Morphic Therapeutic has encountered a setback, as more comprehensive data from its much-anticipated EMERALD-1 trial unveiled uncertainties, causing its stock to relinquish previous gains. Only months prior, the biotech company had successfully raised $240 million, propelled by promising initial results, fueling optimism about its oral ulcerative colitis candidate, MORF-057, as a potential rival to Takeda’s Entyvio.
The EMERALD-1 trial, an open-label, single-arm phase 2a study, administered MORF-057, an oral inhibitor of α4β7, to 35 adults suffering from moderate to severe ulcerative colitis. Early glimpses in April portrayed a promising picture, with 25.7% of participants achieving clinical remission after 12 weeks of bi-daily dosing. This sparked speculation about MORF-057’s comparative efficacy to Takeda’s injectable anti-α4β7 monoclonal antibody, Entyvio.
However, the unveiling of additional results during the United European Gastroenterology Week in Copenhagen has instigated fresh skepticism around MORF-057’s standing against Entyvio and other contenders in the ulcerative colitis treatment sphere. A key focal point of the discussion was the rate of endoscopic improvement.
By Week 12, the rate of endoscopic improvement aligned with the clinical remission rate at 25.7%, falling short of expectations set by other ulcerative colitis trials, where endoscopic improvement typically outpaces clinical remission. For context, Takeda’s phase 3 trial showcased rates of 31.3% and 39.7% for clinical remission and endoscopic improvement respectively at Week 52.
Drawing parallels between different clinical trials may potentially distort perceptions of efficacy, especially considering the contrast between Morphic’s smaller, single-arm study and Takeda’s extensive, controlled trial. Nonetheless, the precedent set by earlier studies had fostered expectations of a higher endoscopic improvement rate for Morphic.
The unfolding of this nuanced data precipitated a sharp decline in Morphic’s stock value, plummeting 29% to $36.68, effectively negating the uplift experienced following the initial data release in April. The stock, which had oscillated between $34 and $38 before the release, had ascended past $60 in the post-April announcement phase.
Despite the current turbulence, a randomised, double-blind, placebo-controlled phase 2b trial for MORF-057 is in progress. Scheduled for primary endpoint analysis in the first half of 2025, this trial holds the potential to clarify MORF-057’s legitimacy as a formidable contender in the ulcerative colitis treatment market.