Equillium Reports Positive Interim Results from Phase 3 Itolizumab Study in Acute Graft-Versus-Host Disease

Equillium, Inc. (Nasdaq: EQ), a biotechnology company in the clinical stage of development, recently disclosed that the Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 3 EQUATOR study. This study is focused on evaluating itolizumab in patients with acute graft-versus-host disease (aGVHD). The IDMC's positive feedback is based on their examination of interim results, which included data from over 100 patients assessed through Day 29 of treatment. The committee did not identify any safety or futility concerns and suggested that the study proceed without any changes.

Bruce Steel, the CEO of Equillium, expressed satisfaction with the interim review results, noting that the IDMC's recommendation supports the continuation of the Phase 3 EQUATOR study as originally planned. The study is being conducted across more than 100 clinical sites globally, and Equillium aims to finish it promptly. Steel highlighted the potential of itolizumab to provide significant benefits to patients afflicted by aGVHD, a condition characterized by high mortality rates and traditionally treated with high-dose corticosteroids. The interim data from the study, along with the IDMC's recommendation, have been shared with Equillium's partner, Ono Pharmaceutical. Ono now has a 90-day window, ending in October 2024, to decide whether to acquire Equillium’s rights to itolizumab for JPY 5 billion, or approximately $35 million, plus potential milestone payments totaling up to $101.4 million.

The Phase 3 EQUATOR study is a double-blind, placebo-controlled, multicenter trial that aims to evaluate the effectiveness and safety of intravenously administered itolizumab compared to a placebo. This is being done as a first-line therapy in around 200 adult and adolescent patients with Grade III-IV aGVHD or Grade II aGVHD with lower gastrointestinal involvement, in conjunction with high doses of corticosteroids, the current standard treatment. The primary endpoint of the study is the complete response rate at Day 29, with key secondary endpoints including the overall response rate at Day 29 and the durability of the complete response rate from Day 29 through Day 99.

According to the study protocol, patients should receive itolizumab within three days of their first high-dose corticosteroids administration. The treatment period lasts from Day 1 to Day 99, with a follow-up period extending from Day 100 to Day 365. Around 200 participants will receive 2 mg/kg of methylprednisolone or an equivalent on Day 1 and will be randomized into one of two treatment groups in a 1:1 ratio. The independent data monitoring committee regularly reviews safety data, and an interim analysis for both futility and efficacy was conducted after approximately 100 subjects had completed their Day 29 assessments.

Itolizumab is a first-in-class anti-CD6 monoclonal antibody that specifically targets the CD6-ALCAM signaling pathway. This pathway is crucial in modulating effector T cells while preserving regulatory T cells essential for maintaining immune balance. The pathway is central to the activity and movement of T cells involved in various immuno-inflammatory diseases.

Equillium is dedicated to understanding immunobiology to develop new therapeutics for severe autoimmune and inflammatory disorders. The company's pipeline includes several novel first-in-class immunomodulatory assets. EQ101 is a tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15, and has shown positive results in a Phase 2 study of patients with alopecia areata. EQ302, an orally administered bi-specific cytokine inhibitor targeting IL-15 and IL-21, is in pre-clinical development. The multi-cytokine platform generates composite peptides that selectively block key cytokines at the shared receptor level, targeting pathogenic cytokine redundancies and synergies while preserving beneficial signaling.

Equillium obtained rights to itolizumab through an exclusive partnership with Biocon Limited and has formed a strategic partnership with Ono Pharmaceutical for the development and commercialization of itolizumab.