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Our Take: Merck, Ridgeback could be first to receive EUA for COVID-19 pill

Oct 04, 2021

On Friday, Merck and Ridgeback Biotherapeutics said they were stopping a Phase III trial of molnupiravir based on interim results showing the oral antiviral drug reduced the risk of hospitalization or death in at-risk, nonhospitalized adults with mild to moderate COVID-19 by approximately 50%.

The companies said in a news release that they were stopping recruitment into the global study, called MOVe-OUT, based on the recommendation of an independent data monitoring committee and in consultation with the FDA.

The interim analysis included data from 775 trial participants who had been enrolled by or on Aug. 5. By the time the decision was made to stop recruitment, the companies said, more than 90% of the planned sample of 1,550 participants had been enrolled. None of the participants had been vaccinated.

To be eligible for the trial, the participants had to have at least one risk factor associated with poor outcomes (e.g., obesity, age 60 or older, diabetes, or heart disease), have laboratory-confirmed mild to moderate COVID-19, and have onset of symptoms within 5 days of being randomized into the study.

The results of the planned analysis showed that 14.1% of those who received placebo were hospitalized or died through day 29 following randomization into the trial (the primary efficacy objective), compared with 7.3% of those who received the study drug. There were no deaths in the group treated with molnupiravir and eight deaths in the placebo group.

Of note, the companies said the study drug showed consistent efficacy across the gamma, delta, and mu variants among the roughly 40% of participants with available viral sequencing data.

Similar proportions of the molnupiravir group and the control arm experienced any adverse event (35% and 40%, respectively) or a drug-related adverse event (12% and 11%, respectively). Fewer people discontinued treatment because of an adverse event in the molnupiravir group than in the placebo group (1.3% vs. 3.4%). The companies did not specify what the adverse events were.

“[A]ntiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” said Wendy Holman, CEO of Ridgeback Biotherapeutics. “We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic.”

Merck said it intends to submit an application to the FDA for emergency use authorization (EUA) as soon as possible and expects to produce 10 million courses of treatment by the end of this year.

In separate news, Regeneron Pharmaceuticals announced Wednesday that The New England Journal of Medicine published results from a Phase III trial showing that REGEN-COV, a combination of casirivimab and imdevimab, reduced the risk of hospitalization and death by 70% compared with placebo in high-risk, nonhospitalized people infected with COVID-19. The combination therapy also resolved symptoms an average of four days earlier than placebo (10 days vs. 14 days).

REGEN-COV is authorized for emergency use as a treatment for mild to moderate COVID-19 in nonhospitalized individuals age 12 or older who are at high risk of progressing to severe COVID-19, and for post-exposure prophylaxis of COVID-19 in certain settings.

Our Take: We’re curious as to whether the FDA will require clinical data on the use of molnupiravir in vaccinated individuals before including them in a potential EUA. Although most so-called breakthrough cases are not severe, some vaccinated people who become infected do end up being hospitalized.

We also wonder whether the drug might eventually be authorized or approved for people who don’t have a medical condition that places them at risk for developing a serious case of COVID-19.

Numerous news stories over the past year and a half have compared molnupiravir to Tamiflu (oseltamivir), which is used to minimize the severity of influenza. It would be truly excellent, of course, if molnupiravir or some other drug could eventually be used like Tamiflu, but we’re likely still a long way away from that day.

Regardless, Merck and Ridgeback’s news is good for those who can’t or don’t want to be vaccinated. Unlike the vaccines, molnupiravir won’t have any impact on transmission of the coronavirus, but it appears as though it can help reduce COVID-related hospitalizations and deaths. Any addition to the arsenal against the disease is helpful.

The news bodes well for Ridgeback Biotherapeutics, too. Ridgeback licensed the investigational compound from Emory University in March 2020 and then sold the license to Merck a couple of months later. The two companies entered into a collaboration agreement in May 2020 to develop the drug, and as part of that agreement Ridgeback will receive milestone payments and a share of the net proceeds if the drug is approved.

