Astria Therapeutics' STAR-0310 Receives FDA Clearance for Atopic Dermatitis Trial
Key Insights
Astria Therapeutics (search)' IND application for STAR-0310, a monoclonal antibody OX40 (search) antagonist, has been cleared by the FDA.
A Phase 1a trial of STAR-0310 in healthy subjects is set to begin in Q1 2025, with early results expected in Q3 2025.
STAR-0310 is being developed as a potential treatment for atopic dermatitis (search) and potentially other indications.
Astria Therapeutics (search), Inc. (Nasdaq:ATXS) has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for STAR-0310, a monoclonal antibody OX40 (search) antagonist. This drug is under development as a potential treatment for atopic dermatitis (search) (AD) and possibly other conditions.
Phase 1a Trial Details
The company plans to initiate a Phase 1a trial of STAR-0310 in healthy volunteers in the first quarter of 2025. Early proof-of-concept results from this trial are anticipated in the third quarter of 2025. Furthermore, Astria expects to see proof-of-concept results in atopic dermatitis (search) patients in the second quarter of 2026.
Rationale Behind STAR-0310
According to Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics (search), the company aims to create the best overall OX40 (search) program. STAR-0310 is designed to capitalize on the learnings from previous OX40 receptor and OX40 ligand programs. The high affinity and potency of STAR-0310, combined with low antibody-dependent cellular cytotoxicity (ADCC), could enable a wider therapeutic window. Additionally, its long half-life suggests the potential for infrequent dosing, possibly every six months, and potential disease modification.
Potential Best-in-Class Therapy
Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics (search), stated that the Phase 1a trial is an important opportunity to clinically differentiate STAR-0310's profile. The company believes STAR-0310 has the potential to be a best-in-class therapy due to its efficacy, safety, tolerability, and convenient treatment burden, which could significantly improve the lives of individuals with moderate-to-severe AD.
Trial Design
The Phase 1a trial is a randomized, double-blind, placebo-controlled, single ascending dose study. It aims to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in approximately 40 healthy adult participants.
Preclinical Data
Preclinical data indicate that STAR-0310 has the potential for a best-in-class OX40 (search) inhibitor profile. It exhibits significantly less ADCC compared to rocatinlimab, another OX40 antagonist currently in Phase 3 development for AD. Reduction in ADCC activity may lead to a more favorable safety profile and a wider therapeutic window, potentially driving greater efficacy. STAR-0310 has demonstrated a long mean half-life of 26 days in cynomolgus monkeys, compared to the 10-14 days typically seen with non-half-life extended IgG1 antibodies, and has comparable potency to rocatinlimab.