RSV Antibody Passes Final Trials in Win for Merck

Merck & Co. hope to become the latest company to gain approval for a drug to avert the onset of respiratory syncytial virus (RSV) in healthy infants. Data shows that the monoclonal antibody reduced the occurrence of infections related to RSV in infants.

The therapy, named MK-1654 or Clesrovimab, according to the company’s press release from July 23rd, hit the primary endpoint of limiting the occurrence of infections related to RSV over a timeframe of 150 days when compared with a placebo. The drug, developed as a prophylactic for administration in infants, also met several important safety thresholds, including the number of trial participants who experienced any adverse events related to injections, adverse events of special interest, and serious adverse events.

However, to gauge the extent of these successes, there needs to be available data regarding the trial that was conducted. Merck has not yet provided it to the public, claiming it will release the data at a medical conference later and plans to share it with health authorities globally.

While developing Clesrovimab, since giving Moderna the RSV drug that was being created for adults, Merck has released several other drugs. One of these medicines is Winrevair, designed for pulmonary arterial hypertension. It has entered markets and is forecasted to have great sales potential worth billions of dollars. According to Merck, Clesrovimab is likely to show similar results.

To achieve the sorts of results that Merck expects, it has to meet a number of expectations set by its competitors, particularly Sanofi’s Beyfortus, according to analyst Peter Welford. Beyfortus’ use decreased the risk of lower respiratory disease by about 75 percent in one trial. In a follow-up trial, larger than the previous one, it reduced hospitalization by 83% for RSV-related illnesses. Additionally, a real-world experiment showed a similar figure of 82%, published in the journal Lancet.

Rising demand for these products has also been noted since last year and has been met with newer entrants to the market. Since 2023, three new vaccines have been released. Beyfortus, which prevents RSV-related illnesses in infants, is the most direct competitor to Merck’s Clesrovimab that has been released.

Owing to the spike in demand last fall, there have been significant sales reported for 2023 by companies such as GSK, which made $1.5 billion last year with its vaccine Arexvy. AstraZeneca and Sanofi failed to match supply with demand for Beyfortus as they generated $594 million in 2023.

These numbers make executives at Merck optimistic as they work to roll out their new therapy. “We are encouraged by these findings and look forward to working with regulators to provide a new option to help address the impact of RSV on infants and their families,” said Paula Annunziato, senior vice president of Merck Research Laboratories, in a press release about Clesrovimab’s trial results. Merck executives also contend that Clesrovimab’s single-dose usage, as opposed to Beyfortus’ two injections, is an advantage, as well as the low likelihood of the virus developing any resistance to it.

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