Equillium Receives Australian Regulatory Clearance to Initiate First-in-Human Clinical Trial of EQ504
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
LA JOLLA, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) -- Equillium, Inc. (Nasdaq: EQ), a biotechnology innovator developing novel therapies to treat severe autoimmune and inflammatory disorders, today announced that the Company has received Human Research Ethics Committee (HREC) approval and clearance from the Therapeutic Goods Administration (TGA) in Australia under the Clinical Trial Notification (CTN) scheme for its Phase 1 clinical trial of EQ504. The Company expects to begin dosing healthy participants by early November 2026.
“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,” said 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. 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.”
As a potent and selective AhR modulator, EQ504 can affect both immune cell responses and barrier restoration. Together, these attributes are particularly important in diseases such as ulcerative colitis, where reducing inflammation and improving and maintaining mucosal healing are critical to achieving meaningful outcomes for patients.
About the Phase 1 Trial
The Phase 1 trial is a randomized, double-blinded, placebo-controlled, single-center study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EQ504 in healthy participants, exploring once-daily oral doses ranging from 0.1-3.0 mg. The trial is structured into three distinct parts:
- Part A - Single Ascending Dose (SAD): Evaluates escalating, once-daily oral doses of EQ504 across five (5) sequential cohorts of healthy participants to determine initial safety parameters and PK.
- Part B - Multiple Ascending Dose (MAD): Evaluates multiple escalating oral doses across three (3) cohorts, in healthy participants receiving once-daily dosing for ten (10) days to assess steady-state PK, safety, and cumulative tolerability. In addition to systemic plasma exposure and to validate the drug's localized mechanism of action, the study protocol incorporates gastrointestinal (GI) mucosal biopsies to be collected longitudinally during the study. A primary pharmacodynamic focus of these biopsies will include the assessment of key tissue-specific biomarkers, including Cytochrome P450 1A1 (CYP1A1) expression. These mechanistic tissue data are designed to confirm localized biological activity and provide target validation ahead of the Phase 2 proof-of-concept study.
- Part C - Food Effect Cohort: A dedicated crossover cohort to evaluate the impact of a high-fat meal on the bioavailability and systemic exposure of a single oral dose of EQ504.
About EQ504
EQ504 is an investigational potent and selective aryl hydrocarbon receptor (AhR) modulator with a multi-modal, non-immunosuppressive mechanism of action designed to be complementary to other inflammation and immunology agents. AhR is critical to barrier organ tissue physiology and immunology, maintaining barrier function and promoting tissue repair and regeneration, while regulating resident immune cells with anti-inflammatory responses. For ulcerative colitis, EQ504 is formulated as an oral, colon-targeted delayed-release drug product. Equillium is also evaluating the potential of EQ504 for additional indications, including inflammatory lung diseases through inhaled formulations.
About Equillium
Equillium is a biotechnology innovator with a mission to develop highly impactful therapies to treat severe autoimmune and inflammatory disorders.
For more information, visit www.equilliumbio.com.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future”, “potential” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements include, but are not limited to, statements regarding Equillium’s plans and strategies with respect to developing EQ504, including the expected timeline for dosing healthy participants and patients; Equillium’s ability to initiate clinical studies and report data from any clinical studies which may be initiated, or the expected timeline for initiating any such studies or reporting data; the expected timeline for initiating and reporting data from a Phase 1 trial of EQ504; the potential benefits of EQ504; and the importance of the attributes of EQ504 in diseases such as ulcerative colitis. Because such statements are subject to risks and uncertainties, many of which are outside of Equillium’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: Equillium’s ability to execute its plans and strategies; risks related to performing clinical and pre-clinical studies; whether the results from clinical and pre-clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; changes in the competitive landscape; and Equillium’s ability to raise sufficient financing, which may not be available on acceptable terms or at all, to advance EQ504 and fund Equillium’s strategic plans. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website and on Equillium’s website under the heading “Investors.” Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Investor Contact
PJ Kelleher
LifeSci Advisors, LLC
+1-617-430-7579
pkelleher@lifesciadvisors.com
