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

Allogeneic Mesenchymal Stem Cells for Frontline Workers to Provide Immune Support Against COVID-19

HOUSTON--(BUSINESS WIRE)--Hope Biosciences, a clinical stage biotechnology company focused on developing cell-based therapeutics for acute and chronic disease, today 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.

About Hope Biosciences

Hope Biosciences is a clinical stage biotechnology company focused on developing novel cell-based therapeutics for acute and chronic injury and disease. Hope Bio’s core technology lies in stem cell culture and banking. Mesenchymal stem cells are isolated from approximately one tablespoon of fat tissue, purified, and cultured with Hope Bio’s proprietary culture media, HB-101. HB-adMSCs are expanded to multiple passages and released at Passage 4 for therapeutic use. HB-adMSCs have already been used as a safe and effective treatment in a Phase I/IIa clinical trial for Rheumatoid Arthritis and Expanded Access INDs for Parkinson’s disease, Cerebral Palsy, Spinal Cord Injury, Pancreatic Cancer, and Thrombotic Thrombocytopenic Purpura.

This study is fully funded by the Hope Biosciences Stem Cell Research Foundation. Hope Biosciences Stem Cell Research Foundation is administered through the Greater Houston Community Foundation (GHCF). As one of the leading philanthropic grant makers, GHCF is proud to partner with donors to create a meaningful and long-lasting impact in our community.

Want to help fund the study? Visit Hope Biosciences Stem Cell Research Foundation.