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- || full spectrum microbiota (CP101) / Finch Therap
P2 data, Journal: Safety and Tolerability of CP101, a full spectrum, oral microbiome therapeutic for the prevention of recurrent C. difficile infection: A Phase 2 Randomized Controlled Trial. (Pubmed Central) - Oct 5, 2024
P2
CP101 was superior to placebo in reducing recurrent CDI with a safety profile similar to placebo. https://clinicaltrials.gov/study/NCT03110133.
- | full spectrum microbiota (CP101) / Finch Therap
Enrollment open: CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - Nov 30, 2023
P1, N=30, Recruiting, Sponsor: Brigham and Women's Hospital
https://clinicaltrials.gov/study/NCT03110133. Not yet recruiting --> Recruiting
- | full spectrum microbiota (CP101) / Finch Therap
Trial primary completion date: CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - Sep 6, 2023
P1, N=30, Not yet recruiting, Sponsor: Brigham and Women's Hospital
Not yet recruiting --> Recruiting Trial primary completion date: Apr 2025 --> Dec 2024
- | full spectrum microbiota (CP101) / Finch Therap
Trial initiation date: CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - Jul 28, 2023
P1, N=30, Not yet recruiting, Sponsor: Brigham and Women's Hospital
Trial primary completion date: Apr 2025 --> Dec 2024 Initiation date: Jun 2023 --> Sep 2023
- | full spectrum microbiota (CP101) / Finch Therap
New P1 trial: CP101 for the Treatment of Ulcerative Colitis (clinicaltrials.gov) - May 10, 2023
P1, N=30, Not yet recruiting, Sponsor: Brigham and Women's Hospital
- ||| full spectrum microbiota (CP101) / Finch Therap
Trial completion date, Trial termination, Trial primary completion date: A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - Feb 28, 2023
P3, N=19, Terminated, Sponsor: Finch Research and Development LLC.
Initiation date: Jun 2023 --> Sep 2023 Trial completion date: Oct 2024 --> Feb 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2024 --> Feb 2023; The termination of FIN-CDI-301 (PRISM4) is based on the voluntary, business-related decision of the sponsor.
- ||||| full spectrum microbiota (CP101) / Finch Therap
Enrollment closed, Enrollment change: A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - Jan 26, 2023
P3, N=19, Active, not recruiting, Sponsor: Finch Research and Development LLC.
Trial completion date: Oct 2024 --> Feb 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2024 --> Feb 2023; The termination of FIN-CDI-301 (PRISM4) is based on the voluntary, business-related decision of the sponsor. Recruiting --> Active, not recruiting | N=324 --> 19
- |||| full spectrum microbiota (CP101) / Finch Therap
Trial completion date, Trial primary completion date: A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - Dec 13, 2022
P3, N=324, Recruiting, Sponsor: Finch Research and Development LLC.
Recruiting --> Active, not recruiting | N=324 --> 19 Trial completion date: Dec 2023 --> Oct 2024 | Trial primary completion date: Feb 2023 --> Jan 2024
- |||||| full spectrum microbiota (CP101) / Finch Therap
Enrollment open: A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - Oct 5, 2022
P3, N=324, Recruiting, Sponsor: Finch Research and Development LLC.
Trial completion date: Dec 2023 --> Oct 2024 | Trial primary completion date: Feb 2023 --> Jan 2024 Active, not recruiting --> Recruiting
- full spectrum microbiota (CP101) / Finch Therap
Evaluation of Engraftment and Diversity Following Open-Label Administration of CP101, an Investigational Oral Microbiome Therapeutic for the Prevention of Recurrent C. difficile Infection, in the PRISM-EXT Trial (Crown Ballroom) - Sep 4, 2022 - Abstract #ACG2022ACG_1628;
No treatment-related serious adverse events were reported. Microbiome analysis showed that diversity significantly increased from baseline through Week 8 (p< 0.0001) and Week 24 (p< 0.0001, Fig 1A).
