Microbiome - October 2020
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CAR-T Digest - August 2020
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CAR-T Digest - August 2020
Microbiome - October 2020
Finch Therapeutics presented positive data from its pivotal Phase 2 trial of CP101 in recurrent C. difficile infections
13 Oct 2020
CP101 (GI microbiome modulator) – Finch Therapeutics
- Finch Therapeutics presented data at UEG week 2020
- Trial details:
- Pivotal Phase 2 (PRISM3); Patients with recurrence of C. difficile infection; N= 198; CP101 (6×10^11 cell count), PO or placebo; Primary endpoints: Sustained clinical cure rate, AEs; PCD: Feb’20; Active, not recruiting; Location: US, Canada
- Results:
- Out of 198 participants, 102 were administered CP101 while 96 were placebo-controlled
Endpoint
CP101 (n=102)
Placebo (n=96)
Sustained clinical cure rate
74.5% (76/102)
61.5% (59/96)
TEAEs
N/A
N/A
- Time-to-event analysis showed a statistically significant benefit, favouring CP101 compared to placebo (p=0.0139)
- CP101 resulted in the prevention of recurrence across a broad population, including patients with first CDI recurrence (27.5%) and diagnosis by any guideline approved CDI diagnostic method (62.7%)
- Out of 198 participants, 102 were administered CP101 while 96 were placebo-controlled
Finch Therapeutics to conduct confirmatory study to support PRISM3 results of CP101 in CDI
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CI Scientists Remarks:
- Finch Therapeutics is developing microbiome therapies using its Human-First Discovery platform and has created multiple product repositories of Full-Spectrum Microbiota (FSM) products And Rationally-Selected Microbiota (RSM) products
- CP101 the lead FSM candidate for prevention of CDI and has been granted fast track and break through designations by the FDA
- Even though CP101 met its primary efficacy endpoint in the pivotal trial, Finch therapeutics said the results were not good enough to support a regulatory submission and the molecule will be tested in a larger confirmatory trial
- In Sep’20, Finch received $90 million financing to advance its pipeline of investigational oral microbiome drugs. New investors in the round include Baupost Group, Humboldt Fund, MSD Capital, MSD Partners, Octave Group, and OMX Ventures, along with support from existing investors, including Avenir Growth Capital, OCV Partners, Shumway Capital, SIG, SymBiosis, TPTF, and Willett Advisors.
- Their microbiome portfolio includes:
Drug
Technology
Indication
Phase
CP101
FSM
Recurrent C. difficile infection
Phase 2
CP101
FSM
Chronic hepatitis B
Phase 1 planned
FIN-211
FSM
Autism spectrum disorder (ASD)
Phase 2
FIN-524 (Takeda)
RSM
Ulcerative collitis
Preclinical
FIN-525 (Takeda)
RSM
Crohn’s disease
Pre-clinical
– Tarun Raisinghani, CI Scientists