Merck KGaA's Evobrutinib Falls Short in Multiple Sclerosis Trials

Merck KGaA, a leading pharmaceutical company based in Germany, announced that its experimental multiple sclerosis (MS) drug, evobrutinib, did not meet the primary goal in highly anticipated late-stage trials. The failure dealt a significant blow to the company's growth ambitions.

Trial Results and Comparison with Aubagio

Reuters reported that in the Phase III trials, evobrutinib failed to reduce the annualized relapse rate compared to Sanofi's Aubagio, a well-established drug for patients with relapsing MS. Merck, in a statement released on Tuesday, acknowledged this setback, as per Bloomberg.

Merck was seen as a frontrunner in a competitive race alongside Sanofi, Novartis, and Roche to develop more targeted MS drugs known as Bruton's tyrosine kinase (BTK) inhibitors. However, the result of this latest trial has cast a shadow over Merck's position in this space.

The MS drug category, including BTK inhibitors like evobrutinib, has raised concerns about a possible link to liver damage. While these drugs are designed to selectively block cells that drive the harmful autoimmune reaction behind MS, safety and efficacy remain crucial factors affecting revenue prospects for pharmaceutical companies.

Importance of Evobrutinib's Success for Merck

Merck's specialty materials businesses recently faced challenges due to weak demand. Analysts believed that the successful launch of evobrutinib could help the diversified group achieve its goal of generating 25 billion euros ($27 billion) in sales by 2025—an increase from 22.2 billion euros in 2022.

Merck's CEO, Belen Garijo, expressed confidence in evobrutinib, stating that the MS drug had the potential to achieve "blockbuster" status, referring to annual sales exceeding $1 billion. However, concerns about potential liver damage emerged, potentially impacting the drug's success.

In April, Merck faced a setback when U.S. regulators paused enrolling new patients into a trial testing evobrutinib, citing lab results suggesting drug-induced liver injury. Sanofi encountered similar challenges with its BTK drug candidate, tolebrutinib.

In trials, Novartis reported no signs of liver damage testing its anti-inflammatory drug candidate, remibrutinib. In a midstage trial, Roche revealed that fenebrutinib, their BTK inhibitor against MS, reduced harmful brain lesions without any new safety concerns.

The failed trials of evobrutinib mark another significant setback for Merck's medium-sized pharma unit. This follows the disappointing results of bintrafusp alfa, a cancer drug that failed in a 2021 trial, leading to the end of an alliance with GSK.

Photo: Merck Newsroom