Revive Therapeutics in Phase 3 clinical trial for COVID-19 treatment
27 Janeiro 2021 - 10:13AM
InvestorsHub NewsWire
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
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