Hope Bio’s core technology delivers high-quality, fully characterised, fresh mesenchymal stem cells with immunomodulatory and regenerative capabilities
FDA grants approval for Hope Bio’s HB-adMSC clinical trial against COVID-19. (Credit: PIRO4D from Pixabay.)
Hope Biosciences (Hope Bio), a biotechnology firm developing cell-based therapeutics, has secured the second FDA approval for a Phase 2 clinical trial of its allogeneic, adipose-derived mesenchymal stem cells (HB-adMSCs) to offer immune support against COVID-19.
According to the company, no approved therapies are currently available to support the immunity against Coronavirus disease amid its recent outbreak.
Hope Biosciences president and CEO Donna Chang said: “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.”
HB-adMSCs demonstrated safety and effectiveness in attenuating systemic inflammation
Hope Bio has developed a core technology that delivers high-quality, fully characterised, fresh mesenchymal stem cells (MSC), with immunomodulatory and regenerative capabilities.
The company said that a recent Phase 1/2 clinical trial for Rheumatoid Arthritis showed that HB-adMSCs are safe and effective in attenuating systemic inflammation.
FDA has approved the randomised, placebo-controlled, double-blind, single centre Phase 2 study, aimed at determining the efficacy of HB-adMSCs to provide immune support against COVID-19.
The study will enrol 100 frontline healthcare workers and first responders, and the enrolled participants will be randomly sorted into one of four groups, including placebo, 50million cells/dose, 100million cells/dose, or 200 million cells/dose.
The study marks Hope Bio’s second of three New Drug Applications (INDs) to be filed with FDA, related to COVID-19.
Chang added: “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 analyse 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.”