Athersys Inc (NASDAQ: ATHX) is making a run for the top in the market this morning, and for good reason. The stock is up more than 15% after announcing that the FDA has approved the company’s Phase 1 clinical trial in the treatment of COVID-19 patients. Here’s what’s going on:

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ATHX Stock Heads Up On COVID-19 Clinical Trial News

In the press release, Athersys said that the FDA has authorized the initiation of a Phase 2/3 pivotal study to assess the safety and efficacy of MultiStem. The company’s flagship candidate will be given to COVID-19 patients who suffer from moderate to severe acute respiratory distress syndrome, or ARDS.

ARDS is one of the most concerning conditions brought on by COVID-19, ultimately leading to the majority of deaths associated with the illness.

Importantly, ATHX said that the program falls under the current IND for the completed MUST-ARDS study. As a result, no new IND needs to be filed with the FDA, helping to save time and money in the push to get this treatment to coronavirus patients.

In the release, the company said that it will open the first clinical sites for recruitment of this study during the current quarter. The study will be known as MACOVIA (MultiStem Administration for COVID-10 Induced ARDS).

In a statement, Dr. Eric Jenkins, MD, Senior Medical Director and Head of Clinical Operations at ATHX, had the following to offer:

We are grateful for the FDA’s timely review and feedback during our design of this pivotal Phase 2/3 study. With encouraging non-clinical and clinical data, affirmed by the FDA’s Fast Track designation for ARDS, Athersys and its collaborating clinical investigators are highly motivated by the FDA’s authorization that we may proceed with enrollment of the first open-label cohort to evaluate safety. We are in communication with FDA regarding the enrollment of further cohorts to conduct a scientifically rigorous evaluation of MultiStem’s safety and efficacy in the treatment of ARDS due to COVID-19. We believe that MultiStem treatment, by modulating patients’ hyperinflammatory response to highly pathogenic respiratory viruses, including SARS-CoV-2 which causes COVID-19, represents a very promising approach to improving outcomes in patients who suffer the most severe manifestations of these illnesses.

Why This News Is Leading To Such A Dramatic Run

Let’s face it, the coronavirus is a serious issue. The pandemic has led to the closing of schools around the world, social distancing, and much more. In order to fight the pandemic, we need a few things.

These include testing, personal protective gear, and treatments. That’s where Athersys comes in. The company’s MultiStem treatment has already shown efficacy in ARDS among non-coronavirus patients. As such, there’s a strong chance that we will see positive results among patients with ARDS that was caused by COVID-19.

Ultimately, this treatment will be headed into the clinic in the current quarter. As such, we should expect to see results relatively soon. Should these results be positive, ATHX may be the first company to bring a treatment to market. That’s exciting news!

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