OncoImmune, Inc. has received a study-may-proceed letter from the FDA for its Phase III clinical trial testing the safety and efficacy of CD24Fc for the treatment of hospitalized COVID-19 patients (SAC-COVID). A cohort of 230 subjects with severe clinical symptoms will be randomized and administered a single dose of CD24Fc (480 mg IV infusion) or placebo and followed for a 14-day period to assess safety and efficacy in clinical improvement. The SAC-COVID trial consists of two interim analyses, respectively, for safety and therapeutic activity, and for therapeutic efficacy. This is a double blind, randomized, multi-center clinical trial.
SARS-CoV-2 causes clinical symptoms by killing cells in the lung and by causing inflammation that further exacerbates clinical symptoms. “In addition to anti-viral therapy, a comprehensive strategy in treating COVID-19 patients should include a non-antiviral approach targeting the tissue injury-induced inflammation”, said Dr. Pan Zheng, Chief Medical Officer and co-founder of OncoImmune. CD24Fc will be tested in combination with the best available therapy. Patients receiving other experimental therapies are welcome to participate in the trial.
“CD24Fc is a first-in-class biologic that fortifies an innate immune checkpoint against excessive inflammation caused by tissue-injuries. We are very excited to launch a global effort to test the clinical efficacy of CD24Fc in speeding up recovery of hospitalized COVID-19 patients”, said Dr. Yang Liu, CEO and co-founder.