- ||| full spectrum microbiota (CP101) / Finch Therap
Trial completion, Enrollment change: PRISM-EXT: Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota (clinicaltrials.gov) - Aug 30, 2022
P2, N=132, Completed, Sponsor: Finch Research and Development LLC.
Microbiome analysis showed that diversity significantly increased from baseline through Week 8 (p< 0.0001) and Week 24 (p< 0.0001, Fig 1A). Active, not recruiting --> Completed | N=70 --> 132
- full spectrum microbiota (CP101) / Finch Therap
CP101, AN INVESTIGATIONAL MICROBIOME THERAPEUTIC FOR THE PREVENTION OF RECURRENT C. DIFFICILE INFECTION: A COMBINED ANALYSIS OF THE PRISM3 (RANDOMIZED PLACEBO-CONTROLLED) AND PRISM-EXT (OPEN-LABEL) TRIALS (Poster Hall - San Diego Convention Center) - Apr 25, 2022 - Abstract #DDW2022DDW_5916;
In this post-hoc analysis, the cumulative sustained clinical cure rate of CP101 changed from 74.5% in PRISM3 to 85.0% across both studies through Week 8. Notably, among participants that received CP101 in PRISM3, inclusive of those that rolled over to PRISM-EXT and received a second dose, the cumulative cure rate assessed in this post-hoc analysis was 88.2%.
- full spectrum microbiota (CP101) / Finch Therap
CP101, AN INVESTIGATIONAL ORALLY ADMINISTERED MICROBIOME THERAPEUTIC, WAS EFFECTIVE FOR PREVENTION OF RECURRENT C. DIFFICILE INFECTION: RESULTS FROM OPEN-LABEL PRISM-EXT TRIAL (20CD - San Diego Convention Center) - Apr 25, 2022 - Abstract #DDW2022DDW_3924;
Conclusion In PRISM-EXT, CP101 prevented recurrence of CDI through Week 8 which was sustained through Week 24 with no treatment-related serious adverse events, consistent with previously reported data from the randomized, placebo-controlled PRISM3 trial. The PRISM-EXT Results also suggest that a second dose of CP101 successfully rescued a significant proportion of participants who did not respond to an initial dose of CP101.
- ||||| full spectrum microbiota (CP101) / Finch Therap
Enrollment closed: A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - Mar 2, 2022
P3, N=324, Active, not recruiting, Sponsor: Finch Research and Development LLC.
The PRISM-EXT Results also suggest that a second dose of CP101 successfully rescued a significant proportion of participants who did not respond to an initial dose of CP101. Recruiting --> Active, not recruiting
- |||||||||| full spectrum microbiota (CP101) / Finch Therap
New P3 trial: A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (clinicaltrials.gov) - Dec 10, 2021
P3, N=324, Recruiting, Sponsor: Finch Research and Development LLC.
- full spectrum microbiota (CP101) / Finch Therap
CP101, an Investigational Orally Administered Microbiome Therapeutic, Increases Intestinal Microbiome Diversity and Prevents Recurrent C. difficile Infection: Results From a Randomized, Placebo-Controlled Trial (Mandalay Bay Ballroom EF) - Sep 8, 2021 - Abstract #ACG2021ACG_3627;
Alpha diversity was low in the CP101 and placebo arms at baseline, and similar between both groups. Participants treated with CP101 achieved significantly higher alpha diversity compared to placebo, and the increase in diversity was rapid and sustained over time (p< 0.001 at Week 1, p< 0.0001 at Week 8) (Fig.
- full spectrum microbiota (CP101) / Finch Therap
Week 24 Efficacy and Safety Data from PRISM3: A Randomized, Placebo-Controlled Trial Evaluating CP101, an Investigational Orally Administered Microbiome Therapeutic for the Prevention of Recurrent C. difficile Infection (Shoreline Exhibit Hall) - Sep 8, 2021 - Abstract #ACG2021ACG_1999;
Baseline characteristics were similar between CP101 (n=102) and placebo (n=96) arms. As previously reported, the CP101 arm demonstrated a statistically significant and clinically meaningful improvement in sustained clinical cure compared to the placebo arm through Week 8.
