Revive Receives Approval for Bucillamine Trial
Posted by Lori Ann Reese on 08/06/2020 in News
Medical content reviewed by Dr. Joseph Rosado, MD, M.B.A, Chief Medical Officer
Revive Therapeutics Ltd. is based in Toronto, Canada. It is a life sciences company that is focused on research and development for rare disease treatments. The Phase 3 clinical trial will reveal whether Bucillamine is an effective treatment for mild to moderate cases of Covid-19.
Source Web August 2020: Global News Wire
The clinical trial was fast-tracked by the U.S. Food and Drug Administration for obvious reasons. As of August 5th, 2020, there were 4,832,302 reported cases of the Novel Covid-19 Coronavirus in the United States. Currently, the state of California leads with 519,427 reported cases of the coronavirus. Some states have had peak daily infection rates exceed 15,000 new cases.
In the study “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19,” 1,000 patients will be enrolled for a 14-day period. Bucillamine (200mg) TID will be administered along with a beta placebo.
Test results from the study will determine how many patients become hospitalized or recover from the Covid-19 virus. The clinical trial will also evaluate fatality rates for patients with severe Covid-19 viral infections. It will also determine whether Bucillamine treatment reduces reliance on respirators and supplementary oxygen.
One of the most life-threatening symptoms of Covid-19 is that it impairs the body’s ability to hold oxygen in cells. Low oxygenation levels are responsible for the extreme fatigue and breathlessness that many patients experience. For patients who are autoimmune compromised, low oxygenation levels can lead to cardiovascular health complications that can be fatal.
Revive Therapeutics (Canada) Has Special Designation With U.S. FDA
The work on Bucillamine is not the first time the FDA has collaborated with Revive Therapeutics researchers in Canada. The life sciences company has been awarded many regulatory incentives from the FDA. Revive Therapeutics has received Orphan Drug, Fast Track, Breakthrough Therapy, and Rare Pediatric Disease designations from the Food and Drug Administration.
Revive Therapeutics Ltd. recently acquired Psilocin Pharma Corp. The M&A will allow Revive Therapeutics to explore the development of Psilocybin therapies. The current portfolio of clinical work at the life sciences corporation has focused on rare inflammatory diseases and cannabinoid pharmaceuticals.
One of the recent breakthrough accomplishments for Revive Therapeutics was the development of protocols for CBD to treat autoimmune hepatitis (a disease of the liver). Other cannabinoid applications include treatments for ischemis and reperfusion injuries to treat patients after organ transplants.
How Could Bucillamine Help Patients with Covid-19?
Bucillamine (N-mercapto-2-methylpropionyl) has been used in countries like Japan and South Korea for more than thirty years to treat conditions like rheumatoid arthritis. One of the properties of Bucillamine is that it can stimulate N-acetylcysteine (NAC) or glutathione, a powerful antioxidant produced in the body.
What researchers know about Covid-19 is that it is a disease that triggers a severe inflammatory response. Clinical researchers refer to that as a “cytokine storm”. It is when the body essentially overreacts to a viral or bacterial infection as an immune system defense. But the severe inflammatory response can also be life-threatening for some patients.
The Phase 3 clinical trial from Revive Therapeutics may determine if Bucillamine is an effective way to reduce cytokine storms and the dangerous inflammatory response. If it is proven to be effective, the drug could help reduce the severity and duration of the Covid-19 viral infection. A potentially life-saving breakthrough in the global fight against the Novel Covid-19 coronavirus pandemic.