Atopic Dermatitis pipeline: IND Application Cleared by FDA for Novel Monoclonal Antibody OX40 Antagonist
Early proof-of-concept phase 1a data from the trial is anticipated in the third quarter of 2025.
A phase 1 trial for a new potential treatment for atopic dermatitis (AD) is expected to begin this year.
Astria Therapeutics, Inc. announced in December 2024 that the US Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for STAR-0310, a monoclonal antibody OX40 antagonist under development for AD, according to a company news release.
Astria expects to initiate a Phase 1a trial of STAR-0310 in healthy volunteers in the first quarter of 2025.
According to Astria Therapeutics, STAR-0310 has been engineered with a high-affinity, high-potency design coupled with low antibody-dependent cellular cytotoxicity (ADCC). These features may enable an expanded therapeutic window, potentially allowing for infrequent dosing (as few as every six months) and disease-modifying effects.
“We are pleased with the FDA’s acceptance of our IND application for STAR-0310 and the progress it represents for the program,” said Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics. “We are very excited about the potential for the OX40 mechanism. With the goal of creating the overall best OX40 program, we intentionally have designed STAR-0310 to capitalize on the learnings of OX40 receptor and OX40 ligand programs. STAR-0310's high affinity and high potency in conjunction with low ADCC has the potential to enable a wider therapeutic window, and additionally, STAR-0310 has the potential to be dosed as infrequently as every six months due to its long half-life and potential for disease modification.”
Early proof-of-concept data from the trial is anticipated in the third quarter of 2025. Proof-of-concept results in patients with AD are projected for the second quarter of 2026.
Reference
- Astria Therapeutics Announces FDA Clearance of IND Application for STAR-0310, a Monoclonal Antibody OX40 Antagonist for the Treatment of Atopic Dermatitis. December 10, 2024. Accessed January 15, 2025. https://ir.astriatx.com/news-releases/news-release-details/astria-therapeutics-announces-fda-clearance-ind-application-0
