Merck aims to start ‘big pivot’ studies on coronavirus treatment in September

Merck & Company, Inc., dba Merck Sharp & Dohme outside the United States and Canada, is an American pharmaceutical company and one of the largest pharmaceutical companies in the world.

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

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

Experimental oral therapeutics, known as MK-4482, that would fight Covid-19 is currently in phase two trials. The drug, if approved, would be linked to Gilead’s remdesivir to help seriously ill coronavirus patients. The company does not yet want to “derive data” on the drug’s performance in the phase two trials, Perlmutter said.

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

He said the goal of future studies will be to show that the drug can reduce the duration of Covid-19 symptoms and, more importantly, prevent people from developing serious illnesses that can 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 the Pasteur Institute 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 other vaccine, which Merck is developing with IAVI nonprofit scientific research, will begin later this year, according to the company’s income statement. Merck has yet to begin human trials for its vaccine candidates, far behind some competitors such as Moderna and Pfizer, which began their late-stage human trials on Monday.

The broader community should be very encouraged by the huge amount of vaccine doses that are being planned for manufacturing, particularly as we move into 2020 and beyond, “Perlmutter said during the call on Friday.

“If these vaccines are effective, I think the industry will turn to people capable of ultimately producing enough material to provide vaccines to 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 earnings on Friday, saying the worst of the coronavirus pandemic is behind it.