Revive Therapeutics (RVV.V) is a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders. The company offers cannabinoid pharmaceutical portfolio that focuses on rare inflammatory diseases. It is developing Bucillamine, which is in Phase 3 clinical study for the treatment of infectious diseases, including influenza and COVID-19.
Today, the Company announced an update on the Type C meeting written responses received by the Company from the U.S. Food & Drug Administration (“FDA”) for the evaluation of a proposed clinical study of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for Long COVID.
The FDA has recommended that the evaluation of Bucillamine for Long COVID be submitted as a new Investigational New Drug (“IND”) application and may cross-reference applicable sections from the Company’s current IND that evaluated the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19 in a Phase 3 clinical trial. In addition, the FDA provided valuable feedback on the appropriate design, study population, and safety and efficacy measures for assessing a therapeutic benefit in patients with Long COVID.
“We are pleased with the FDA’s recommendations for our proposed clinical study, which provides a pathway for the clinical development of Bucillamine as a potential treatment for Long COVID,” said Michael Frank, CEO of Revive. “We aim to finalize the clinical study protocol and submit a new IND, which will cross reference our current IND to obtain FDA approval to proceed with the clinical trial for Long COVID.”
Currently, the Company is exploring the use of Bucillamine as a potential treatment for Long COVID. The Company is advancing the clinical development of Bucillamine by leveraging the published research and data from its previous Phase 3 clinical trial and aims to complete the regulatory and clinical package that includes a proposed clinical study for Long COVID, incorporating the recommendations from the FDA from the Type C meeting.
On July 6, 2023, the Company announced the results of its Phase 3 clinical trial evaluating the safety and efficacy of oral Bucillamine in patients with mild to moderate COVID-19. Under the Phase 3 clinical trial primary endpoint, the proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization, there were no deaths and four hospitalizations, of which three were from the placebo arm and one from the Bucillamine low dose group (300mg/day). No hospitalizations occurred in the Bucillamine large dose group (600mg/day). The Company evaluated certain endpoints, including the COVID-19 clinical symptoms data (i.e. cough, fever, heart rate, and oxygen saturation). Based on preliminary analyses, the data demonstrated that for patients with oxygen saturation <96% at baseline, Bucillamine had a 29.1% improvement over placebo in time to normal oxygen saturation (SpO2). Additional Phase 3 clinical trial data analyses may suggest Bucillamine’s potential for Long COVID.
The stock is up 25% at time of writing on today’s news.
The stock remains range bound. In recent days, the stock has tested the very lower limits of this range at $0.02. These levels are previous all time record lows for the stock. The stock needs to see a close back above the $0.025 level to get back within the range and eventually make a run towards the $0.04 zone.
