Revive Therapeutics Ltd. (CNSX: RVV, OTCMKTS: RVVTF) and most of Merck’s competitors in the race to develop an oral COVID therapeutic displayed poor price performance last Friday. The unexpected news that molnupiravir had reduced hospitalizations by 50% compared to placebo—prompting their Data Monitoring Board to conclude the trial early—sent shockwaves throughout the biotech community. In response, Merck & Co. shares soared +8.37%, adding about $18.5 billion dollars of market cap. Atea Pharmaceuticals, which is developing a drug with a similar mode-of-action to molnupiravir, rose +19.82% as well. But does Merck’s first-out-of-the-gate success mean that efforts by companies such as Revive (Bucillamine) are now futile? Not so fast says this Clinical Trial Manager.
To extract some additional color on the situation, we turned to Biomedical_trader (BT)—the defacto leader of Revive’s growing Reddit forum, and Bioengineer/Clinical Research Associate by trade.
To recap Merck’s surprise success last Friday, the company announced that 7.3% of patients who received molnupiravir were hospitalized through day 29—in accordance with the trial design—had been hospitalized or died. This compared with 14.1% of placebo-treated patients, meaning that molnupiravir reduced the risk of hospitalization or death compared to placebo by approximately 48.2%. Merck was selectively treating at-risk patients for COVID with at least one co-morbidity.
At the recommendation of an independent Data Monitoring Committee—and in consultation with the U.S. Food and Drug Administration (FDA)—the trial was stopped after its scheduled interim analysis at 775 patients, paving the way for Merck to file for Emergency Use Authorization (EUA). Should this application gain acceptance, molnupiravir will be the first oral COVID therapeutic to gain sanction from the FDA.
While Merck gains a decisive first-mover advantage, don’t count its competitors out yet. More than likely, several oral therapeutics will be required to contain the virus, which mutates quickly and will likely develop drug resistance to anti-viral drugs over time. According to Biomedical_trader, “the FDA is definitely going to go for about 2 or 3 of these pills at least.”
In relation to Bucillamine—currently in a Phase 3 to treat mild/moderate COVID against benchmarks of reduced hospitalizations and death—Biomedical_trader believes it has a better-than-even shot of obtaining EUA itself:
Benjamin A. Smith: In your opinion, does Revive have an opportunity to receive EUA and what do you think the chances of that are?
Biomedical_trader: Well, at this next interim analysis (600 patients, expected to be filed shortly) I don’t think there’s too much chance. But, you know, my best guess is that it’s going to take about 700 to 900 patients to show a difference for their drug. And, you know, we know that some of the mechanisms of Bucillamine kind of address some of the things that make certain patients like diabetics and older people at higher risk of developing severe symptoms for COVID. So I do think they got about a 60% chance of showing a difference at the 800 (patient) mark.
Should Bucillamine show similar inclination to prevent hospitalization and death in patients with mild/moderate COVID, there’s presumably a good shot that Revive Therapeutics can obtain similar expedited trial success as Merck.
Bucillamine is an antirheumatic thiol-based agent used primarily in the therapy of inflammatory arthritis. Thiol-based drugs have been shown to decrease binding of SARS-CoV-2 spike protein to its receptor and inhibit SARS-CoV-2 cell entry. Bucillamine has also been proven to replenish glutathione in human cells, giving it power free radical scavenging capabilities.
Click on the embedded link for more of our informative and fascinating interview with Biomedical_trader, in his own words.