Health and Healthcare

What This FDA Update Means for Equillium's COVID-19 Study

Chris Lange

Published: October 30, 2020 10:36 am

Equillium Inc. (NASDAQ: EQ) shares jumped on Friday after the company announced a key update from the U.S. Food and Administration (FDA) regarding its late-stage COVID-19 trial.

Specifically, the company received a letter from the FDA that it may begin its Phase 3 Equinox clinical trial evaluating itolizumab in hospitalized COVID-19 patients suffering from acute respiratory distress syndrome.

Equillium plans to start enrolling patients during the fourth quarter of 2020, and initial clinical data is expected mid-year 2021. The FDA has indicated that the trial, if it meets its primary and key secondary endpoints, may be sufficient to support regulatory filing of a Biologic License Application.

The Phase 3 Equinox trial will enroll a total of 800 patients at sites in the United States and abroad, with patients randomized on a one-to-one basis of receiving itolizumab or a placebo.

The primary endpoint of the trial is to evaluate the benefit of itolizumab on recovery in patients hospitalized with COVID-19. Key secondary endpoints include mortality benefit and other measures of clinical improvement.

In July, the Equillium announced that its partner Biocon reported a Phase 2 data from its clinical trial of itolizumab in India. Results demonstrated significantly reduced mortality over one month as compared to placebo in patients hospitalized with COVID-19.

Looking forward, Equillium and Biocon are working closely together on the further development of itolizumab in COVID-19 patients. The duo is also planning to scale up manufacturing to support access to treatment for the greatest possible number of patients worldwide.

Excluding Friday’s move, Equillium stock had outperformed the broad markets with a gain of about 78% year to date. In the past 52 weeks, the share price was up about 89%.

Equillium stock traded up about 12% on Friday, at $6.74 in a 52-week range of $2.20 to $27.05. The consensus price target is $18.75.