Merck to seek emergency clearance for oral treatment for Covid-19

Merck and Ridgeback Biotherapeutics plan to seek emergency clearance for their oral antiviral treatment for Covid-19, after the drug showed “convincing results” in clinical trials.

The drug, molnupiravir, has reduced the risk of hospitalization or death by about 50% for patients with mild or moderate cases of Covid-19, the companies said on Friday. Molnupiravir is taken by mouth and works by inhibiting the replication of Covid-19 inside the body.

An interim analysis of a phase 3 study found that 7.3% of patients treated with molnupiravir were hospitalized within 29 days. Of the patients who received placebo, 14.1% were hospitalized or died on day 29. No deaths were reported in patients who received molnupiravir during the 29-day period, while 8 deaths were reported. have been reported in patients treated with placebo.

All 775 participants in the trial had symptomatic laboratory-confirmed Covid-19 and were randomly given molnupiravir or placebo within five days of the onset of their symptoms.

Each participant was not vaccinated and had at least one underlying factor that made them more at risk of developing a more severe case of the virus. The most common risk factors were obesity, being over 60, diabetes and heart disease.

Phase 3 of the trial was conducted at more than 170 sites, in countries such as the United States, Brazil, Italy, Japan, South Africa, Taiwan and Guatemala.

The effectiveness of molnupiravir was not affected by the timing of symptom onset or the patients’ underlying risk factors, the study showed. It has also been shown to be consistently effective in treating all variants of Covid-19, including the widely dominant and highly transmissible Delta strain.

Adverse events were comparable in the molnupiravir and placebo groups, with approximately 10% of adverse events reported. Only 1.3% of the molnupiravir group stopped treatment because of an adverse event – less than the 3.4% of the placebo group who did.

Enrollment in the study was terminated prematurely due to the positive results, on the recommendation of an independent data oversight committee and in consultation with the United States Food and Drug Administration.

Merck is also currently testing molnupiravir in a separate global Phase 3 study to assess its effectiveness in preventing the spread of Covid-19 within households.

Robert M. Davis, CEO and chairman of Merck, said in a press release Friday that the company will do everything possible to get molnupiravir to patients as quickly as possible.

“With these compelling results, we are optimistic that molnupiravir may become an important drug in the global pandemic efforts,” he said.

Ridgeback Biotherapeutics CEO Wendy Holman added, “With the virus continuing to circulate widely, and because currently available treatment options are infused or require access to a health facility, antiviral treatments that can be taken. home to keep people with Covid-19 out of the hospital is absolutely necessary. “

“We are very encouraged by the results of the interim analysis and hope that molnupiravir, if allowed to be used, can have a profound impact on the control of the pandemic,” she said.

Merck said on Friday that it plans to seek emergency use authorization for the drug in the United States as soon as possible. The company also plans to submit marketing applications to other international drug regulatory bodies.

If cleared by regulatory agencies, molnupiravir could be the first oral antiviral drug against Covid-19. Antiviral treatments currently in use, such as remdesivir, are administered intravenously.

Merck has already started producing molnupiravir. The pharmaceutical giant plans to produce 10 million courses by the end of 2021, and more doses in 2022.

Earlier this year, Merck agreed to supply the United States with approximately 1.7 million cycles of molnupiravir. This agreement is dependent on obtaining emergency use authorization or FDA approval for molnupiravir.

Merck has also entered into supply and purchase agreements for the drug with other governments – pending regulatory approval – and is in discussions with other governments over the supply of molnupiravir.

The company said on Friday that it plans to implement a tiered pricing approach based on World Bank country income criteria to ensure access to molnupiravir globally. Merck previously announced that it has entered into voluntary non-exclusive licensing agreements for molnupiravir with generic manufacturers, an initiative to help low- and middle-income countries access treatment. These agreements are also pending emergency approvals or authorizations from local regulators.

Ridgeback has received an upfront payment from Merck as part of the collaborative company development of molnupiravir. The company is also eligible to receive conditional payments based on development and regulatory approval milestones.

Profits from the collaboration will be split equally between Merck and Ridgeback.