The U.S. Food and Drug Administration (FDA) has cleared Astria Therapeutics Investigational New Drug (IND) application to study STAR-0310 in atopic dermatitis (AD).
STAR-0310 is a monoclonal antibody OX40 antagonist in preclinical development for the treatment of atopic dermatitis.
A Phase 1a trial of STAR-0310 in healthy subjects is expected to initiate in the first quarter of 2025, with early proof-of-concept results expected in the third quarter of 2025. Further, the company anticipates proof-of-concept results in atopic dermatitis patients in the second quarter of 2026.
“We are pleased with the FDA’s acceptance of our IND application for STAR-0310 and the progress it represents for the program,” says Chris Morabito, MD, Chief Medical Officer at Astria Therapeutics, in a news release. “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.”
