Pfizer, Merck launch large new trials of oral COVID-19 drugs

 

• Pfizer and Merck & Co. each launched pivotal clinical studies of new experimental oral COVID-19 drugs, building on previous work to provide outpatient alternatives for patients.
• Merck is studying whether its medicine, molnupiravir, can prevent COVID-19 in adults who live with a symptomatic patient with a confirmed coronavirus infection. The trial will include about 1,300 patients who will take molnupiravir or a placebo every 12 hours for five days.
• Pfizer said the first of about 1,140 patients has received a dose of its therapy in a trial to treat symptomatic patients who have not been hospitalized and aren’t at high risk of severe illness. The dosing of the Pfizer treatment – a combination of an older medicine and an experimental drug called PF-07321332 – is also every 12 hours for five days and measured against a placebo.

With the battle against COVID-19 far from over, the two giant drugmakers are betting on continued demand for medications that can treat and prevent infections. And easy, oral treatments would provide an attractive alternative to existing monoclonal antibody therapies that require infusions in health-care settings.

Pfizer executives told investors in July that they see a sustained market for COVID-19 therapies as virus mutations and vaccine hesitancy leave the world exposed. The company estimated that hundreds of millions of patients may be candidates for its new COVID-19 therapy.

Pfizer’s treatment is a combination of protease inhibitors, a type of medicine long used to battle HIV. The idea is to block an enzyme that the coronavirus needs to replicate, helping the body combat the intruder. The combination includes ritonavir, a 25-year-old drug sold under the brand name Norvir by AbbVie.

The company in July also began studying the combination in non-hospitalized COVID-19 patients who are at increased risk of severe disease. Pfizer told investors it’s hoping to seek emergency approval of the therapy in the fourth quarter.

Merck is working with Ridgeback Biotherapeutics on its option, which is also being studied as a treatment for patients with mild to moderate COVID-19 and at least one risk factor for a poor outcome. Data from that trial is due before the end of the year.

The new study, dubbed MOVe-AHEAD, is taking place in more than a dozen countries, including the U.S., Brazil and South Africa. Researchers will look at how many patients develop symptomatic COVID-19, how many experience an adverse event and how many drop out because of an adverse event after 14 days.

https://www.biopharmadive.com/news/pfizer-merck-launch-large-new-trials-of-oral-covid-19-drugs/605939/