April 11, 2021

Merck aims to start ‘large pivotal’ studies on coronavirus treatment in September

A research lab at Merck

John Tlumacki | The Boston Globe | Getty Images

Merck has scheduled “very large pivotal studies” for its oral coronavirus treatment in collaboration with Ridgeback Biotherapeutics as early as September, a company executive said Friday. 

“We will be embarking, probably in September, on very large pivotal studies, and so those are going to be the important ones,” Dr. Roger Perlmutter, president of Merck Research Laboratories, said on the company’s second-quarter earnings call. 

The experimental oral therapeutic, known as MK-4482, that would fight against Covid-19 is currently in phase two trials. The drug, if approved, would join Gilead‘s remdesivir in helping critically ill coronavirus patients. The company doesn’t want to “dribble out data” on the drug’s performance in phase two trials yet, Perlmutter said. 

“The good news about MK-4482 is that because it’s an oral drug given in capsules, it can be easily administered from the time that people have symptoms,” Perlmutter said. 

He said the goal of future studies will be to prove the drug can reduce the duration of Covid-19 symptoms and, more importantly, keep people from developing serious illness that could send them to the hospital or intensive care unit. 

The company is also developing two separate potential coronavirus vaccines. Merck recently acquired Austrian vaccine maker Themis Bioscience, which is developing a Covid-19 vaccine with Institut Pasteur and the University of Pittsburgh. The company said Friday that clinical trials for the candidate are scheduled to begin in the third quarter. 

Clinical trials for the another vaccine, which Merck is developing with scientific research nonprofit IAVI, will begin later this year, according to the company’s earnings statement. Merck has yet to begin human trials for its vaccine candidates, well behind some competitors like Moderna and Pfizer, which began their late-stage human trials on Monday. 

The community at large should be very encouraged by the enormous numbers of vaccine doses that are being planned for manufacturing, particularly as we get into 2020 and beyond,” Perlmutter said during Friday’s call.

“If these vaccines are effective, I think the industry is going to people able to produce enough material ultimately to provide vaccination for a substantial fraction of the world’s population,” he said. 

Merck beat Wall Street expectations in the second quarter and raised its overall earnings guidance for the year when it reported its earnings Friday, saying the worst of the coronavirus pandemic is behind it. 

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