Phase 2 proof-of-concept study evaluating EQ101 efficacy, safety, tolerability and PK/PD in subjects with alopecia areata over 24 weeks of treatment

EQ101 targets IL-2, IL-9, and IL-15, key cytokines known to be upregulated in alopecia areata, and therefore may provide a more selective and potent approach to disease treatment

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that it has initiated a Phase 2 open-label study of EQ101 to assess 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 over 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 major milestone as we initiate this proof-of-concept study of EQ101 in alopecia areata and now have both of our multi-cytokine inhibitors we acquired earlier this year in the clinic,” said Bruce Steel, chief executive officer at Equillium. “EQ101 is a first-in-class, tri-specific cytokine inhibitor selectively targeting IL-2, IL-9 and IL-15 at the receptor level, that may afford significant advantages over other treatment approaches, including JAK inhibition. We recently presented data at the Sixth Annual Dermatology Drug Development Summit outlining that EQ101 demonstrated more effective hair regrowth 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 auto-immune diseases in man with a lifetime risk of two percent. Despite the significant psychosocial distress experienced by patients with AA, 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 for the EQ101 AA study. “EQ101 specifically targets IL-2, IL-9 and IL-15, which are key cytokines implicated 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 pre-clinical 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, from which we hope to have clinical data in 2023.”

A previous 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 meaningful improvement in skin scores. The differentiated approach of EQ101 to block multiple cytokines (IL-2, IL-9 & IL-15) of the common gamma chain receptor that are known to be upregulated in animal models and human biopsies of alopecia areata may provide a more selective and potent approach to treatment than direct JAK inhibition, and may position EQ101 as an attractive alternative to JAK inhibitors.

About the Phase 2 Study of EQ101

This is a multicenter, open-label, proof-of-concept Phase 2 study in approximately 30 adult subjects between 18 and 60 years of age, 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 subsequently followed for an additional four weeks. 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 evaluate drug efficacy, pharmacokinetic/pharmacodynamic (PK/PD) properties, and to assess changes in patient biomarkers.

About Alopecia Areata

Alopecia areata (AA) is a common, inflammatory, non-scarring condition resulting in hair loss that occurs when the immune system attacks hair follicles on any hair-bearing area of the body, most frequently on the head and face. The lifetime incidence of AA is estimated at about two percent globally, affecting men and women of all racial and ethnic groups. It has a higher prevalence in children and adolescents with 40% of cases occurring prior to age 20, and 80% before age 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 persisting 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 AU). 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 cytokines of the common gamma chain receptor 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 Multi-Cytokine Platform: EQ101 & EQ102

Our proprietary Multi-Cytokine Platform (MCP) 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. This approach provides multi-cytokine inhibition at the receptor level and is expected to avoid the broad immuno-suppression 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 identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.

Current MCP assets include EQ101, a first-in-class, selective, tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21.

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 immunomodulatory assets targeting immuno-inflammatory pathways. Itolizumab, a first-in-class monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells, is currently in a Phase 3 study for patients with acute graft-versus-host disease (aGVHD) and is in a Phase 1b study for patients with lupus/lupus nephritis. EQ101 is a first-in-class tri-specific cytokine inhibitor that selectively targets IL-2, IL-9, and IL-15. Equillium is currently enrolling patients in a Phase 2 proof-of-concept study of EQ101 for patients with alopecia areata. EQ102 is a bi-specific cytokine inhibitor that selectively targets IL-15 and IL-21. Equillium is currently enrolling patients in a Phase 1 study of EQ102, including healthy volunteers and celiac disease patients.

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. Because such statements are subject to risks and uncertainties, many of which are outside of 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 for developing EQ101 and EQ102, including the expected timing of presenting topline data from the Phase 2 study of EQ101, the potential for any of Equillium’s ongoing or planned clinical studies to show safety or efficacy, and Equillium’s plans and expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties related to the abilities of the leadership team to perform as expected; Equillium’s ability to execute its plans and strategies; risks related to performing clinical studies; 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; whether the results from clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; changes in the competitive landscape; uncertainties related to Equillium’s capital requirements; and having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. 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 EDGAR on the SEC web site at http://www.sec.gov and on the Company’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.

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