- full spectrum microbiota (CP101) / Finch Therap
CP101 Engraftment Drives Efficacy: Results From a Randomized, Placebo-Controlled Trial Evaluating CP101, an Investigational Orally Administered Microbiome Therapeutic for Prevention of Recurrent C. difficile Infection (Shoreline Exhibit Hall) - Sep 8, 2021 - Abstract #ACG2021ACG_1422;
Participants treated with CP101 had significantly higher engraftment of CP101-associated taxa compared to placebo (Fig. 1a), and engraftment was both rapid and sustained over time (p< 0.0001 at Week 1, p< 0.0001 at Week 8).
- ||||| full spectrum microbiota (CP101) / Finch Therap, SER-109 / Seres Therap, RBX2660 / Ferring
P2 data, P3 data: 2/2 ➡️FMT is promising for #Cdiff in IBD with high success rates and few AEs ➡️SER-109 @SeresTX and RBX2660 @Rebiotix have positive Phase III data for Cdiff ➡️CP101 @finch_tx has positive phase II data and RBX7455 has positive phase I data (Twitter) - Jul 20, 2021
- | full spectrum microbiota (CP101) / Finch Therap
Enrollment change, Trial withdrawal: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT) (clinicaltrials.gov) - Apr 22, 2021
P2, N=0, Withdrawn, Sponsor: Finch Research and Development LLC.
1a), and engraftment was both rapid and sustained over time (p< 0.0001 at Week 1, p< 0.0001 at Week 8). N=50 --> 0 | Not yet recruiting --> Withdrawn
- |||| full spectrum microbiota (CP101) / Finch Therap
Trial completion: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff (clinicaltrials.gov) - Jan 11, 2021
P2, N=206, Completed, Sponsor: Finch Research and Development LLC.
N=50 --> 0 | Not yet recruiting --> Withdrawn Active, not recruiting --> Completed
- || full spectrum microbiota (CP101) / Finch Therap
Enrollment closed: PRISM-EXT: Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota (clinicaltrials.gov) - Jan 11, 2021
P2, N=70, Active, not recruiting, Sponsor: Finch Research and Development LLC.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- full spectrum microbiota (CP101) / Finch Therap
[VIRTUAL] An Investigational Oral Microbiome Drug, CP101, for the Prevention of Recurrent C. difficile Infection: A Randomized, Placebo-Controlled, Multi-Center Trial (PRISM3) () - Oct 11, 2020 - Abstract #ACG2020ACG_3585;
Following any SOC antibiotic course, CP101 resulted in a significant and clinically meaningful reduction in recurrent CDI compared to placebo. Importantly, CP101 resulted in the prevention of recurrence across a broad population, including patients with first CDI recurrence and diagnosis by any guideline approved CDI diagnostic method.
- full spectrum microbiota (CP101) / Finch Therap
[VIRTUAL] AN INVESTIGATIONAL ORAL MICROBIOME DRUG, CP101, FOR THE PREVENTION OF RECURRENT C. DIFFICILE INFECTION: A RANDOMIZED, PLACEBO-CONTROLLED, MULTI-CENTER TRIAL (PRISM3) (Hall 2) - Sep 26, 2020 - Abstract #UEGW2020UEGW_6512;
Following any SOC antibiotic course, CP101 resulted in a significant and clinically meaningful reduction in recurrent CDI compared to placebo. Importantly, CP101 resulted in the prevention of recurrence across a broad population, including patients with first CDI recurrence and diagnosis by any guideline approved CDI diagnostic method.
- || full spectrum microbiota (CP101) / Finch Therap
Enrollment status, Trial completion date, Trial primary completion date: PRISM-EXT: Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota (clinicaltrials.gov) - Aug 8, 2020
P2, N=70, Recruiting, Sponsor: Finch Research and Development LLC.
