Equillium receives Australian clearance to begin Phase 1 trial of EQ504
Equillium Inc. obtained Human Research Ethics Committee and Therapeutic Goods Administration approval in Australia for its Phase 1 study of EQ504, an AhR modulator for ulcerative colitis and other inflammatory diseases. The company plans to start dosing healthy volunteers in early November 2026 and expects topline proof‑of‑mechanism data about six months later. The trial will be randomized, double‑blind, placebo‑controlled and will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics across multiple dose cohorts.
Why it matters
The company says the clearance keeps the development timeline on track and will provide data needed to launch a placebo‑controlled proof‑of‑concept study in ulcerative colitis patients in the second half of 2027.
Key facts
- 1Equillium received HREC and TGA clearance under the Clinical Trial Notification scheme for the Phase 1 trial of EQ504. globenewswire.com
- 2Dosing of healthy participants is expected by early November 2026. globenewswire.com
- 3Topline Phase 1 proof‑of‑mechanism data are anticipated approximately six months after study initiation. globenewswire.com
- 4The trial will evaluate oral doses ranging from 0.1 mg to 3.0 mg in a single‑center, randomized, double‑blind, placebo‑controlled design. globenewswire.com
- 5Part B of the study includes multiple ascending doses over ten days and gastrointestinal mucosal biopsies to assess tissue biomarkers such as CYP1A1 expression. globenewswire.com
Summary written by AlphAI from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.