Small cap biotechnology company Athersys (NASDAQ: ATHX) filed a current report to provide updates around its operations including the progress of its COVID-19 and trauma studies. Both studies involve the use of its proprietary stem cell product MultiStem. MultiStem is being developed to treat various neurological, immune, and cardiovascular diseases.
Athersys has been in discussions with the Biomedical Advanced Research and Development Authority (BARDA) as part of the U.S. government’s response to the COVID-19 pandemic. The review concluded that the use of MultiStem for the treatment of acute respiratory distress syndrome (ARDS) was designated as highly relevant by the CoronaWatch task force. According to the World Health Organization (WHO), ADRS is the leading cause of those infected with COVID-19.
FDA authorizes continuation of MultiStem trial for COVID-19 cases
On April 13th, the U.S. Food and Drug Administration (FDA) authorized Athersys to begin a Phase 2/3 study to determine the effectiveness of MultiStem therapy in patients with moderate to severe ARDS due to the novel coronavirus disease. The company plans to open the first clinical sites for the trial later this quarter.
The primary efficacy endpoint will be to measure how many days out of 28 days that the patients are ventilator-free. As many as 400 subjects will be enrolled in the trial which will take place at several pulmonary critical care centers across the U.S.
Senior Medical Director Dr. Eric Jenkins stated, “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.”
Trauma patient trial also gets FDA nod
The following week, on April 15th, Athersys announced that it received FDA authorization to begin a phase two trial of its MultiStem cell therapy for the potential use in trauma patients. The therapy is designed to be an early treatment for injuries that result from severe trauma.
This trial will take place at the University of Texas Health Science Center in Houston. It will enroll approximately 150 severely injured trauma patients after they have been hospitalized, received initial treatment, and have been admitted to the intensive care unit (ICU). The trauma
study is being supported by a grant that was awarded by the Medical Technology Enterprise Consortium.
The combination of the FDA authorizations for the respective trials of MultiStem in the treatment of coronavirus patients and trauma patients made for a very busy week for Athersys. Investors initially applauded the news in bidding the stock up above the $3.00 level, however the stock dropped back down near $2.00 just a few days later. This is not uncommon stock price activity for a small, upstart biotechnology company like Athersys.
Despite the recent ups and downs, the company’s MultiStem seems to hold solid growth potential in the treatment of multiple diseases and medical conditions. More volatility is likely ahead when the company reports its quarterly financial performance on May 13th.