Finch Halts Phase 3 Trial for CP101 for Recurrent CDI

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The company announced they will no longer pursue approval for the treatment despite positive data from recent phase 2 trials.

Finch Therapeutics will not be continuing with a phase 3 trial testing CP101, a potential live microbiota therapeutic for the prevention of recurrent clostridiodes difficile infections (CDI).

CP101 is an investigational oral microbiome candidate that was being evaluated through the PRISM4 trial. The treatment did have positive data from a phase 2 placebo-controlled trial, as well as a phase 2 open-label trial for patients with recurrent CDI.

During Digestive Disease Week (DDW) 2022, Finch presented data from the open-label trial called the PRISM-EXT trial showing positive safety and efficacy results in 132 patients with at least 1 rCDI episode.

Data show the overall proportion of individuals with sustained clinical cure through week 8 was 80.3%, which was maintained at a sustained clinical cure rate of 78.8% through week 24 in a subset of patients who entered the trial directly after a first CDI recurrence.

For a group of patients who entered the open-label extension from PRISM3 CP101, data show 70% (n = 14) had a sustained clinical cure through week 8 after a second dose.

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%.

“These were very difficult decisions that we determined were necessary after carefully considering a number of factors and challenges facing Finch,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics, in a statement.