Importantly, CP101 resulted in the prevention of recurrence across a broad population, including patients with first CDI recurrence and diagnosis by any guideline approved CDI diagnostic method. Enrolling by invitation --> Recruiting | Trial completion date: Aug 2020 --> Apr 2021 | Trial primary completion date: Feb 2020 --> Dec 2020
- || full spectrum microbiota (CP101) / Finch Therap
Enrollment closed: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff (clinicaltrials.gov) - Jan 9, 2020
P2, N=200, Active, not recruiting, Sponsor: Finch Research and Development LLC.
Enrolling by invitation --> Recruiting | Trial completion date: Aug 2020 --> Apr 2021 | Trial primary completion date: Feb 2020 --> Dec 2020 Recruiting --> Active, not recruiting
- | full spectrum microbiota (CP101) / Finch Therap
Trial completion date: PRISM-EXT: Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota (clinicaltrials.gov) - Aug 19, 2019
P2, N=70, Enrolling by invitation, Sponsor: Finch Research and Development LLC.
Recruiting --> Active, not recruiting Trial completion date: May 2020 --> Aug 2020
- | full spectrum microbiota (CP101) / Finch Therap
Trial completion date, Trial primary completion date: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff (clinicaltrials.gov) - Aug 19, 2019
P2, N=200, Recruiting, Sponsor: Finch Research and Development LLC.
Trial completion date: May 2020 --> Aug 2020 Trial completion date: Nov 2019 --> Jun 2020 | Trial primary completion date: Jul 2019 --> Dec 2019
- | full spectrum microbiota (CP101) / Finch Therap
Trial completion date, Trial initiation date, Trial primary completion date: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT) (clinicaltrials.gov) - Jun 20, 2019
P2, N=50, Not yet recruiting, Sponsor: Finch Research and Development LLC.
Trial completion date: Nov 2019 --> Jun 2020 | Trial primary completion date: Jul 2019 --> Dec 2019 Trial completion date: Apr 2021 --> Dec 2021 | Initiation date: Oct 2019 --> May 2020 | Trial primary completion date: Oct 2020 --> May 2020
- || full spectrum microbiota (CP101) / Finch Therap
New P2 trial: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT) (clinicaltrials.gov) - Feb 4, 2019
P2, N=50, Not yet recruiting, Sponsor: Finch Research and Development LLC.
- | full spectrum microbiota (CP101) / Finch Therap
Enrollment open: PRISM-EXT: Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota (clinicaltrials.gov) - Aug 6, 2018
P2, N=70, Enrolling by invitation, Sponsor: Finch Research and Development LLC.
Trial completion date: Apr 2021 --> Dec 2021 | Initiation date: Oct 2019 --> May 2020 | Trial primary completion date: Oct 2020 --> May 2020 Not yet recruiting --> Enrolling by invitation
- ||||| full spectrum microbiota (CP101) / Finch Therap
New P2 trial: PRISM-EXT: Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota (clinicaltrials.gov) - Apr 12, 2018
P2, N=70, Not yet recruiting, Sponsor: Finch Research and Development LLC.
- | full spectrum microbiota (CP101) / Finch Therap
Trial completion date, Trial primary completion date: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff (clinicaltrials.gov) - Apr 10, 2018
P2, N=200, Recruiting, Sponsor: Finch Research and Development LLC.
Not yet recruiting --> Enrolling by invitation Trial completion date: May 2019 --> Nov 2019 | Trial primary completion date: Dec 2018 --> Jul 2019
- | full spectrum microbiota (CP101) / Finch Therap
Enrollment open: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff (clinicaltrials.gov) - May 11, 2017
P2, N=240, Recruiting, Sponsor: Crestovo LLC
Trial completion date: May 2019 --> Nov 2019 | Trial primary completion date: Dec 2018 --> Jul 2019 Not yet recruiting --> Recruiting
- | full spectrum microbiota (CP101) / Finch Therap
New P2 trial: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff (clinicaltrials.gov) - Apr 12, 2017
P2, N=240, Not yet recruiting, Sponsor: Crestovo LLC