FDA News

FDA fast-tracks Finch’s microbiome capsule for C. difficile

Microbiome company Finch Therapeutics Group announced that the FDA has issued Fast Track designation to CP101, its oral microbiome capsule in development for recurrent Clostridium difficile infection.

The company also announced it has raised $36 million in Series B financing to support the clinical development of CP101 — which researchers are currently testing in a phase 2 study — as well as other clinical and preclinical programs. After this round of financing, the company has raised a total of $77 million in capital since its inception.

“This financing positions Finch to achieve key data and operational milestones as we advance our pipeline of novel microbiome-based therapies,” Mark Smith, PhD, CEO of Finch Therapeutics Group, said in a press release. “We look forward to continued progress in PRISM 3, our ongoing phase 2 study of CP101, an orally delivered Full-Spectrum Microbiota product being developed for recurrent C. difficile infections. We are also excited to advance our pipeline of therapeutic candidates into the clinic both through sponsored programs and in collaboration with Takeda and our academic partners as we work to realize the exciting potential of the human microbiome.”

“We’re pleased to increase our investment in Finch,” Chris Shumway of Shumway Capital said in the press release. “Beyond its innovative science and unique foundation of clinical data, we’re excited by Finch’s comprehensive intellectual property estate, which now includes 29 issued patents.”

As Healio Gastroenterology and Liver Disease previously reported, Finch merged with Crestovo in October 2017 to pool resources for the development of CP101.

Disclosures: Smith is employed by Finch Therapeutics Group.

Microbiome company Finch Therapeutics Group announced that the FDA has issued Fast Track designation to CP101, its oral microbiome capsule in development for recurrent Clostridium difficile infection.

The company also announced it has raised $36 million in Series B financing to support the clinical development of CP101 — which researchers are currently testing in a phase 2 study — as well as other clinical and preclinical programs. After this round of financing, the company has raised a total of $77 million in capital since its inception.

“This financing positions Finch to achieve key data and operational milestones as we advance our pipeline of novel microbiome-based therapies,” Mark Smith, PhD, CEO of Finch Therapeutics Group, said in a press release. “We look forward to continued progress in PRISM 3, our ongoing phase 2 study of CP101, an orally delivered Full-Spectrum Microbiota product being developed for recurrent C. difficile infections. We are also excited to advance our pipeline of therapeutic candidates into the clinic both through sponsored programs and in collaboration with Takeda and our academic partners as we work to realize the exciting potential of the human microbiome.”

“We’re pleased to increase our investment in Finch,” Chris Shumway of Shumway Capital said in the press release. “Beyond its innovative science and unique foundation of clinical data, we’re excited by Finch’s comprehensive intellectual property estate, which now includes 29 issued patents.”

As Healio Gastroenterology and Liver Disease previously reported, Finch merged with Crestovo in October 2017 to pool resources for the development of CP101.

Disclosures: Smith is employed by Finch Therapeutics Group.