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

By Chris Lange Published Oct 30, 10:36AM EDT

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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.

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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.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.