With favorable data from the phase III trial testing izokibep, a small protein therapeutic designed to inhibit IL-17A, in hidradenitis suppurativa (HS), Acelyrin Inc. CEO Mina Kim said the firm will “look at all the options and do what’s best for the program.” The phase III trial hit its primary endpoint of Hidradenitis Suppurativa Clinical Response 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.
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 for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Daiichi Sankyo, Cybin, Galderma, Insignis, Kyverna and Mabwell.
Data from an interim analysis have convinced Syros Pharmaceuticals Inc. to stop enrollment in its phase II study of treating newly diagnosed acute myeloid leukemia (AML) and retinoid alpha receptor agonist gene overexpression. Analysts seemed unconcerned about the repercussions for Syros’ phase III study in myelodysplastic syndrome.
Aiming to offer an advantage over Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), dermatology-focused Galderma Holding SA won clearance from the U.S. FDA for Nemluvio (nemolizumab) as a prefilled pen providing a subcutaneous injection to treat adults with prurigo nodularis (PN).
Visen Pharmaceuticals Co. Ltd.’s palopegteriparatide met both primary and secondary endpoints in the phase III Pathway trial conducted in China in adults with chronic hypoparathyroidism, according to top-line data. In the 26-week randomized, double-blind, placebo-controlled Pathway trial, 77.6% of patients treated with palopegteriparatide achieved the primary multicomponent endpoint compared to 0% for placebo.