome (MDS). The clearance marks the fourth registrational phase III study for lisaftoclax. The Gloria-4 trial is a multicenter, randomized, double-blind, phase III trial to evaluate the efficacy of lisaftoclax in combination with AZA in newly diagnosed adult patients with higher-risk MDS. Lisaftoclax is a novel, orally administered Bcl-2 selective inhibitor that blocks the antiapoptotic protein Bcl-2 and restores the normal apoptosis process in cancer cells.

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