Revive Therapeutics Ltd (OTCMKTS:RVVTF) received the FDA’s approval to conduct Phase 3 clinical trial for its leading drug candidate Bucillamine to treat patients with mild to moderate coronavirus.
Seeks approval of IRB
Revive Therapeutics will evaluate the drug’s efficacy and safety in treating the patients and applied for IRB (Institutional Review Board) approval for its clinical trial protocol. The company is also discussing with FDA for CUP (compassionate use program) for its drug – Bucillamine in people who comply with coronavirus trial protocol. It will commence enrollment of patients in September 2020.
CEO of Revive Therapeutics, Michael Frank, said the company is accomplishing significant achievement in its Phase 3 clinical study in coronavirus. It provided the Phase 3 clinical trial protocol to North America based company – Advarra. This process allows the company to choose sites in the US for clinical trial and enroll patients at select locations. The company is also in talks with the US FDA to allow the licensed physicians in the US to request the drug under CUP to treat patients diagnosed with coronavirus.
CUP allows the patients in the US to receive treatment using an investigational drug for severe disease. FDA allows the availability of such drugs when alternate options to treat the disease are not available in the market. Granting of CUP will not interfere with the clinical trial of a drug for marketing approval.
Potential to treat SARS-CoV2 infection
Bucillamine has been in use in South Korea and Japan to treat RA (Rheumatoid Arthritis) for over 30 years. It is non-toxic and maintains a consistent safety profile. The drug is effective in curing respiratory viral infections by attenuating the clinical symptoms. In the clinical study, the drug will be investigated to know if it can improve anti-inflammatory activity and glutathione activity to reduce the destructive effects of SARS-CoV2 infection in human lungs.
Signs a pact with AMS
Revive Therapeutics signed an agreement with AMS (Attwill Medical Solutions Sterilflow, which will act as a resource for distribution and clinical packaging of Phase 3 clinical study to investigate the drug’s efficacy and safety in treating patients with mild to moderate coronavirus.