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2 años hace
NEWS
Finch Therapeutics Announces Clinical Collaboration in Ulcerative Colitis with Brigham and Women’s Hospital and Updates to University of Minnesota License Agreement
SOMERVILLE, Mass., April 18, 2023 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“Finch”, “Finch Therapeutics” or the “Company”) (Nasdaq: FNCH), a microbiome technology company with a portfolio of intellectual property and microbiome assets, today announced that it has entered into a clinical trial agreement with Brigham and Women’s Hospital for the evaluation of CP101, a Complete Consortia microbiome therapeutic, in ulcerative colitis. The Company also announced updates to its license agreement with the University of Minnesota.
Under the clinical trial agreement, Brigham and Women’s Hospital will conduct an investigator-sponsored trial that is designed to compare two doses of CP101 in patients with mild-to-moderate ulcerative colitis. The study is designed to generate data on safety, pharmacokinetics, pharmacodynamics and clinical efficacy, and aims to build on a growing body of evidence supporting the role of the microbiome in improving outcomes for patients suffering from ulcerative colitis. Topline data from this clinical study is anticipated in 2025.
The Company also announced that it has amended its license agreement with the University of Minnesota, through which Finch has exclusively licensed 13 issued patents and 7 patent applications covering specific approaches to formulations comprising human fecal microbes, methods of increasing microbiota diversity, and methods of decreasing the relative abundance of certain bacteria. A key feature of the amendment allows Finch to satisfy certain performance milestones through sublicensing agreements, aligning with Finch’s new strategic focus on collaborations and partnerships.
“Today’s announcements reflect our continued progress executing against our strategy to build value and advance our microbiome technology through external partnerships,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “The clinical trial agreement to evaluate CP101 in ulcerative colitis builds on many years of work at Finch to develop product candidates to serve this important unmet medical need. We look forward to working with our collaborators at Brigham and Women’s Hospital to evaluate CP101 in this new clinical setting, where I believe an orally administered Complete Consortia product offers the potential to reset the pathophysiology of this disease. I am also pleased to extend our long-standing relationship with the University of Minnesota, which we believe positions us to continue to advance our microbiome technology through collaborations and partnerships.”
About CP101
CP101 is an investigational, orally administered microbiome therapeutic designed to deliver a diverse microbial community. CP101 is designed to address multiple therapeutic indications by restoring a diverse microbial community and key physiological pathways that are believed to be disrupted in multiple gut- and immune-related diseases.
About Finch Therapeutics
Finch Therapeutics is a microbiome technology company with a portfolio of intellectual property and microbiome assets. Finch has a robust intellectual property estate reflecting the Company’s pioneering role in the microbiome therapeutics field, including more than 70 issued U.S. and foreign patents with critical relevance for both donor-derived and donor-independent microbiome therapeutics in a range of potential indications. Finch’s assets include CP101, an investigational, orally administered microbiome candidate with positive clinical date from a Phase 2 randomized, placebo-controlled trial and a Phase 2 open-label trial in recurrent C. difficile infection (CDI). Additionally, Finch has pre-clinical assets that are designed to target ulcerative colitis, Crohn’s disease, and autism spectrum disorder, along with a significant biorepository of samples and microbial strains. In January 2023, Finch announced a decision to discontinue its Phase 3 trial of CP101 in recurrent CDI. Following this decision, Finch is focused on realizing the value of its intellectual property estate and other assets, while supporting the advancement of its microbiome technology through partnerships and collaborations.
Forward-Looking Statements:
This press release includes “forward-looking statements.” Words such as “will,” "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding: the outcome and timelines associated with the investigator-sponsored trial to be conducted with Brigham and Women’s Hospital and the ability of the investigator-sponsored trial to contribute to the body of evidence supporting the role of the microbiome in improving outcomes for patients suffering from ulcerative colitis; Finch’s ability to execute against its strategy to build value and advance its microbiome technology through external innovation, including collaborations and partnerships; the therapeutic potential of CP101 in ulcerative colitis; and the ability of the Company to advance its microbiome technology through collaborations and partnerships. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others, those related to: the possibility that Finch will not be able to realize the value of its intellectual property estate and other assets; Finch’s ability to comply with regulatory requirements; the possibility that Finch’s collaborators may be delayed in initiating, enrolling or completing clinical trials; results of clinical trials may not be indicative of final or future results from later stage or larger clinical trials (or in broader patient populations) or may not be favorable or may not support further development; product candidates developed using Finch’s microbiome technology may not generate the benefits to patients that are anticipated; and Finch’s ability to maintain patent and other intellectual property protection and the possibility that Finch’s intellectual property rights may be infringed, invalid or unenforceable or will be threatened by third parties. These and other risks are described more fully in Finch’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in Finch’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 23, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Finch’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Finch undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525-2047
stephen@gilmartinir.com
Media and Collaborator Contact:
info@finchtherapeutics.com
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subslover
2 años hace
Finch Therapeutics Presents PRISM-EXT Biomarker Data at ACG 2022 and Proceeds with Patient Dosing in Phase 3 Trial of CP101 in Recurrent C. Difficile Infection
October 24 2022 - 08:00AM
GlobeNewswire Inc.
