Candidate: MultiStem® for acute respiratory distress syndrome (ARDS)
Type: Adult-derived “off-the-shelf” therapy under development for several neurological and cardiovascular diseases, as well as inflammatory, immune and related disorders. Developed from Multipotent Adult Progenitor Cells (MAPC®) obtained from the bone marrow of healthy, consenting adult donors.
Status: Athersys on May 5 said it began patient enrollment at University Hospital’s Cleveland Medical Center for the MultiStem® Administration for COVID-19 Induced Acute Respiratory Distress Syndrome (MACOVIA). The pivotal Phase II/III study is designed to assess the safety and efficacy of MultiStem® therapy in subjects with moderate to severe ARDS induced by COVID-19. Approximately 400 participants are to be enrolled. The primary efficacy endpoint for the MACOVIA study will compare the number of ventilator-free days through day 28 among MultiStem and placebo treatment groups.
Athersys Founder, Chairman, and CEO Gil Van Bokkelen, PhD, told Ed Henry on his Fox News Channel program “America’s Newsroom” April 1 that the company was in active talks with the FDA about the design and implementation of a Phase III study of MultiStem “that will involve several hundred patients, that will be focused specifically on COVID-19 patients that are experiencing [ARDS].”
In March, Van Bokkelen told GEN the company was planning to launch the Phase III trial “as soon as possible.” The company has won the Biomedical Advanced Research and Development Authority (BARDA)’s designation as a “Highly Relevant” program for COVID-19 based on earlier positive results for MultiStem in ARDS, plus the FDA’s Fast Track designation for the MultiStem clinical program in ARDS—the only Fast Track designation for an ARDS treatment.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: