Benzinga | Sep 15, 2020 08:21AM EDT

Equillium Announces Completion Of FDA Pre-IND Meeting For Itolizumab

Equillium anticipates filing a U.S. IND for Itolizumab for COVID-19 and initiating a global Phase 3 clinical study in Q4 2020

LA JOLLA, Calif., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced it has completed a pre-Investigational New Drug(IND) meeting with theU.S. Food and Drug Administration(FDA) under theCoronavirus Treatment Acceleration Program(CTAP). The FDA provided positive feedback supporting Equillium's clinical development plans for evaluating itolizumab (EQ001) as a potential treatment for hospitalized patients with COVID-19. With this feedback, Equillium plans on finalizing the protocol and anticipates submitting its U.S. IND application to the FDA in October 2020 in preparation for initiating a global Phase 3, randomized, double-blind, placebo-controlled clinical trial during the fourth quarter of this year. At the same time, Equillium anticipates beginning formal applications to governmental agencies for funding support of the clinical study. Importantly, the FDA indicated that the proposed study, if it meets its primary and key secondary endpoints, may be sufficient for a Biologic License Application (BLA) submission.

"This feedback from the FDA is a significant milestone for Equillium in executing our clinical development program for itolizumab in treating hospitalized patients suffering fromlife-threatening consequences as a result of COVID-19," said Bruce Steel, chief executive officer, Equillium. "We believe itolizumab's novel immune-modulating mechanism, which down regulates the cytokine cascade, and data from prior human clinical trials -- including recent positive interim data from our Phase 1b clinical study in acute graft-versus-host disease and Phase 2 study data in COVID-19 patients reported by our partner Biocon Limited -- support our hypothesis that itolizumab may have promise in addressing immuno-inflammatory complications experienced by COVID-19 patients. This guidance from the FDA provides us a well-defined regulatory pathway and we willcontinue working expeditiously to file our IND with the goal of initiating the study in Q4 2020."

A pre-IND meeting provides an opportunity for an open communication between the sponsor and the FDA to discuss the IND development plan and to obtain the FDA's guidance for clinical trials for the sponsor's drug candidate. The FDA has created CTAP as a special emergency program for possible coronavirus therapies, which is designed to use every available method to move new treatments to patients as quickly as possible, while evaluating safety and effectiveness.