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The promising oral antiviral from Merck and Ridgeback Therapeutics Inc. could change the direction of the pandemic by making it easier for people with COVID-19 to take a pill at home that can keep them from getting seriously ill.
MRK from Merck,
The stock rose 9.1% in trading on Friday after announcing that the drug, molnupiravir, reduced the risk of hospitalization or death by 50% in a Phase 3 clinical trial. (Ridgeback is a private company. )
The drug, which inhibits virus replication, has been tested in 775 “at risk” adults with mild or moderate cases of COVID-19. No one taking the drug died during the trial; eight deaths were reported among those taking the placebo.
It also appeared to work against gamma, delta, and mu variants in about 40% of participants for whom sequencing was available.
“This is a very big deal,” said Dr Eric Topol, director of the Scripps Research Translational Institute, in an email. “If it’s safe and inexpensive (even available for free) in an easy-to-take pill form, it could have huge benefits in reducing serious illness, both for the unvaccinated and for those with a breakthrough vaccine. “
Topol on Twitter previously referred to molnupiravir such as ‘M-pack’, a game about commonly prescribed Z-Pack antibiotics.
The United States has already ordered 1.7 million courses of molnupiravir at a price of about $ 705 for each five-day course.
That said, there are still a few caveats. So far, the companies have only shared clinical data in a press release and not in a pre-print or medical study. It is also not known if any of the trial participants were vaccinated and if so, how much. (Topol noted that knowing that this wouldn’t detract from its potential importance.)
The case of new COVID-19 treatments
COVID-19 vaccines are by far the best therapeutic tool in our pandemic arsenal. Not only are they very effective in preventing people from ending up in hospital or dying, but they mostly prevent people from contracting even mild cases of COVID-19, although these breakthrough infections are on the increase.
There are a handful of therapies that can help COVID-19 patients who are at high risk of developing severe cases or who are already hospitalized, but they are all given as an infusion at a healthcare facility.
These include the monoclonal antibodies developed by Eli Lilly & Co. LLY,
Regeneron Pharmaceuticals Inc. REGN,
and Vir Biotechnology Inc. FOR,
and GlaxoSmithKline GSK,
Other therapies, such as Gilead Sciences Inc.’s GILD,
Veklury and the steroid dexamethasone, which has been reused as a COVID-19 drug, are reserved for critically ill hospital patients
When it comes to treatments for mild to moderate cases of COVID-19 among the general public, we have been unlucky. There are no Tamiflu-type pills that patients can take at home.
“The availability of an effective oral drug that can be administered on an outpatient basis can mitigate the risks associated with breakthrough infections and reduce mortality among the unvaccinated, which can begin to pull the country out of the pandemic and speed up reopening,” RBC Capital Markets analyst Brian Abrahams told investors Friday.
If and when the authorization or approval of molnupiravir and other investigational antivirals takes place, it will likely change the course of the pandemic and bring us closer to making the virus something we can live with and less to fear.
“The fact that this is going from a probably pandemic to more endemic, there is a real need for an antiviral,” Merck CEO Robert Davis said Sept. 13 at the Morgan Stanley Global Healthcare Conference, according to a FactSet transcript of the presentation.
Other COVID-19 antivirals in development
A half-dozen oral antiviral drugs are currently in development, spurred by a $ 3 billion investment from the National Institutes of Health in the development of COVID-19 antivirals in June.
Pfizer Inc. PFE,
already a pandemic favorite for its role in the development of Comirnaty, the first COVID-19 vaccine authorized and approved in the United States, is expected to have advanced clinical data for its experimental antiviral pill before the end of the year.
“We believe an oral hearing is an essential part of the solution to the pandemic,” Pfizer CFO Frank D’Amelio said Sept. 14 at a conference at Morgan Stanley. “It could be prescribed for 5 days of treatment at the first sign of infection before patients are hospitalized for intensive care.”
Pfizer and Merck are also testing their antivirals for COVID-19 post-exposure prophylaxis. In these cases, if a person is exposed to another person who has tested positive for the virus, they may take preventative medication to avoid infection with COVID-19.
Several other small drug and biotech manufacturers are also testing antivirals as COVID-19 treatments, including Adamis Pharmaceuticals Corp. ADMP,
Atea Pharmaceuticals Inc. AVIR,
and RedHill Biopharma Ltd. RDHL,
Gilead has also studied Veklury as a treatment for high-risk COVID-19 patients who have not been hospitalized.
Merck said on Friday that it plans to submit the data for emergency clearance soon.
Merck’s stock is down 3.7% for the year, while the larger S&P 500 SPX,
is up 14.7%.
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