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Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today announced the presentation of biomarker data from PRISM-EXT, a Phase 2 open-label trial of CP101 in recurrent C. difficile infection (CDI), at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting, being held October 21-26, 2022 in Charlotte, NC. Finch also announced today that the company has proceeded with patient dosing in PRISM4, a Phase 3 trial of CP101 for the prevention of recurrent CDI.
“This is an exciting time for Finch and the overall microbiome field, with hope and new potential therapeutic options on the horizon for patients fighting recurrent CDI,” said Howard Franklin, MD, MBA, Chief Medical Officer of Finch Therapeutics. “At ACG’s annual meeting, we are pleased to be presenting biomarker data from our PRISM-EXT trial showing that higher engraftment of CP101 microbes and an increase in intestinal microbiome diversity were both associated with prevention of recurrent CDI. These results further our understanding of the pharmacokinetics and pharmacodynamics of CP101 and support our efforts to optimize engraftment of CP101 microbes.”
Dr. Franklin continued, “We are also very pleased to be back in the clinic with CP101 and are deeply grateful to our PRISM4 study sites and study participants for their dedication to supporting the development of CP101. We will continue to work with urgency to advance CP101, an investigational microbiome therapeutic that we believe holds the promise of fulfilling the need for a convenient, one-time oral therapy that can break the cycle of CDI recurrence.”
The PRISM-EXT poster details are as follows:
Poster Title: 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 (E0096)
Presenting Author: Jessica R. Allegretti, MD, MPH, Brigham and Women's Hospital, Boston, MA and Harvard Medical School, Boston MA
Presentation Date and Time: Tuesday, October 25, 2022 at 3:00 pm ET
Following open-label administration of CP101 after standard-of-care (SOC) CDI antibiotics, there was a significant increase in microbiome diversity from baseline through week 8 and week 24 in PRISM-EXT participants.
Higher engraftment of CP101-associated taxa and improvement in diversity were both associated with prevention of CDI recurrence through week 8.
As previously reported, 80.3% and 78.8% of participants who received CP101 following SOC antibiotics in PRISM-EXT were without CDI recurrence through week 8 and week 24, respectively (n=132). The CP101 safety results from PRISM-EXT were consistent with previously reported results, with no treatment-related serious adverse events or deaths. The most frequent treatment-related adverse events were gastrointestinal symptoms of mild-moderate severity.
PRISM-EXT was a Phase 2, multi-center, open-label trial of CP101 for the prevention of recurrent CDI in adults with one or more CDI recurrences. The primary endpoints were safety and the proportion of participants without CDI recurrence through week 8. Participants were followed through week 24 for safety and CDI recurrence. Exploratory microbiome endpoints were measured at baseline following SOC antibiotics, week 8 and week 24 using 16S rRNA gene amplicon sequencing. A copy of the PRISM-EXT poster presented at ACG will be available on the ‘Publications’ page of the Finch website after the meeting.
About CP101
CP101 is an investigational microbiome therapeutic designed to deliver a diverse microbial community in a one-time oral administration, without the need for bowel preparation. CP101 is designed to enable prevention of recurrent C. difficile infection (CDI) by restoring a diverse microbial community and key physiological pathways that are believed to contribute to colonization resistance.
About the PRISM4 Phase 3 Trial
PRISM4 is a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial evaluating the efficacy and safety of a one-time oral administration of CP101 for the prevention of recurrent C. difficile infection (CDI). After completing standard-of-care CDI antibiotics for their most recent CDI recurrence, eligible participants will be randomized in a 2:1 ratio to receive either CP101 or placebo. Participants will be evaluated for CDI recurrence and safety through week 8, the primary endpoint, as well as through week 24. Participants who qualify may enroll in the optional open label arm and receive CP101 if they experience a CDI recurrence through week 8 of the trial. To learn more about the trial, visit clinicaltrials.gov (Identifier: NCT05153499) or the study website at https://prism4trial.com/.
subslover
2 años hace
Finch Therapeutics Presents PRISM-EXT Biomarker Data at ACG 2022 and Proceeds with Patient Dosing in Phase 3 Trial of CP101 in Recurrent C. Difficile Infection
October 24 2022 - 08:00AM
GlobeNewswire Inc.
