Revive Therapeutics in Phase 3 clinical trial for COVID-19 treatment

January 27, 2021 -- InvestorsHub NewsWire -- via Imperium Group -- Revive Therapeutics, a biotech company focused on “developing treatments for rare disorders and infectious diseases,” announced that it has received approval to enter a Phase 3 clinical trial for the non-vaccine treatment of COVID-19 through the use of Bucillamine, an anti-inflammatory.

“The FDA approval to proceed to a Phase 3 study to evaluate Bucillamine for patients with mild - moderate COVID-19 is a tremendous milestone for Revive,” CEO Michael Frank said on the company's website. “I am very proud of the dedication of our team and partners to bring forward a possible new treatment option for people with a confirmed diagnosis of COVID-19 globally.”

Revive, which describes itself as a life sciences company, also explores the use of cannabinoid delivery systems and psilocybin for the treatment of substance use disorders and other health conditions.

Entering the Phase 3 study for the use of Bucillamine

Known for its powerful anti-inflammatory and anti-oxidant benefits, Bucillamine has been prescribed for decades in countries like Japan and South Korea.

Revive tested the impact of Bucillamine on gout in 2015 in a Phase 2 FDA study. The results met primary efficacy and safety endpoints for the treatment of gout, however, the project was put on hold to direct more focus towards emerging cannabidiol-based intellectual property and therapeutics.

With COVID-19 causing inflammatory responses in the body, Revive revisited the concept of using Bucillamine as a treatment option, pulling from prior positive data from its 2015 gout study and re-purposing the compound to specifically target the inflammation of the lungs.

The basis of the new clinical study is to analyze whether or not Bucillamine has the potential to lessen the destructive consequences of COVID-19.

Initial trial procedures

According to the FDA, Phase 3 clinical trials include 300 - 3,000 volunteers and can last one to four years. Revive’s study, titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19,” will enroll up to 1,000 patients who will receive one of three randomized and evenly distributed treatments (1:1:1):

Treatment 1 - Bucillamine 100 mg
Treatment 2 - Bucillamine 200 mg
Treatment 3 - placebo

The primary objective is to compare patients receiving the Bucillamine therapy with those receiving the placebo. The primary endpoint will be measured by assessing the number of hospitalizations and deaths among the patients from the time of their first dose through day 28 of treatment.

The development of a useful therapeutic treatment for COVID-19 would be substantial. As a low-market cap, non-vaccine COVID-19 therapeutic company currently undergoing a Phase 3 trial, Revive executives believe the company has strong growth potential as its Bucillamine trial meets safety and efficacy endpoints.

Revive also explores a psilocybin solution for mental illness and other disorders

The company is also entering a space that has seen strong growth in recent years, by prioritizing its focus on developing and acquiring psilocybin/psychedelic assets for the treatment of depression and other conditions.

Headlining these efforts is the company’s sponsored research partnership agreement with the University of Wisconsin-Madison to evaluate novel formulations and drug delivery technology focused on psilocybin-based pharmaceuticals. Under the agreement, the research team will evaluate psilocybin-based formulations and the patented Tannin-Chitosan composite drug delivery technology for psilocybin.

This technology aims to deliver both synthetic and natural extract of psilocybin in a number of ways such as topical gels, creams or ointments, oral or transdermal patches, oral dosages and foams.

Given the company’s proven success in designing and conducting FDA-phase trials including with traditional pharmaceutical drugs such as Bucillamine, Revive continues to push forward with its intellectual property and treatment options in innovative ways.

SOURCE: Imperium Group

Revive Therapeutics (QB) (USOTC:RVVTF)
Historical Stock Chart
From Mar 2024 to Apr 2024