- An experimental pill meant to combat the new coronavirus appears to be safe and at least somewhat effective at cutting down the time that patients test positive for SARS-CoV-2 infection, according to early data from its developers Merck & Co. and Ridgeback Biotherapeutics.
- The data come from a Phase 2 study that enrolled just over 200 people with confirmed, active SARS-CoV-2 infections who showed symptoms of coronavirus disease. Participants were given either a placebo or Merck and Ridgeback's pill, called molnupiravir, and then monitored. The companies reported Saturday that among 72 evaluable patients, none of the 47 who took molnupiravir tested positive for infectious virus five days after treatment. Meanwhile, six of the 25 patients in the placebo group had positive viral cultures.
- Merck and Ridgeback also said their drug was well-tolerated, with no safety signals identified so far. Though the companies found the early signs of safety and efficacy encouraging, they have yet to offer a look how molnupiravir fared on the study's main goal — which also evaluates the pill's impact on infection timelines, but by using a more common type of virus test.
Compared to the record-breaking speed at which multiple, effective vaccines for SARS-CoV-2 were developed, the hunt for drugs that can treat already infected patients has disappointed.
For those who are hospitalized, drug treatment is mostly limited to the steroid dexamethasone and Gilead's antiviral drug Veklury. While the Food and Drug Administration has also given emergency clearance to three antibody-based therapies for infected patients at high risk of developing severe disease or ending up in the hospital, they've been underutilized because of logistic challenges.
The need for more treatment options has pushed companies like Merck to test other approaches. Last May, the company made a flurry of deals related to the coronavirus pandemic, including an agreement with Miami-based Ridgeback that provided rights to molnupiravir, a drug originally developed at Emory University.
As an oral drug, molnupiravir could be a major help to patients and hospital systems still stretched thin, given that pills are much easier to administer than infused medicines like Veklury and antibody therapies.
The data presented Monday at the 2021 Conference on Retroviruses and Opportunistic Infections provide encouraging, but early, evidence that Merck and Ridgeback's drug can reduce the length of time infected people remain positive for the virus.
Merck also made note of the drug's safety, stating that none of the four serious adverse events seen in the trial were considered to be related to molnupiravir.
Aside from clinical studies, Merck said it conducted a "comprehensive" nonclinical program to better understand the drug's safety profile. The company claims the data from these studies indicates molnupiravir is not mutagenic or genotoxic when administered directly into mammals — a concern held by some for the drug.
Merck "went out of the way to call out the 'comprehensive' nonclinical program," wrote Umer Raffat, an analyst at EverCore ISI. The company is "a very conservative R&D organization — so for them to make this statement is a big deal," Raffat added.
Still, the data are very limited. They're from a secondary endpoint, and only encompass 72 of the 202 patients enrolled in the trial. More data are needed to evaluate molnupiravir's clinical merit, most importantly results from a closely watched Phase 3 trial that's excepted to produce data shortly.
Success with molnupiravir would be a reversal of fortune for Merck, which began coronavirus-related research later than some of its pharmaceutical peers and has yet to make much of a mark.
Alongside the Ridgeback deal, the company inked separate agreements last May to gain access to two experimental coronavirus vaccines. But both underperformed in early testing, leading Merck to stop development last month in a major setback for the company.
The FDA, meanwhile, has signaled it wants to see more data on another would-be COVID-19 drug Merck acquired, via a buyout of OncoImmune.