Merck Germany's Two Pivotal Trials Flunk In Multiple Sclerosis

Merck KGaA MKGAF MKKGY says its two Phase 3 EVOLUTION trials (evolutionRMS 1 and evolutionRMS 2) of evobrutinib did not meet their primary endpoints of reducing annualized relapse rates (ARR) in people with relapsing multiple sclerosis (RMS) compared to Sanofi SA's SNY Aubagio (teriflunomide).

The data showed the rates of 0.11 vs. 0.11 in evolutionRMS 1 and 0.15 for evobrutinib vs. 0.14 for teriflunomide in evolutionRMS 2, p=NS in both trials. 

Teriflunomide ARR values were lower than reported in other recent Phase 3 studies. 

The overall safety and tolerability profile was consistent with the previously reported Phase 2 trial results. 

Investors have been unsettled regarding revenue projections due to potential liver damage associated with a specific drug category aimed at selectively targeting cells driving the adverse autoimmune response in multiple sclerosis (MS).

Despite this concern, citing some analysts, Reuters notes that Merck's drug can achieve annual peak sales well surpassing $2 billion on average.

JP Morgan analysts expressed surprise, citing the unexpected disappointment stemming from concerns about side effects rather than the drug's effectiveness.

In a note, the analysts mentioned, "We had anticipated successful trials and the product's market launch outside of the United States."