Medical Mushrooms Showing Potential For Treating COVID Symptoms

Revive Therapeutics Ltd. (OTCQB: RVVTF) (CSE: RVV) gave an update last week on the company’s U.S. Food & Drug Administration (FDA) Phase 3 clinical trial  (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.

Following Revive receiving positive comments from the FDA in regards to the company’s request to determine and agree on the Study’s potential new primary efficacy endpoints and the company’s submission of a Data Access Plan (“DAP”) to the FDA, the FDA has accepted the DAP to allow for the unblinding of the pre-dose selection data. The company will now proceed to unblind the pre-dose selection data to potentially support the amended Study protocol with the new primary efficacy endpoints. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization.

Despite the pandemic seemingly waning, the company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant, there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations. Revive made sure to note that it is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

Medical Mushrooms

According to a study, medicinal mushrooms have documented effects on different diseases, including infections and inflammatory disorders. “The related Basidiomycota Agaricus blazei Murill (AbM), Hericium erinaceus (HE), and Grifola frondosa (GF) have been shown to exert antimicrobial activity against viral agents, Gram‐positive and Gram‐negative bacteria, and parasites in vitro and in vivo. Since the mechanism is immunomodulatory and not antibiotical, the mushrooms should be active against multi‐drug resistant microbes as well. Moreover, since these Basidiomycota also have anti‐inflammatory properties, they may be suited for the treatment of the severe lung inflammation that often follows COVID‐19 infection.”
“An AbM‐based mushroom extract (Andosan), also containing HE and GF, has been shown to significantly reduce bacteraemia and increase survival in mice with pneumococcal sepsis, and to improve symptoms and quality of life in IBD patients via an anti‐inflammatory effect. Hence, such mushroom extracts could have prophylactic or therapeutic effect against the pneumonic superinfection and severe lung inflammation that often complicates COVID‐19 infection. Here, we review antimicrobial and anti‐inflammatory properties of AbM, HE and GF mushrooms, which could be used for the battle against COVID‐19.”

The Center for East-West Medicine, at the University of California Los Angeles (UCLA) applied to the US Food and Drug Administration (FDA) in April 2020 for approval to conduct 2 randomized phase 1 trials. According to the JAMA Network, the double-blind, placebo-controlled studies would evaluate the safety and feasibility of treating mild to moderate COVID-19 with either medicinal mushrooms, which have a long history as natural therapeutics for pulmonary disease, or a Chinese herb formulation that’s widely used there as a COVID-19 remedy. JAMA reported that the FDA ultimately sanctioned the MACH-19 (Mushrooms and Chinese Herbs for COVID-19) trials, which are now underway at UCLA and UCSD and are supported by the Krupp Endowed Fund. Meanwhile, a third MACH-19 trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.

“Researchers are currently conducting in vitro and animal studies with natural products to evaluate direct antiviral activity or to address COVID-19 sequelae,” D. Craig Hopp, PhD, deputy director of the Division of Extramural Research at the National Center for Complementary and Integrative Health (NCCIH), said in an interview. But the MACH-19 treatment trials are unique, he noted, because they’re evaluating natural products among humans with acute SARS-CoV-2 infection.”

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