Equillium Announces Update on Multi-Cytokine Inhibitors EQ101 & EQ102 in Development for Alopecia Areata and Celiac Disease

EQ101 Phase 2 study in alopecia areata is fully enrolled with topline data expected in Q2 2024

EQ302, an orally delivered multi-cytokine inhibitor of IL-15 & IL-21, will be advanced in place of further clinical development of EQ102 based on EQ302’s optimal delivery and increased potency

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced an update on multi-cytokine programs EQ101 in development for the treatment of alopecia areata, EQ102 in development for the treatment of celiac disease, and EQ302, a new orally delivered multi-cytokine inhibitor.

“We are pleased to have completed enrollment of the EQ101 Phase 2 study in alopecia areata,” said Bruce Steel, chief executive officer at Equillium. “We have enrolled a total of 36 patients in the study, of which 13, or 36 percent, had very severe alopecia areata. These patients are in need of new treatments that may have an improved safety profile compared to recently approved JAK inhibitors. While the study remains ongoing, to date EQ101 has been well tolerated over the 24-week dosing period. We expect to announce top-line data in Q2 2024.”

EQ101 Alopecia Areata Phase 2 Study Baseline Characteristics:

• 36 patients enrolled:
  • 17 male and 19 female; 64% Caucasian
  • Age range of 18 to 60 years (mean age 38.2 years)
• Disease severity of patients at enrollment as defined by Severity of ALopecia Tool (SALT):
  • Mean SALT score of 76
  • 17% Moderate (SALT score 35 to 49)
  • 50% Severe (SALT score 50 to 94)
  • 33% Very Severe (SALT score > 95%)
• 27 patients (75%) had been on previous treatments with 11 of those patients having history of oral treatments (including steroids, minoxidil, methotrexate, mycophenolate mofetil) and one patient having previous treatment with a systemic JAK inhibitor

EQ102 & EQ302

“EQ102 is a first-in-class, bi-specific inhibitor of IL-15 and IL-21, two cytokines central to T and B cell activity, that exhibit biological synergy driving aggressive inflammatory responses in a number of gastrointestinal and skin diseases, highlighting the importance of dual inhibition,” said Steve Connelly, chief scientific officer at Equillium. “While EQ102 was generally well tolerated and demonstrated pharmacodynamic activity in the SAD/MAD portions of the study, the bioavailability of this initial formulation was lower than expected. Given our recent progress with EQ302, a potential first-in-class, second generation, orally delivered stapled peptide targeting IL-15 and IL-21, we intend to transition away from further developing EQ102, to advance EQ302 towards the clinic for the potential treatment of patients with gastrointestinal and skin diseases. Preclinical and translational data have demonstrated that EQ302 has increased potency compared to EQ102, is both stable and permeable in the gut, and can be further modified for optimal systemic or gut-restricted activity. Based on the superior product profile of EQ302, and the significant clinical and commercial advantages of orally delivered therapies in these disease settings, we believe advancing EQ302 is a better long-term strategy. This development also illustrates the utility and modularity of our multi-cytokine platform in generating novel, first-in-class therapeutic candidates.”

About Equillium

Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways. EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15; currently under evaluation in a Phase 2 proof-of-concept clinical study of patients with alopecia areata being conducted in Australia and New Zealand by Equillium’s Australian subsidiary as the trial sponsor. EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21; currently in pre-clinical development. The multi-cytokine platform: generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. Itolizumab: a monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells; currently under evaluation in a Phase 3 clinical study of patients with acute graft-versus-host disease (aGVHD) and a Phase 1b clinical study of patients with lupus/lupus nephritis. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited and has entered a strategic partnership with Ono Pharmaceutical Co., Ltd., for the development and commercialization of itolizumab under an option and asset purchase agreement.

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” 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 for developing EQ101 and EQ302 and the expected timeline for topline data for the EQ101 Phase 2 study, the plan to advance EQ302 into the clinic, the potential for EQ 302 to be a first-in-class therapeutic candidate, the potential benefits of EQ101 and EQ302, and the belief that advancing EQ302 is a better long-term strategy. 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; whether the advancement of EQ302 will be a better long-term strategy; Equillium’s ability to execute its plans and strategies; the risk that interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; Equillium’s plans and product development, including the initiation and completion of clinical studies and the reporting of data therefrom; changes in the competitive landscape; and uncertainties related to Equillium’s capital requirements. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231221688487/en/