Equinlium Announces Initiation of Phase 2 Study of EQ101, a First-in-Class Multi-Cytokine Inhibitor of IL-2, IL-9 and IL-15 Targeting Alopecia Areata

Equinlium Announces Initiation of Phase 2 Study of EQ101, a First-in-Class Multi-Cytokine Inhibitor of IL-2, IL-9 and IL-15 Targeting Alopecia Areata

LA JOLLA, Calif.–()–Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapies to treat serious autoimmune and inflammatory disorders with high unmet medical need, announced today that it has initiated an open-label study Phase 2 trial of EQ101 to evaluate efficacy and safety in adult subjects with moderate to severe alopecia areata. The study is expected to enroll approximately 30 subjects at multiple clinical sites in Australia.

This is a proof-of-concept study in adult subjects with at least 35% scalp hair loss due to alopecia areata (AA), where EQ101 will be administered intravenously once weekly for 24 weeks at a dose level of 2 mg/kg, with follow-up for an additional four weeks. The objectives of the study are to evaluate the efficacy, safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) properties of EQ101 in adult subjects with moderate to severe AA.

“We are pleased to announce another important milestone in initiating this proof-of-concept study of EQ101 in alopecia areata and now have our two multi-cytokine inhibitors that we acquired earlier this year in the clinic,” said Bruce Steel, Chief Executive Officer at equillium. “EQ101 is a first-in-class trispecific cytokine inhibitor that selectively targets IL-2, IL-9 and IL-15 at the receptor level, which may provide significant advantages over other treatment approaches, including inhibition by JAK. We recently presented data at the Sixth Annual Dermatology Drug Development Summit describing that EQ101 demonstrated more effective hair growth and suppression of cytotoxic CD8+ T cells than ruxolitinib in a mouse model of immune-mediated hair loss. . We believe this study will benefit from strong enrollment support and look forward to presenting data from this study next year.”

“Alopecia areata is one of the most common autoimmune diseases in men with a two percent lifetime risk. Despite the significant psychosocial distress experienced by AA patients, there are still very few treatment options,” said Dr. Rodney Sinclair, Professor of Medicine at the University of Melbourne and Director of Sinclair Dermatology and Principal Investigator of the EQ101 AA study. . “EQ101 specifically targets IL-2, IL-9 and IL-15, which are key cytokines involved in the pathogenesis of AA. The mechanism of action has the potential to produce fewer side effects than recently approved treatments for this disease. I am excited to see the presentation of preclinical and translational data of EQ101 targeting alopecia areata at the World Congress for Hair Research 2022 in Melbourne, Australia later this month, and to lead this Phase 2 study of EQ101 in AA. , of which I hope to have clinical data in 2023”.

An earlier phase 1/2 proof-of-concept study in cutaneous T-cell lymphoma (CTCL) demonstrated that EQ101 was safe and well-tolerated, and treatment resulted in clinically significant improvement in skin scores. EQ101’s differentiated approach to blocking multiple cytokines (IL-2, IL-9, and IL-15) from the common gamma chain receptor known to be upregulated in animal models and human biopsies of alopecia areata may provide a more selective and powerful. treatment approach than direct JAK inhibition, and may position EQ101 as an attractive alternative to JAK inhibitors.

About the EQ101 Phase 2 Study

This is a multicenter, open-label, proof-of-concept phase 2 study in approximately 30 adult subjects between the ages of 18 and 60, with at least 35% scalp hair loss due to alopecia areata (AA). Subjects will be dosed intravenously once weekly for 24 weeks with EQ101 at a dose level of 2 mg/kg, and will be followed for an additional four weeks thereafter. The primary objective of the study is to evaluate the safety and tolerability of EQ101 in subjects with moderate to severe AA over a 24-week treatment period; Secondary objectives will be to assess drug efficacy, pharmacokinetic/pharmacodynamic (PK/PD) properties, and assess changes in patient biomarkers.

