Let’s face it, COVID-19 isn’t going away anytime soon. While we have nailed many Big Board COVID-19 plays like Moderna, Inovio Pharmaceuticals, and Sorrento Therapeutics, the easy money in those names has already been made. Now, our attention is focused on OTC plays that have not seen the big runs yet. One name in particular that we like now is RVVTF, Revive Therapeutics.
Here is what’s exciting about RVVTF.
HOW MANY COMPANIES FOR UNDER $1 ARE CURRENTLY AT PHASE 3 FOR TESTING FOR COVID-19 TREATMENT?
HOW MANY COMPANIES ARE APPROVED FOR TESTING AT PHASE 3 FOR COVID-19?
HOW MANY PHASE 3 COVID-19 TESTING COMPANIES WERE FAST TRACKED BY FDA?
RVVTF meets all 3 criteria. In this article, we take a look at the science behind RVVTF and why this COVID-19 is a cheap exposure to the biggest pandemic of the 21st century.
First up, here’s a little background info for those not familiar with RVVTF. Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy, and Rare Pediatric Disease designations.
Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.
Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation.
The latest news from RVVTF is that the Company’s expanded access protocol for compassionate use of Bucillamine in the treatment of COVID-19 received approval from the independent Institutional Review Board. The EAP for compassionate use is a multi-center, open-label study of Bucillamine in hospitalized patients with severe COVID-19 and is being done to complement the Company’s Phase 3 COVID-19 study in the U.S. Revive expects to have patients enrolled in the United States this month.
Physicians Now Have Access To Bucillamine For Compassionate Use
The EAP for compassionate use provides physicians with access to Bucillamine under Revive’s existing Investigational New Drug application for COVID-19. According to the FDA, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
The expanded access study is titled, “Multi-Center, Open-Label, Expanded Access Study of Bucillamine in Hospitalized Patients with Severe COVID-19 (EA-ARISE)”. Patients will receive Bucillamine 200 mg orally, 3 times a day (TID), for up to 14 days. The objective is to monitor the safety and efficacy of Bucillamine (600 mg/day) and any clinical symptoms when administered up to 14 days in hospitalized patients with severe COVID-19. Following the completion of the treatment course, follow up safety assessments will be performed by a study nurse 14 and 42 days following the end of treatment.
The Science Behind Bucillamine
Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells. N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione.
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV-2 infection in the lungs and attenuate the clinical course of COVID-19.
FDA Support For RVVTF
FDA’s support in advising Revive to move directly into a Phase 3 confirmatory trial provides an acknowledgment for the potential of Bucillamine in the treatment of COVID-19. Entering into a Phase 3 study is a major milestone for RVVTF.
The FDA has provided valuable guidance to RVVTF on study design and outcome measures for the Phase 3 study. Importantly, the FDA agreed that Revive could rely on its data included in its previous IND with Bucillamine for gout to support the COVID-19 Phase 3 study and, therefore, the Company did not have to perform any Phase 1 or Phase 2 clinical studies.
Revive expects to engage up to 10 clinical trial sites in the U.S. and open the Phase 3 clinical trial for patient screening in Q3-2020. The Company is finalizing vendor agreements in the project management, medical monitoring, data management, and clinical packaging for the trials. In addition, Revive and its clinical trial partners will be evaluating potential U.S. clinical sites and clinical investigators in major COVID-19 affected U.S. states, such as Florida, California, Arizona, and Texas.
Phase 3 Confirmatory Clinical Study
The Phase 3 confirmatory clinical 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 that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo.
The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization.
Efficacy will be assessed by comparison of clinical outcome (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo.
Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.
An interim analysis will be performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for a total of 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo.
Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping, or changes to the conduct of the study based on the interim analysis reports.
RVVTF Bottom Line
RVVTF is trading with a market cap of just $42 million and has been approved by the FDA for Phase 3 COVID-19 treatment. We know of no other biotech that has advanced this far with the FDA and trades at such a low valuation. If RVVTF was listed on the Big Board, it would easily have a multi-billion-dollar market cap.
We see two possible scenarios playing out. One is RVVTF signing a joint venture with Big Pharma to advance its Phase trial. Pfizer is one name that we have been hearing rumors about.
The second is the FDA meets next month to discuss all COVID-19 phase 3 trials. RVVTF will be on that list. Could RVVTF also make the list for Operation Warp Speed Funding? The company certainly qualifies.
Smart investors shouldn’t wait around to jump on the RVVTF train. This is perhaps the best risk/reward setup we have seen all year.
As always, good luck to all (except the shorts)!
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Disclosure: We have no position in OTCMKTS:RVVTF or any of the securities mentioned. We wrote this article ourselves and it expresses our own opinions. We are not receiving compensation for it. We have no business relationship with any company whose stock is mentioned in this article. Insider Financial is not an investment advisor and does not provide investment advice. Always do your own research and make your own investment decisions. This article is not a solicitation or recommendation to buy, sell, or hold securities. This article is meant for informational and educational purposes only and does not provide investment advice.