Morphic’s Ulcerative Colitis Pill Misses Expectations in Mid-Stage Study, Stock Falls

IBS_iStock, Doucefleur

Pictured: Woman grasping her stomach in pain/iStock, Doucefleur

New data from the Phase IIa EMERALD-1 study showed that Morphic Therapeutic’s investigational ulcerative colitis pill MORF-057 induced endoscopic improvement, the company announced Friday.

However, investors were underwhelmed with the candidate’s new efficacy findings and Morphic’s stock price dropped around 25% after the data was released.

The new data, presented in a moderated poster session at the United European Gastroenterology Week (UEGW) 2023, showed that at 12 weeks, 25.7% of treated patients demonstrated endoscopic improvement.

Clinical response, measured using the modified Mayo Clinic Score (mMCS), was documented in 45.7% of participants at 12 weeks.

The UEGW data follow a prior readout from EMERALD-1, posted in April 2023, which showed that patients treated with MORF-057 saw a significant 6.4-point improvement in the Robarts Histopathology Index, a validated tool that measures histological disease activity in ulcerative colitis. This was accompanied by a 2.3-point reduction in the mMCS score.

Moreover, 25.7% of treated patients achieved clinical remission, as defined by the mMCS.

In both data drops, MORF-057 was generally well tolerated. EMERALD-1 found two cases of grade three treatment-emergent adverse events, both of which were an exacerbation of ulcerative colitis and were deemed unrelated to the oral candidate.

MORF-057 is an investigational and selective small molecule inhibitor of the α4β7 integrin, a clinically validated target for inflammatory bowel diseases such as ulcerative colitis. By blocking the interaction of α4β7 with its corresponding ligand, MORF-057 lessens the movement of lymphocytes from the bloodstream into intestinal mucosal tissue, thereby dampening inflammation.

MORF-057 shares this mechanism of action with Takeda’s Entyvio (vedolizumab), which was approved for this indication in May 2014. According to Morphic’s Friday announcement, Takeda Entyvio was able to elicit endoscopic improvement in nearly 40% of treated patients. However, this improvement was documented over 52 weeks of observation and in patients with less severe and less refractory disease.

“Comparing the results from different trials may be unreliable due to different protocol designs, trial designs, patient selection and populations, number of patients, trial endpoints, trial objectives and other parameters that may not be the same between trials,” according to Morphic’s announcement.

Unlike the therapeutic antibody, which is administered intravenously at regular intervals at 300-mg doses, MORF-057 is designed to be orally available and taken twice daily. Takeda’s VARSITY trial is also a much larger and later-stage study that used different tools to assess efficacy.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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