Equillium Cleared to Start First-in-Human Trial of EQ504 in Australia
EQ sits 100% above its 52-week low of $0.756.
Summary
Equillium received Australian HREC approval and TGA clearance to begin its Phase 1 trial of EQ504, an oral AhR modulator for ulcerative colitis. The trial design includes once-daily oral doses from 0.1 to 3.0 mg, with Part A five single ascending dose cohorts, Part B three multiple ascending dose cohorts over 10 days, and Part C a food effect crossover cohort. Dosing of healthy volunteers is expected by early November 2026, with proof-of-mechanism data about six months later. The trial also includes GI biopsies to measure target engagement. This is the first concrete regulatory milestone for EQ504 and de-risks the near-term clinical timeline. A Phase 2 proof-of-concept study in ulcerative colitis is planned for the second half of 2027, contingent on Phase 1 data.
Updated with an SEC 8-K filing · What changed
Updates
· SEC 8-K — The 8-K confirms the Phase 1 trial design: once-daily oral doses from 0.1 to 3.0 mg, with Part A five single ascending dose cohorts, Part B three multiple ascending dose cohorts over 10 days, and Part C a food effect crossover cohort.
At the time of this announcement, EQ was trading at $1.51 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $91.9M. The 52-week trading range was $0.76 to $3.54. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.