A news release from pharmaceutical company Merck last October 1 details positive findings after completion of Phase 3 human trials for their novel COVID-19 oral medicine, called molnupiravir. Developed in collaboration with Ridgeback Biotherapeutics, the novel medicine to address the current coronavirus pandemic resulted in about 50% less risk of hospitalization and death. These results were obtained from participants taking the medicine five (5) days after COVID-19 symptoms first appeared, in a span of five (5) days of daily treatment.
The pharmaceutical company was originally devising molnupiravir as an antiviral agent targeting RNA viruses back in late 2019, and was planned to take on influenza; plans were shifted around, however, at the onset of the COVID-19 pandemic by 2020.
Merck was already through 90% of its intended 1,550-individual phase 3 trial when an independent data monitoring board halted the test based on its positive interim results. The October 1 press release from Merck highlights data gathered from the first 775 patients.
Divided into a placebo group and a test group who took molnupiravir, the trial proceeded. In it, 28 of the 385 patients in the test group needed hispitalization from COVID-19 symptoms, compared to 53 out of 377 patients in the placebo group. Of the 385-strong test group, none died; eight (8) deaths, however, were recorded from the placebo group. This difference in results led to about a 50% decrease in the rate of hospitalization that Merck and Ridgeback reports.
Merck CEO and president Robert Davis looks ahead to further reassessment and eventual government certification of the drug, as “[more] tools and treatments are urgently needed to fight the COVID-19 pandemic.” Ridgeback Biotherapeutics CEO Wendy Holman, on the other hand, believes that “antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed.”
Holman continued: “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. Our partnership with Merck is critical to ensuring rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development.”
Simon Clarke, cellular microbiologist from the University of Reading in the United Kingdom, details that “[this] drug works by causing the machinery that reproduces Covid-19’s genetic material to make mistakes, thereby stopping effective replication,” yet also expresses inhibitions about what possible side-effects it may impart to the body. “That mode of action could cause problems with our own cells, and while reports are that the drug is well tolerated, we still don’t have full details of any side effects.”
Merck estimates that the five-day daily treatment with molnupiravir will cost about US$700; they also mentioned implementing a “tiered” system to ensure that accessibility to the drug based on financial capacity will be maximized.
Despite this, Peter English, a former chairperson of the Public Health Medicine Committee of the British Medical Association, expressed concerns regarding the pricing of the drug. “In my opinion, these drugs might have a role IF you can first identify people at risk of more serious disease. […] Unless an antiviral medication could be made so cheap and so safe that it can be used ‘on spec’ by people who might have COVID-19, they are unlikely to be widely useful.”
Davis, however, remains optimistic about the future of their potential new COVID-19 pill. “With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most.” He continued: “Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”
In the future, Merck is looking to secure emergency use authorization from the United States (US) Food and Drug Administration. The US government is set to receive 1.7 million courses of molnupiravir as part of its preorder.
(For more on Modern Sciences’ coverage of the COVID-19 pandemic, check out our piece on how the SARS-CoV-2 virus invades human cells for infection. SImilarly, check out our piece on a study of how the virus’ infamous Delta variant swept over the world.)
References
- Haridy, R. (2021, October 3). First COVID-19 pill passes human trials, looks to FDA approval. New Atlas. https://newatlas.com/health-wellbeing/merck-covid19-molnupiravir-human-trial-eua-approval/
- Merck and ridgeback biotherapeutics provide update on progress of clinical development program for molnupiravir, an investigational oral therapeutic for the treatment of mild-to-moderate covid-19. (2021, April 15). Merck. https://www.merck.com/news/merck-and-ridgeback-biotherapeutics-provide-update-on-progress-of-clinical-development-program-for-molnupiravir-an-investigational-oral-therapeutic-for-the-treatment-of-mild-to-moderate-covid-19/
- Merck and ridgeback’s investigational oral antiviral molnupiravir reduced the risk of hospitalization or death by approximately 50 percent compared to placebo for patients with mild or moderate covid-19 in positive interim analysis of phase 3 study. (2021, October 1). Merck. https://www.merck.com/news/merck-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderat/
