Friday, October 18, 2024

Rahway Poised To Compete With AZ/Sanofi's Monoclonal Antibody Therapy For RSV Virus, By Year End -- With MK-1654 | Clesrovimab


At the moment, the AZ/Sanofi monoclonal antibody therapy sold under the Beyfortus trademark is far and away the market leader. Many may recall that Merck returned a different RSV therapeutic candidate to Moderna, which subsequently brought it to market -- with mixed results. Merck chose wisely to focus on MK-1654, and now a Phase 2b/3 trial has validated that bet.

Rahway said this week it hopes to have fully-scaled stock available for the Spring 2025 RSV infections "season". And we should note that both GSK and Pfizer now offer approved vaccines for RSV -- so the uptake on the therapy may "only" reach around $700 million a year, at peak sales -- in a few years' time, for Merck. Still, it is very good news -- per Fierce Biotech's reporting:

. . .Three months after revealing that its respiratory syncytial virus (RSV) preventive antibody clesrovimab had passed muster in a phase 2b/3 trial, Merck is putting numbers to the claim.

Clesrovimab, also known as MK-1654, scored on multiple trial endpoints, demonstrating its ability to protect infants against the virus in their first RSV season.

With the results, which were presented Thursday in Los Angeles during IDWeek 2024, Merck said it hopes to bring clesrovimab to the market for the 2025-26 RSV season. . . .

Clesrovimab achieved its primary objective by reducing the incidence of RSV-associated medically attended lower respiratory infections requiring at least one indicator of lower respiratory infection by 60% versus placebo through the first five months after dosing, the company said.

The drug also reduced RSV-related hospitalizations (secondary endpoint) and RSV-related lower respiratory infection hospitalizations (tertiary endpoint) by 84% and 91%, respectively, versus placebo through five months. . . .


Now you know -- and onward, to a Buff win tomorrow afternoon, in the Arizona desert heat. Grin. . . .

नमस्ते

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