About alopecia areata

Alopecia areata (AA) is a common, inflammatory, non-scarring condition that causes hair loss and occurs when the immune system attacks hair follicles on any hair-bearing area of ​​the body, most often on the head and face . The lifetime incidence of AA is estimated to be around two percent worldwide, affecting men and women of all racial and ethnic groups. It has a higher prevalence in children and adolescents, with 40% of cases before the age of 20 and 80% before the age of 40. AA is associated with other immune-mediated or autoimmune disorders, such as thyroiditis, vitiligo, and atopic diseases. Approximately 50% of patients have chronic relapsing-remitting disease that persists for more than 12 months, and approximately 10% to 35% ultimately experience complete loss of scalp hair (alopecia totalis, or AT) or complete loss of scalp and body hair (alopecia universalis, or ES). AA has a significant psychosocial burden that can have a significant negative impact on health-related quality of life and has been associated with depression and anxiety.

There are currently limited treatment options and few countries have approved drugs for the treatment of AA. IL-2, IL-9 and IL-15 are common gamma chain receptor cytokines that are known to be upregulated in animal models and human biopsies of alopecia areata and may provide a selective and potent approach to disease treatment.

About the Multi-Cytokine Platform: EQ101 and EQ102

Our proprietary Multi-Cytokine Platform (MCP) generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level and target pathogenic cytokine redundancies and synergies while preserving nonpathogenic signaling. This approach provides receptor-level inhibition of multiple cytokines and is expected to avoid the broad immunosuppression and off-target safety liabilities that may be associated with other therapeutic classes, such as JAK inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe that identifying the key cytokines for these diseases will allow us to identify and develop personalized treatment strategies for multiple autoimmune and inflammatory diseases.

Current MCP assets include EQ101, a first-class, selective, trispecific inhibitor of IL-2, IL-9, and IL-15, and EQ102, a first-class, selective, bispecific inhibitor of IL-15 and IL-21. .

About Equillium

Equillium is a clinical-stage biotechnology company harnessing a deep understanding of immunobiology to develop novel therapies to treat serious autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel immunomodulatory actives that target immunoinflammatory pathways. Itolizumab, a first-in-class monoclonal antibody that targets the CD6-ALCAM signaling pathway that plays a central role in modulating effector T cells, is currently in a phase 3 study for patients with acute graft disease. against host (aGVHD). ) and is in a phase 1b study for patients with lupus/lupus nephritis. EQ101 is a first-in-class trispecific cytokine inhibitor that selectively targets IL-2, IL-9 and IL-15. Equinlium is currently enrolling patients in a Phase 2 proof-of-concept study of EQ101 for patients with alopecia areata. EQ102 is a bispecific cytokine inhibitor that selectively targets IL-15 and IL-21. Equinlium is currently enrolling patients in a phase 1 study of EQ102, including healthy volunteers and patients with celiac disease.

For more information visit www.equilliumbio.com.

Forward-looking statements

Statements 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”, “prospect”, “future” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are beyond the Company’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential benefits of using our multi-cytokine platform to develop treatments for patients with certain autoimmune and inflammatory diseases, Equillium’s plans to develop EQ101 and EQ102, including the expected timing of key data from the Phase 2 study of EQ101, the potential of any ongoing or planned clinical studies of Equinlium to show safety or efficacy, and Equinlium’s plans and expected time to develop its product candidates and benefits prospects of your product candidates. Risks that contribute to the uncertain nature of forward-looking statements include: uncertainties related to the abilities of the leadership team to perform as expected; Equinlium’s ability to execute its plans and strategies; risks related to conducting clinical studies; the risk that the interim results of a clinical study may not necessarily predict the final results and that one or more of the clinical outcomes may change materially as patient enrollment continues, after more extensive reviews of the data, and as has more patient data; potential delays in the initiation, enrollment, and completion of clinical trials and the reporting of clinical trial data; the risk that studies will not be completed as planned; Equillium’s product development and plans, including initiation and completion of clinical studies and reporting of data from clinical studies; whether the results of the clinical studies will validate and support the safety and efficacy of Equinlium’s product candidates; changes in the competitive landscape; uncertainties related to Equillium’s capital requirements; and having to use cash in different ways or at times than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described in more detail under the heading “Risk Factors” and elsewhere in Equillium’s filings and reports, which can be accessed free of charge by visiting EDGAR on the SEC’s website at http://www.sec.gov and on the Company’s website under the heading “Investors”. Investors should be aware of such risks 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 they are made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date they are made.

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