Aclaris Rips Higher Following FDA Approval Of Coronavirus Study

Shares of micro-cap biopharma Aclaris Therapeutics Inc ACRS were rallying Wednesday after the FDA gave its blessing for the company's investigational new drug application for a potential coronavirus treatment. 

What Happened: The Wayne, Pennsylvania-based company said the FDA allowed its IND application for evaluating ATI-450, its oral investigational MK2 inhibitor compound, in hospitalized patients with COVID-19.

The company said ATI-450 has shown ability to regulate pro-inflammatory cytokines associated with cytokine release syndrome, or CRS.

CRS leads to the release of multiple inflammatory cytokines, which precedes acute respiratory distress syndrome seen in COVID-19 patients, according to the company. 

What's Next: Aclaris said it is supporting an investigator-initiated trial of ATI-450 for CRS in 36 hospitalized patients with COVID-19.

The company also said it will provide funding and clinical drug supply to the University of Kansas Medical Center, the sponsor of the trial.

The study is designed as a Phase 2a study investigating the safety and efficacy of ATI-450 in combination with the standard of care therapy. The primary endpoint is the proportion of subjects who are free from respiratory failure by day 14.

At last check, Aclaris shares were rallying 18.99% to $1.76.

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