Merck Merck received full results from OncoImmune’s late-stage study that were c
2 min read . Updated: 02 Mar 2021, 09:51 PM IST- Merck received full results from OncoImmune’s late-stage study that were consistent with the earlier, positive results
Merck & Co. is preparing to launch a fresh clinical trial of an experimental Covid-19 treatment gained in a November deal after U.S. regulators said results from a small study weren’t sufficient to seek clearance.
The drugmaker will start a late-stage trial of MK-7110, a therapy for severely ill Covid patients, to address the concerns brought forth by the Food and Drug Administration, said Nick Kartsonis, senior vice president of clinical research for infectious diseases and vaccines at Merck Research Laboratories.
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The additional work will put Merck months away from potentially filing for emergency clearance and bringing the therapy to patients. The company hopes to generate the needed data before the end of the year.
Merck announced earlier this year that it had discontinued its Covid-19 vaccine program in the wake of lackluster data out of early trials. Several of its vaccine manufacturing facilities dedicated to the pandemic response have already been re-tooled to produce MK-7110, and the production scale-up continues as planned, Kartsonis said.
Merck will also use its facilities to help make Johnson & Johnson’s single-shot Covid-19 vaccine, a Biden administration spokesman said on Twitter. President Joe Biden will announce the partnership between J&J and Merck later Tuesday, White House Chief of Staff Ron Klain said in separately in a tweet. The FDA cleared the shot for emergency use late Saturday.
Kenilworth, New Jersey-based Merck rose as much as 1.5% as of 9:45 a.m. in New York.
The drugmaker gained the potential Covid therapy MK-7110 in its $425 million acquisition of OncoImmune Inc., then a 10-person biotechnology company based in Rockville, Maryland that had spent decades developing drugs to target inflammation. An interim analysis of trial data indicated the drug significantly improved the chances and speed of recovery for severe and critical Covid patients needing oxygen, reducing the risk of respiratory failure and death by 50%.
Janet Woodcock, FDA’s current director who last year led the search for therapeutic candidates in the Trump administration, reviewed the interim results from little-known OncoImmune last fall. She immediately informed Moncef Slaoui, then chief scientific adviser to the Operation Warp Speed program to accelerate Covid drugs and vaccines.
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Within weeks, Slaoui facilitated a marriage between the tiny biotech and Merck in hopes that the drug giant would bring manufacturing firepower to produce the complex intravenous drug. By late December, Merck had clinched a $356 million deal to deliver as many as 100,000 doses of MK-7110 to the U.S. by the end of June.
Merck received full results from OncoImmune’s late-stage study that were consistent with the earlier, positive results. Still, the data from just a few hundred patients wasn’t enough get it across the finish line in the eyes of regulators.
“It’s not that the agency wasn’t impressed by the data, because they were," Kartsonis said in an interview. “They just want more of it, and more comfort that if we’re indeed going to bring this forward, that the data gets replicated."
FDA officials declined to comment.
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