Equillium, Inc., a biotechnology company, has recently announced the positive interim results from the 1st two cohorts of its Phase 1b EQUATE clinical study of itolizumab. This open-label and dose-escalation portion of the study had been conducted among patients with aGVHD (acute graft-versus-host disease).
GVHD is a multi-system disorder, which is a common complication of allo-HSCT (allogeneic hematopoietic stem cell transplants), caused when the transplanted immune system recognizes and attacks the recipient’s body. The disease results in high mortality and morbidity, with a 5-year survival of nearly 53% among patients who respond to steroids. The mortality rate is up to 95% in patients who do not respond to steroid treatment.
The company has requested the U.S. FDA to conduct a Pre-IND (Pre-Investigational New Drug) meeting and review its proposal of initiating the global, randomized, controlled itolizumab trial among the hospitalized COVID-19 patients.
In the recent EQUATE study, the company evaluates itolizumab among Grade III & IV aGVHD patients. It is typically comprised of the high dose corticosteroids due to the unavailability of other therapeutics that have been approved for this indication. Across the 1st 2 cohorts of the recent study, 71% of the patients achieved a complete response (CR) by Day 29. Additionally, at the 0.4 mg/kg dose, 2 out of 4 patients achieved a CR, resulting in an overall response (OR) and CR rate of 50%. However, all 3 patients achieved a 100% CR & OR rate in the 2nd cohort. All the patients also achieved a CR within the 1st 15 days of treatment.
Equillium had announced a randomized, open-label, controlled itolizumab trial conducted in India by Biocon Ltd., its partner, in July 2020. The trial demonstrated a significant reduction of the mortality rate over a period of 1 month as compared to the placebo among the COVID-19 patients. The DCGI (Drugs Controller General of India) also has granted approval for the emergency use of itolizumab (ALZUMAb) to treat CRS (cytokine release syndrome) in COVID-19 patients in India.