Molnupiravir will have competition. Pfizer just started a Phase II/III trial last week to evaluate a novel protease inhibitor, PF-07321332, in preventing illness in adults living with someone who’s infected with COVID-19 and is symptomatic. The investigational compound is being co-administered with a low dose of ritonavir. Unlike molnapiravir, which initially was being developed as a treatment for flu and other viruses, Pfizer’s drug was developed specifically for SARS-CoV-2.

Roche and Atea Pharmaceuticals also have an oral antiviral drug, RG6422/AT-527, in late-stage clinical development for COVID-19. Atea was evaluating the compound as a treatment for hepatitis C before entering into the collaboration with Roche a year ago.

What else you need to know
Merck will pay approximately $11.5 billion to acquire Acceleron Pharma, a biopharmaceutical firm based in Cambridge, Massachusetts, that focuses on the transforming growth factor-beta superfamily of proteins to develop therapeutics for pulmonary and hematologic diseases. Acceleron’s portfolio includes Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation recombinant fusion protein approved in 2019 for treating anemia in patients with certain rare blood disorders, and sotatercept, a potential first-in-class compound in Phase III development as a treatment for pulmonary arterial hypertension. If the necessary regulatory approvals are obtained and other closing conditions are met, the transaction is expected to close in the fourth quarter, the firms said in a news release.

Pfizer and BioNTech submitted initial data from a pivotal Phase II/III trial of their COVID-19 vaccine in children ages 5 through 11 to the FDA last week. The companies said in a press release that the results from this trial were comparable to those from an earlier study in teens and young adults ages 16 to 25. The vaccine “demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10-microgram doses,” they noted. That’s one-third of the dosage used in adults. The firms plan to request emergency use authorization of the vaccine in children ages 5 through 11 “in the coming weeks.” Two younger cohorts are also participating in the trial, including children as young as 6 months. Top-line data for those cohorts could be available later this year, the companies said.

A new coalition has been launched to reform pharmacy benefit manager (PBM) practices. Six national organizations that represent pharmacies, small business employers, patient advocates, and medical groups established the Coalition for BPM Reform. In a news release, the National Community Pharmacists Association said, “The three largest PBMs are all Fortune 15 companies. They control nearly 80% of all prescriptions filled in the U.S. … Transparency and information are the keys to any healthy market. They form the basis on which consumers can make decisions. Those elements are largely absent from the prescription drug market, and this coalition aims to change that.”

The National Association of ACOs published a white paper outlining policy recommendations to better position ACOs to address health inequities and social determinants of health. The recommendations include providing financial support in the form of grant money to expand social services, as well as offering higher benchmarks to help ACOs that treat vulnerable populations and adopting the Center for Medicare and Medicaid Innovation’s CHART model, which would provide upfront money to support the formation of ACOs in rural areas. In a press release, Clif Gaus, the organization’s CEO, said, “CMS and Congress should work through ACOs to improve inequities and address social determinants. The implementation of these recommendations will ensure that all ACOs are equipped to advance health equity in their work while improving quality of care and controlling costs.”

Intermountain Healthcare launched a new company called Tellica Imaging that will provide “high-quality, convenient, low-cost MRI and CT scan services.” Later this year, the new subsidiary will begin opening stand-alone outpatient imaging centers in Utah, with the first three planned for Ogden, West Valley City, and Orem. As many as five more are in the works for 2022, the health system said in the announcement, noting that “[a]ll Tellica locations will offer … flat-rate prices that fall below the costs in typical hospital-based imaging settings.”

Walmart will use Epic’s electronic medical record platform to support all of its health and wellness lines of business, including virtual care, the retailer said in a news release. The platform will be implemented initially in four new Walmart Health Centers slated to open in Florida early next year and gradually rolled out to other locations throughout the country.

The merger between Spectrum Health and Beaumont Health will take longer than anticipated because of a surge in filings at the Federal Trade Commission, the two Michigan-based health systems said in a statement released Sept. 24. They noted that they are responding to a request from the FTC for additional information and proceeding with “pre-integration planning.” When the health systems announced the signing of a formal integration agreement in early September, they said they hoped to launch the combined health system this fall. No new estimate was provided for the launch.

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