Astria Therapeutics discloses promising early findings from the initial Phase 1a trial on healthy volunteers of STAR-0310, announced at the European Academy of Dermatology and Venereology event
Astria Therapeutics, Inc. (NASDAQ:ATXS) has announced positive initial results from the Phase 1a trial of its YTE half-life extended monoclonal antibody antagonist, STAR-0310, for the treatment of atopic dermatitis. The results will be presented by Dr. Stephan Weidinger, M.D., Ph.D. at the European Academy of Dermatology and Venereology Congress on September 18 at 16:00 CEST.
The Phase 1a trial is a randomized, double-blind, placebo-controlled single ascending dose trial. Participants were randomized to receive a single subcutaneous dose of STAR-0310 or placebo across four dose cohorts: 150 mg, 300 mg, 600 mg, and 1200 mg.
The trial evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in 32 adults. The interim analysis includes available safety, PK and PD data from all cohorts through the following follow-up windows: Day 168 for Cohort 1 (150 mg), Day 140 for Cohort 2 (300 mg), Day 112 for Cohort 3 (600 mg), and Day 84 for Cohort 4 (1200 mg).
So far, the trial's results suggest a favorable safety and tolerability profile for STAR-0310. No fever or chills were observed, consistent with the preclinical observation that STAR-0310 exhibits low ADCC activity. Moreover, STAR-0310 was well-tolerated with no antibody-dependent cellular cytotoxicity (ADCC)-related side effects.
STAR-0310 demonstrated a best-in-class half-life of up to 68 days, potentially allowing for every six-month administration. The trial's results also suggest that STAR-0310 is modulating a broad spectrum of immune pathways beyond Th-2 for a long duration of effect, as indicated by biomarker results.
The results are not yet available for the highest dose cohort (1200 mg). Astria Therapeutics plans to share an update on plans for STAR-0310's development in the coming months. The Company also plans to discuss the results of the trial at an unspecified future event.
STAR-0310's potential wider therapeutic window could drive differentiated lasting efficacy for people living with atopic dermatitis. The company believes that these positive results mark an important milestone in the development of STAR-0310 as a potential treatment for atopic dermatitis.
