Merck to Launch New Late-Stage Trial of Experimental COVID-19 Treatment

Merck is planning to launch a new late-stage trial of an experimental COVID-19 treatment, MK-7110 (CD24Fc), because the previous phase 3 study enrolled too few participants to support regulatory clearance from the FDA.

Merck gained access to MK-7110, a recombinant fusion protein meant to alleviate inflammation, after purchasing therapeutics maker OncoImmune for $425 million toward the end of last year (DID, Nov. 24, 2020). Interim phase 3 results showed great promise, with the treatment providing a more than 50 percent reduction in risk of death or respiratory failure for patients hospitalized with moderate-to-severe COVID-19 infections (DID, Dec. 28, 2020).

The study, which enrolled 243 patients, ended in late January, according to ClinicalTrials.gov ― and Merck has yet to release the full findings, despite the final results reported to be in line with the earlier, positive interim data. A Merck spokesperson declined comment.

Merck has negotiated a $356 million supply agreement with the U.S. government for up to 100,000 MK-7110 doses to be delivered by the end of June, but the company is now delayed in receiving regulatory clearance. The New Jersey drugmaker is at best months away from having the efficacy data needed to support either an approval or Emergency Use Authorization.

The drugmaker does have another COVID-19 therapeutic candidate in the pipeline, MK-4482 (molnupiravir), developed in collaboration with Ridgeback Bio.

The drug, an antiviral first developed to treat influenza, is being evaluated as a COVID-19 treatment in multiple trials. An initial, small phase 2a study concluded late last month, another small phase 2a study is expected to finish in late May and two larger phase 2/3 trials are expected to have results by the end of June, according to ClinicalTrials.gov.

Earlier this week, Merck was in the news when the White House announced the company would help produce Johnson & Johnson’s just cleared single shot COVID vaccine, by manufacturing its drug substance and expanding fill-finish capacity (DID, March 3).

Despite its longstanding success in vaccine development, Merck announced earlier this year that it would drop its COVID-19 vaccine program following disappointing phase 1 study results on a promising candidate (DID, Jan. 26). ― Jason Scott