Hope Biosciences Receives Second FDA Clearance for a Phase II Clinical Trial for Protection Against COVID-19

Hope Biosciences announced that FDA has approved a Phase II clinical trial evaluating the safety and efficacy of Hope Biosciences’ allogeneic, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19.

During this pandemic, there are currently no approved therapies available to support immunity against the Coronavirus disease. Hope Biosciences’ proprietary core technology delivers high-quality, fully characterized, fresh mesenchymal stem cells, on-demand. MSCs are well-known for their immunomodulatory and regenerative potential. In a recent Phase I/II clinical trial for Rheumatoid Arthritis, results appeared to show that HB-adMSCs were safe and effective in attenuating systemic inflammation. “It is our expectation that providing HB-adMSC therapy will boost the immune system, especially in cases of individuals at high-risk of developing COVID-19. A healthy immune system is better able to defend against infectious agents like SARS-CoV-2 and decreases the chance a patient will become critically ill. This not only helps keep people healthy, but it decreases the tremendous burden already on a stressed healthcare system. With this treatment, we hope to build a line of defense for our most vulnerable,” said Donna Chang, President and CEO of Hope Biosciences.

This Phase II study is a randomized, placebo-controlled, double-blind, single center study that is expected to enroll 100 frontline healthcare workers and first responders. The study’s primary objective is to determine the efficacy of HB-adMSCs to provide immune support against COVID-19. Participants will be randomly sorted into one of four groups, placebo, 50 million cells/dose, 100 million cells/dose, or 200 million cells/dose. HB-adMSCs or placebo will be administered intravenously for a total of 5 infusions over a 14-week period. Assessments will be performed prior to each infusion and at 26 weeks to end the study.

This is the second of three New Drug Applications (INDs), related to COVID-19, that Hope Biosciences has filed with FDA. “It is our intention for both our first trial (an open-label, autologous study) and this newly approved trial, to run in parallel. The opportunity to analyze data for parallel studies amplifies the impact of these trials. This data will help us understand the effectiveness of HB-adMSCs to protect against COVID-19 and if there may be a dose dependent response,” said Donna Chang.