FDA clears investigational new drug application for STAR-0310 for atopic dermatitis
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- Tremfya (guselkumab) is an interleukin-23 inhibitor.
- The submissions are supported by clinical and pharmacokinetic data from multiple phase 3 studies.
The FDA has cleared the investigational new drug application for STAR-0310 as a potential treatment for atopic dermatitis and other diseases, Astria Therapeutics announced in a press release.
STAR-0310 is part of the OX40 antagonist class of medications which has shown efficacy in treating AD and may do so in other diseases as well, such as in hidradenitis suppurativa.
Emma Guttman-Yassky, MD, PhD, Waldman Professor and System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at Icahn School of Medicine at Mount Sinai and a member of Healio Dermatology’s Peer Perspective Board, told Healio that treatments targeting OX40 are promising.
“I am excited about the potential of OX40/OX40L pathway modulators to change the disease course of AD patients,” Guttman-Yassky, who is not involved in the drug's development, said.
The company plans to initiate a phase 1a trial of STAR-0310 in healthy subjects in the first quarter of 2025 followed by the release of early proof-of-concept results in the third quarter of 2025. According to the press release, the company expects to announce proof-of-concept results for patients with AD in the second quarter of 2026.
“We are pleased with the FDA’s acceptance of our [investigational new drug] application for STAR-0310 and the progress it represents for the program,” Chris Morabito, MD, chief medical officer at Astria Therapeutics, said in the release. “We are very excited about the potential for the OX40 mechanism.”