It’s already had to give up on any hopes of creating a vaccine against COVID-19, and now Merck is being told that its pandemic drug hopeful will need another trial before it can be issued a green light.
We found out last week that Merck will no longer be able to supply the experimental COVID-19 drug from its $425 million buyout of OncoImmune to the U.S. government, from which it was granted a $356 million contract, as the FDA demanded more data.
Now, Merck has told Bloomberg that it “is preparing to launch a fresh clinical trial” to address the FDA’s concerns, although it did not specify what they were.
“It’s not that the agency wasn’t impressed by the data, because they were,” said Nick Kartsonis, M.D., senior vice president of clinical research for infectious diseases and vaccines at Merck, in an interview with Bloomberg. “They just want more of it, and more comfort that if we’re indeed going to bring this forward, that the data gets replicated.”
This med, now known as MK-7110 (formerly CD24Fc) was initially used in allogeneic hematopoietic stem-cell transplant patients. But the biotech believed it could be used to help certain COVID-19 patients.
Janet Woodcock, M.D., the FDA’s current director (and in the running for the full-time job), asked Moncef Slaoui, then chief scientific adviser to the Operation Warp Speed program, to get this drug into the hands of a bigger pharma after seeing the initial results, which appeared positive.
According to Bloomberg, Slaoui arranged a marriage between the two to add firepower to the med, and, a month after the deal, Merck nabbed a $356 million contract to deliver 100,000 doses of the med by the summer. It will now miss that deadline, as a new late-stage trial will only add many more months to its development.
OncoImmune began a clinical trial in April to test the theory that CD24Fc fortifies an innate immune checkpoint against excessive inflammation.
This was enough to grab the attention of Merck, which spent $425 million to buy the company and the drug late last year, with OncoImmune later reporting top-line findings from an interim efficacy analysis of a phase 3 study of 203 participants (75% of the planned enrollment) showing that selected hospitalized patients with COVID-19 treated with a single dose of MK-7110 showed a 60% higher probability of improvement in clinical status compared with placebo, as defined by the protocol.
The risk of death or respiratory failure was reduced by more than 50%. Merck says full results from this phase 3 study, “which were consistent with the topline results,” were seen by the company last month. Something, however, is clearly amiss, given the FDA’s demands.