Equillium Inc（EQ）资讯与事件EQEquillium Inc

Equillium Doses First Subject in EQ504 Clinical Trial in Australia

Equillium announced that the first subject has been dosed in Australia in its Phase 1 clinical trial of EQ504, an investigational oral, colon-targeted aryl hydrocarbon receptor modulator being developed for the treatment of serious inflammatory diseases. The randomized, double-blind, placebo-controlled, single-center study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of EQ504 in about 70 healthy subjects exploring once-daily oral doses ranging from 0.1-3.0 mg. "Subject to supportive topline Phase 1 data, expected in Q2 2027, we anticipate initiating a placebo-controlled proof-of-concept study in patients with moderately to severely active ulcerative colitis in the second half of 2027," said Bruce Steel, CEO.

Equillium Receives Approval for Phase 1 Clinical Trial in Australia

Equillium announced that the company has received Human Research Ethics Committee, or HREC, approval and clearance from the Therapeutic Goods Administration, or TGA, in Australia under the Clinical Trial Notification, or CTN, scheme for its Phase 1 clinical trial of EQ504. The company expects to begin dosing healthy participants by early November.

Equillium CEO: Significant Progress on EQ504 Towards Clinic

"We continue to make meaningful progress advancing EQ504 toward the clinic," said Bruce Steel, Chief Executive Officer of Equillium. "Our colon-targeted formulated product has been manufactured, and we plan to submit the dossier for our Phase 1 study in Australia imminently. We expect to initiate this study in the fourth quarter of 2026 and report topline data approximately six months thereafter. The study is designed as a conventional randomized, double-blind, placebo-controlled single and multiple ascending dose study (SAD/MAD) in healthy volunteers, focused on safety, tolerability, pharmacokinetics and pharmacodynamics to assess proof of mechanism. Subject to supportive Phase 1 data, we anticipate expeditiously initiating a placebo-controlled study to assess the safety, tolerability, and efficacy of EQ504 in patients with moderately to severely active ulcerative colitis. Key study parameters are intended to leverage other AhR modulator clinical datasets in ulcerative colitis to facilitate an efficient patient proof-of-concept study."