Equillium Receives Australian Regulatory Clearance to Initiate First-in-Human Clinical Trial of EQ504
Globe Newswire•05/10/2026•16:05 ET
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Key Highlights
- ➤Australian HREC and TGA clearance received for EQ504 Phase 1 trial
- ➤Healthy-participant dosing targeted by early November 2026
- ➤Topline Phase 1 proof-of-mechanism data expected approximately six months after initiation
- ➤Phase 1 trial tests safety, PK and PD across 0.1-3.0 mg oral doses
- ➤Placebo-controlled ulcerative colitis proof-of-concept study anticipated in second half of 2027
Expert Statements
Bruce Steel, Chief Executive Officer of Equillium
“We believe receiving Australian regulatory clearance is an important step in executing our development plan for EQ504 and keeps us on track to dose the first participant in the coming weeks.”
Bruce Steel, Chief Executive Officer of Equillium
“The Phase 1 trial is designed to evaluate safety and tolerability, as well as characterize EQ504’s pharmacokinetic and pharmacodynamic profile to assess proof of mechanism.”
Bruce Steel, Chief Executive Officer of Equillium
“Subject to supportive Phase 1 data, 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.”
On track to initiate dosing by early November 2026; topline Phase 1 proof-of-mechanism data anticipated approximately six months following study initiation
Randomized, double-blind, placebo-controlled study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of EQ504 in healthy subjects
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