Jessica Allegretti, MD: Closing the Books on CP101

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Thus far, the phase 2 data on CP101 was generally positive for the treatment of recurrent C difficile infections.

The race for a next live microbiota treatment to gain US Food and Drug Administration (FDA) approval for the prevention of recurrent clostridiodes difficile infections (CDI) was abruptly ended last month after Finch Therapeutics announced they will not be moving forward with CP101.

CP101 is an investigational oral microbiome candidate that was being evaluated through the PRISM4 trial.

Despite positive data through phase 2 trials, the company said on Jan. 24 they are ending their C difficile clinical program.

In an interview with HCPLive®, Jessica R. Allegretti, MD, MPH, Medical Director, Crohn’s and Colitis Center, Brigham and Women’s Hospital, said it was disappointing that she will no longer be able to be a part of the clinical trial for the product.

“Overall, I was generally sad and disappointed,” she said. “I understand that things happen and there are financial constraints, but overall I’ve been intimated involved in this program since its inception and was a big part of the phase 2 trial. What I’m most disappointed about is that a product like CP101, which I know works, will never get to market and never get to patients.”

The decision comes after the company opted to focus on other intellectual property estates and other assets and specifically for CP101 because of slower than anticipated enrollment, the impact of unauthorized use of intellectual property, and broader sector trends. The company will also reduce its workforce by 95%.

However, there might still be options for patients with recurrent CDI as another live microbiota therapeutic, RBX2660, was approved in 2022 and the FDA is expected to make a call on SER-109 in April.