Equillum Inc. (NASDAQ:EQ) has announced the completion of an FDA pre-investigational New Drug (IND) meeting under the Coronavirus Treatment Acceleration Program (CTAP).
Positive FDA feedback for itolizumab in treating COVID-19 patients
The company, which is developing itolizumab (EQ001) to treat inflammatory and autoimmune disorders, received positive feedback from the FDA. The feedback supports its clinical development plans for evaluating EQ001 as a treatment for patients hospitalized with COVID-19. Following the FDA’s positive response, the company is planning to finalize the protocol and expect IND application submission by October. This is in readiness to commence a global third phase, double-blind, randomized placebo-controlled clinical study in Q4 2020.
Equally, the company expects to commence formal applications for funding support to government agencies for the clinical study. Most importantly, the FDA feedback suggested that should the proposed clinical study meet the key primary and secondary endpoints; it will be adequate to support a biologic Licence Application.
FDA feedback clears a regulatory pathway for Equillium for EQ001
Bruce Steel, the CEO of Equillium, said that the FDA feedback was a huge milestone for the company in the execution of its clinical development program for EQ001 in the treatment of hospitalized COVID-19 patients. Steel added that the proprietary immune-modulating mechanism of EQ001 that down-regulates cytokine cascade and data from previous human trials supports the company’s hypothesis that EQ001 could address immune-inflammatory problems in COVID-19 patients. Further, he added that the FDA guidance offers the company a clear regulatory pathway, and they are committed to accelerating the process and file IND to commence the study in Q4 2020.
Normally a pre-INDA meeting offers a communication opportunity between the agency and the sponsor to deliberate on the IND development plan. This also helps in obtaining FDA guidance for purposes of clinical studies for a company’s drug candidate. The FDA created CTAP to act as an emergency program for assessing potential COVID-19 therapies and has been designed to use all available methods to accelerate treatment to patients as soon as possible.