Alert
Print
Share On Facebook
Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today announced the presentation of biomarker data from PRISM-EXT, a Phase 2 open-label trial of CP101 in recurrent C. difficile infection (CDI), at the American College of Gastroenterology (ACG) 2022 Annual Scientific Meeting, being held October 21-26, 2022 in Charlotte, NC. Finch also announced today that the company has proceeded with patient dosing in PRISM4, a Phase 3 trial of CP101 for the prevention of recurrent CDI.
“This is an exciting time for Finch and the overall microbiome field, with hope and new potential therapeutic options on the horizon for patients fighting recurrent CDI,” said Howard Franklin, MD, MBA, Chief Medical Officer of Finch Therapeutics. “At ACG’s annual meeting, we are pleased to be presenting biomarker data from our PRISM-EXT trial showing that higher engraftment of CP101 microbes and an increase in intestinal microbiome diversity were both associated with prevention of recurrent CDI. These results further our understanding of the pharmacokinetics and pharmacodynamics of CP101 and support our efforts to optimize engraftment of CP101 microbes.”
Dr. Franklin continued, “We are also very pleased to be back in the clinic with CP101 and are deeply grateful to our PRISM4 study sites and study participants for their dedication to supporting the development of CP101. We will continue to work with urgency to advance CP101, an investigational microbiome therapeutic that we believe holds the promise of fulfilling the need for a convenient, one-time oral therapy that can break the cycle of CDI recurrence.”
The PRISM-EXT poster details are as follows:
Poster Title: 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 (E0096)
Presenting Author: Jessica R. Allegretti, MD, MPH, Brigham and Women's Hospital, Boston, MA and Harvard Medical School, Boston MA
Presentation Date and Time: Tuesday, October 25, 2022 at 3:00 pm ET
Following open-label administration of CP101 after standard-of-care (SOC) CDI antibiotics, there was a significant increase in microbiome diversity from baseline through week 8 and week 24 in PRISM-EXT participants.
Higher engraftment of CP101-associated taxa and improvement in diversity were both associated with prevention of CDI recurrence through week 8.
As previously reported, 80.3% and 78.8% of participants who received CP101 following SOC antibiotics in PRISM-EXT were without CDI recurrence through week 8 and week 24, respectively (n=132). The CP101 safety results from PRISM-EXT were consistent with previously reported results, with no treatment-related serious adverse events or deaths. The most frequent treatment-related adverse events were gastrointestinal symptoms of mild-moderate severity.
PRISM-EXT was a Phase 2, multi-center, open-label trial of CP101 for the prevention of recurrent CDI in adults with one or more CDI recurrences. The primary endpoints were safety and the proportion of participants without CDI recurrence through week 8. Participants were followed through week 24 for safety and CDI recurrence. Exploratory microbiome endpoints were measured at baseline following SOC antibiotics, week 8 and week 24 using 16S rRNA gene amplicon sequencing. A copy of the PRISM-EXT poster presented at ACG will be available on the ‘Publications’ page of the Finch website after the meeting.
About CP101
CP101 is an investigational microbiome therapeutic designed to deliver a diverse microbial community in a one-time oral administration, without the need for bowel preparation. CP101 is designed to enable prevention of recurrent C. difficile infection (CDI) by restoring a diverse microbial community and key physiological pathways that are believed to contribute to colonization resistance.
About the PRISM4 Phase 3 Trial
PRISM4 is a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial evaluating the efficacy and safety of a one-time oral administration of CP101 for the prevention of recurrent C. difficile infection (CDI). After completing standard-of-care CDI antibiotics for their most recent CDI recurrence, eligible participants will be randomized in a 2:1 ratio to receive either CP101 or placebo. Participants will be evaluated for CDI recurrence and safety through week 8, the primary endpoint, as well as through week 24. Participants who qualify may enroll in the optional open label arm and receive CP101 if they experience a CDI recurrence through week 8 of the trial. To learn more about the trial, visit clinicaltrials.gov (Identifier: NCT05153499) or the study website at https://prism4trial.com/.
crudeoil24
3 años hace
Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Finch’s investigational new drug (IND) application for CP101. CP101 is the Company’s investigational orally administered microbiome therapeutic which is in late-stage clinical development for the prevention of recurrent C. difficile infection (CDI). The FDA lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.
“We are grateful that the FDA has completed its review of the information we provided, and we are pleased that the clinical hold on our CP101 IND has been lifted,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “We look forward to completing the additional activities that we believe will enable us to proceed with enrollment in PRISM4, our Phase 3 study of CP101 in recurrent C. difficile infection, and we thank our PRISM4 trial partners for their continued support and dedication to serving patients who are battling recurrent C. difficile infection.”
