Novel drug developer Revive Therapeutics Ltd. (CSE: RVV) hit a major milestone this week receiving U.S. Food and Drug Administration approval to begin a Phase 3 trial of its lead drug Bucillamine to treat patients with Covid-19.
On Friday, the Toronto-based company said the confirmatory Phase 3 clinical will be randomized and double-blind to study the safety and efficacy of Bucillamine in treating mild to moderate cases of the infectious disease.
Shares of the firm jumped 68 per cent on the news to $0.40 a share.
While Revive is also developing cannabinoid-based drugs to treat rare inflammatory diseases, the company has been anchored in advancing its Bucillamine coronavirus treatment since March.
Bucillamine is a derivative of the amino acid cysteine, which is found in chicken, eggs and cheese. The company says previous studies have shown the drug helps slow the damage caused by Covid-19 to cells in the lungs of animals and humans.
“The FDA approval of the Phase 3 study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 is a tremendous milestone for Revive and I am very proud of the dedication of our team and partners to bring forward a potential new treatment option for patients with a confirmed diagnosis of Covid-19 globally,” CEO Michael Frank said in a statement.
Revive Therapeutics Announces U.S. FDA Approval of Confirmatory Phase 3 Clinical Trial for Bucillamine in COVID-19 | $RVV #covid19 #healthcare #infectiousdiseases #clinicalstudy #pharma #psilocybin #healthtech #psychedelics #pharmaceutical #lifesciences https://t.co/jrQ8MOr21G pic.twitter.com/yOTIxTg2Om
— Revive Therapeutics (CSE: RVV, US: RVVTF) (@Revive_RVV) July 31, 2020
The new trial will evenly split up to 1,000 patients into three groups, giving each a 100 milligram dose, a 200 milligram dose or a placebo for up to 14 days.
The primary objective is to see whether the patients with Covid-19 receiving the Bucillamine therapy can avoid hospitalization or death compared. The study will observe patients’ response on the 28th day after the drugs have first been administered.
Efficacy for the drug will be assessed by observing whether it can reduce the severity and progression of Covid-19 symptoms, including the lungs’ ability to absorb oxygen.
Revive chief executive Frank said the firm is focused on executing the clinical trial in an “expeditious manner.”
Additionally, an interim analysis will be performed by an independent safety board after 210 patients have been treated and followed up 28 days after the trial begins.
The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized to the selected Bucillamine dose or the placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have finished treatment.
Revive says Bucillamine has a well-known safety profile and has been prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years.
The company has also received FDA orphan drug status for the use of CBD to treat the liver disease autoimmune hepatitis as well as treating tissue damage and injury caused by inadequate blood supply from organ transplants.
Several separate studies have shown promising results that CBD can treat deadly inflammation in patients with Covid-19.
Earlier this year, Revive jumped into the psychedelic space when it acquired Psilocin Pharma Corp. for $2.75 million.
The psychedelic firm is developing six psilocybin-based drugs, which are being targeted for clinical research subject to FDA approval for treating depression, anxiety, bi-polar disorder, bulimia and anorexia nervosa.
Top image via Revive Therapeutics