New York, June 6, 2024 - PRISM MarketView - Equillium Inc. (Nasdaq: EQ) has announced positive topline data from its Phase 2, single dose, proof-of-concept study of EQ101 in adult patients with alopecia areata (AA), an autoimmune disease that causes hair loss. EQ101 is a novel multi-cytokine inhibitor with a targeted mechanism of action against cytokines IL-2, IL-9 and IL-15, which are key drivers of the pathogenic T cells implicated in AA.
Equillium’s study evaluated the safety, tolerability and efficacy of EQ101, using Severity of Alopecia Tool (SALT) scores, where a score of 100 represents total scalp hair loss and a score of 0 represents no scalp hair loss.
“The results from this Phase 2 proof-of-concept study of EQ101 in alopecia areata patients are very compelling. Placebo rates in this indication across studies have been consistently low – generally less than 10 percent of patients achieve a SALT score of 20 or less. To have 20 percent of patients completing the study reach a SALT score of less than or equal to 20 across all subjects, and 29 percent of moderate and severe patients, is a very encouraging sign of drug activity. With Janus kinase inhibitors currently the only approved therapies to treat alopecia areata, a significant unmet need remains for novel drug mechanisms that are effective and well tolerated; and the targeted multi-cytokine activity of EQ101 represents a welcome approach.”
The study’s principal investigator, Rodney Sinclair, MD, Sinclair Dermatology, Melbourne, Australia
Equillium’s study was a multicenter, open-label, proof-of-concept Phase 2 trial in 36 adult subjects with at least 35% scalp hair loss due to AA. Subjects were 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.
AA is a common 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. It affects approximately 160 million people worldwide and 6.7 million people in the United States.
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; recently announced positive results from a Phase 2 proof-of-concept clinical study of patients with alopecia areata 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 recently completed 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.
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