Athersys Inc. (NASDAQ:ATHX) has announced that the FDA has granted its MultiStem® cell therapy a Regenerative Medicine Advanced Therapy Designation to treat acute respiratory distress syndrome.
Athersys receive RMAT for MultiStem® in ARDS
The Regenerative medicine Advanced Therapy designation is very important as it enables the company to work closely with the regulatory agency and receive guidance on accelerating a product’s development. This includes getting advice on the generation of data needed to support the approval of the product efficiently. The RMAT designation opens the door for scheduling a Type B meeting with the agency to discuss various strategic development plans that include accelerating product development for commercialization supporting previous review or expedited approval.
The company received the ARDS RMAT designation and the previously issued Fast Track designation that the FDA awarded in May last year. Currently, MultiStem® is the only ARDS cell therapy program with both RMAT and Fast Track designation from the US FDA. The company’s Japanese partner HELIOS K.K expects to complete enrollment in the orphan designated ARDS (ONE-BRIDGE) clinical trial at the end of the year.
MultiStem® showing promise in ARDS patients
Dr. Manal Morsy, the company’s SVP and Global Regulatory Affairs Head, said that they are pleased to receive a second RMAT designation for the MultiStem® program. He added that they have had highly efficient and close interactions with the FDA on the RMAT-designated ischemic stroke program. Morsy said that they are looking forward to enjoying similar advantages and benefits of the accelerated program for Regenerative Medicine therapies for Serious Conditions such as ARDS.
Athersys has carried extensive studies in assessing MultiStem cell therapy as a potential pulmonary distress treatment. Recently the company completes an exploratory phase 1/2 clinical study (the MUST-ARDS study) for ARDS treatment. Subjects were randomized in a double-blind, placebo-controlled study and monitored for 28 days. There was lower mortality in patients that received MultiStem®, and they spent a few days on ventilator and ICU. There was also reported a high quality of life post-ARDS after a year.