Revive Therapeutics (RVV.C) investigational new drug application to the FDA puts them in the ring with COVID-19

drug
06/30/2020

The ongoing COVID-19 drama that’s dragged markets to its knees may almost be over, as finally companies have made some headway and there’s a drug out there that’s been proven to shorten recovery time by four days. It’s called Remdesivir, and you probably can’t afford it.

The drug is going to retail for roughly $520 per vial, or $3,120 per course of treatment, according to the Department of Health and Human Services and Gilead Sciences, which manufactured the drug.

Ain’t that a kick in the head?

That’s the benefit of being first to the party.

So you can either shell out or wait for others to arrive to said party and prices to come down. It’s also pertinent to point out that Remdesivir is neither a cure nor a vaccine, and the party is only getting started.

Revive Therapeutics (RVV.C) is on the way to the party.

They submitted their new investigational new drug (IND) application to the United States Food and Drug Administration for bucillamine, it’s prospective COVID-19 treatment, today.

The IND is specifically geared towards getting the FDA’s nod for their phase 3 confirmatory study, and once the FDA signs off, Revive will commence a randomized, double-blind, placebo-controlled study of Bucillamine in patients suffering from a mild to moderate COVID-19 infection. The ETA for this study is anticipated to be Q3, 2020.

“We are very pleased in achieving this major milestone of filing our IND for a Phase 3 confirmatory study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19, which was based on the recommendation from the U.S. FDA from our pre-IND meeting earlier this year. We are preparing plans for initiating the Phase 3 study upon the IND becoming active by the U.S. FDA and we look forward to advancing Bucillamine as a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally,” said Michael Frank, Revive’s chief executive officer.

Bucillamine is a drug regularly prescribed throughout the past thirty years in Japan and Korea to treat rheumatoid arthritis. The basis for the study is to analyze if Bucillamine can lessen the destructive consequences of SARS-CoV2 infection in the lungs.

There’s nothing particularly unorthodox about the study. It’s going to be called “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19” and it will include up to 800 patients, randomized into three cohorts. The first cohort will receive 100 mg of Bucillamine three times a day, the second cohort will get 200 mg three times a day and the third will get a placebo for up to 14 days.

The aim of the 28-day study is to compare the rates of hospitalization and mortality in patients suffering from mild to moderate COVID-19 receiving the drug when compared to those only getting a placebo. They’re going to be measuring for two specific results: the proportion of patients who remain alive and not hospitalized, and the number of patients who are either dead, or alive and hospitalized.

The efficiency of the study will be scrutinized through a comparison of clinical outcomes (how many people died or went to the hospital), disease severity using the eight-category National Institute of Allergy and Infectious Diseases COVID ordinal scale, supplemental oxygen use, and the disease’s progress between patients getting either a high or low dose of Bucillamine when compared to those getting the placebo.

An independent data and safety monitoring board will follow up after 28 days after randomization. The dosage of Bucillamine that performs better during the study will be selected and patients will then be randomized 2:1 – with the two getting the dose and the one getting placebo.

These specifications may seem dry at first, but they’re necessary, especially if you don’t make six figures a year and get a case of the COVIDs. Having options on the market for treatment will reduce the cost of treatment which will enrich everybody, not just greedy pharmaceutical companies.

—Joseph Morton

Full disclosure: Revive Therapeutics is an equity.guru marketing client.

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