Astria Therapeutics' STAR-0310 For Treating Atopic Dermatitis Receives FDA Investigational New Drug Approval

Astria Therapeutics, Inc. is a biopharmaceutical company dedicated to developing innovative therapies for allergic and immunologic conditions. Today, the firm announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for STAR-0310. STAR-0310 is a monoclonal antibody targeting the OX40 receptor and is being developed as a potential treatment for atopic dermatitis (AD) and other related conditions.

The company plans to begin a Phase 1a trial of STAR-0310 in healthy volunteers in the first quarter of 2025, with initial proof-of-concept results expected by the third quarter of 2025. Additionally, proof-of-concept results, specifically in atopic dermatitis patients, are anticipated in the second quarter of 2026.

Chris Morabito, M.D., Chief Medical Officer at Astria Therapeutics, said in a statement, “We are pleased with the FDA’s acceptance of our IND application for STAR-0310 and the progress it represents for the program. We are very excited about the potential for the OX40 mechanism. With the goal of creating the overall best OX40 program, we intentionally designed STAR-0310 to capitalise on the learnings of OX40 receptor and OX40 ligand programs. STAR-0310's high affinity and high potency in conjunction with low ADCC, have the potential to enable a wider therapeutic window. 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.”