- Revive Therapeutics (CSE:RVV) has filed its Pre-Investigational New Drug (pre-IND) meeting request with the US Food and Drug Administration
- The request relates to the company’s Bucillamine product as a potential treatment for COVID-19
- Revive is currently finalising a clinical study protocol so it may advance to a Phase 2 clinical study in the US
- The company will rely on its previously submitted pre-IND request to expedite communications
- Revive Therapeutics (RVV) is currently down 4.35 per cent to C$0.11 per share, with a market cap of $6.69 million
Revive Therapeutics (CSE:RVV) has filed its Pre-Investigational New Drug (pre-IND) meeting request with the US Food and Drug Administration (FDA).
The company has previously submitted a pre-IND meeting request to the FDA, which it hopes will expedite communications. Following the meeting, Revive will look to obtain approval to advance to a Phase 2 clinical study of Bucillamine in the US.
Bucillamine has been prescribed as a treatment for rheumatoid arthritis in Japan and South Korea for the last 30 years. However, given its areas of effectiveness, it has the potential to be repurposed as a treatment of acute lung injuries associated with viral infections.
Bucillamine has also been shown to treat oxidative and reperfusion injury in heart and liver tissues. It has a high degree of cell permeability, making it efficient in its delivery.
On March 25 this year, Revive announced that it had enlisted the help of Pharm-Olam, LLC – a company with extensive clinical experience in infectious diseases – as its Contract Research Organization (CRO). Pharm-Olam has, and continues to, assist Revive in its development of the Bucillamine drug.
Michael Frank, CEO of Revive Therapeutics, said he is excited to be moving forward with the clinical investigation regarding Bucillamine.
“We will also seek to expand the clinical investigation of Bucillamine in Asian regions, with a particular interest in Japan and South Korea where Bucillamine has been prescribed for treating arthritis for over 30 years.
“We are in discussion with various contract research organizations in these regions,” he added.
The planned placebo-controlled Phase 2 clinical study of Bucillamine will explore a variety of objectives. Most importantly, it will look at the disease course in patients receiving Bucillamine therapy compared to a placebo.
The study will also evaluate the safety of Bucillamine therapy when administered up to 14 days, and the time to clinical improvement in patients with symptoms.
Revive Therapeutics (RVV) is currently down 4.35 per cent to C$0.11 per share at 2:52pm EST.