Finch expects to proceed with enrollment in PRISM4 after it completes certain manufacturing activities and quality system updates related to the recently resolved clinical hold, and submits for the FDA’s review and agreement the validation package for one of its release tests and a PRISM4 protocol amendment. The PRISM4 protocol amendment will implement changes to the algorithm used to diagnose suspected CDI recurrences and revisions to the planned statistical analysis. In parallel with these activities, Finch will continue to work with its PRISM4 trial sites to prepare for enrollment.
Finch plans to provide an update on the anticipated timing of both its PRISM4 trial and its planned AUSPIRE Phase 1b trial of FIN-211 in children with autism spectrum disorder and significant gastrointestinal symptoms when the Company reports its first quarter 2022 results.
About Finch Therapeutics
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs. With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for the prevention of recurrent C. difficile infection and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. Finch is also developing FIN-211 for children with autism spectrum disorder and significant gastrointestinal symptoms. Finch has a partnership with Takeda focused on the development of targeted microbiome therapeutics for inflammatory bowel disease.
Human-First Discovery® is a registered trademark of Finch Therapeutics Group, Inc.
Forward-Looking Statements:
This press release includes “forward-looking statements”. Words such as “will,” “anticipates,” “believes,” “expects,” “intends,” “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding Finch’s ability to complete additional activities to enable it to proceed with enrollment in PRISM4, including completion of certain manufacturing activities and quality system updates and submission to the FDA’s satisfaction of a PRISM4 protocol amendment and the validation package for one of its release tests, its ability to continue working with PRISM4 trial sites to prepare for enrollment and its plans to provide an update on the timing of the PRISM4 trial and the AUSPIRE trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: the risk that correspondence from the FDA may require Finch to collect additional data or information beyond what it currently expects; uncertainties relating to regulatory applications and related filing and approval timelines; Finch’s limited operating history and historical losses; the possibility that Finch may be delayed in initiating, enrolling or completing any clinical trials; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; the ability of Finch to comply with regulatory requirements or experience unanticipated problems with any of its product candidates; ongoing regulatory obligations and continued regulatory review may result in significant additional expense to Finch and Finch may be subject to penalties for failure to comply; Finch’s ability to maintain patent and other intellectual property protection and the possibility that Finch’s intellectual property rights may be infringed, invalid or unenforceable or will be threatened by third parties; Finch’s ability to qualify and scale its manufacturing capabilities to support multiple global clinical trials; Finch’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and risks relating to the impact and duration of the COVID-19 pandemic on Finch’s business. These and other risks are described more fully in Finch’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in Finch’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 31, 2022, as well as discussions of potential risks, uncertainties, and other important factors in Finch’s other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Finch undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525-2047
stephen@gilmartinir.com
subslover
3 años hace
Finch Therapeutics Announces Removal of FDA Clinical Hold on CP101 IND
SOMERVILLE, Mass., April 28, 2022 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Finch’s investigational new drug (IND) application for CP101. CP101 is the Company’s investigational orally administered microbiome therapeutic which is in late-stage clinical development for the prevention of recurrent C. difficile infection (CDI). The FDA lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.
“We are grateful that the FDA has completed its review of the information we provided, and we are pleased that the clinical hold on our CP101 IND has been lifted,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “We look forward to completing the additional activities that we believe will enable us to proceed with enrollment in PRISM4, our Phase 3 study of CP101 in recurrent C. difficile infection, and we thank our PRISM4 trial partners for their continued support and dedication to serving patients who are battling recurrent C. difficile infection.”
Finch expects to proceed with enrollment in PRISM4 after it completes certain manufacturing activities and quality system updates related to the recently resolved clinical hold, and submits for the FDA’s review and agreement the validation package for one of its release tests and a PRISM4 protocol amendment. The PRISM4 protocol amendment will implement changes to the algorithm used to diagnose suspected CDI recurrences and revisions to the planned statistical analysis. In parallel with these activities, Finch will continue to work with its PRISM4 trial sites to prepare for enrollment.
Finch plans to provide an update on the anticipated timing of both its PRISM4 trial and its planned AUSPIRE Phase 1b trial of FIN-211 in children with autism spectrum disorder and significant gastrointestinal symptoms when the Company reports its first quarter 2022 results.
About Finch Therapeutics
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs. With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for the prevention of recurrent C. difficile infection and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. Finch is also developing FIN-211 for children with autism spectrum disorder and significant gastrointestinal symptoms. Finch has a partnership with Takeda focused on the development of targeted microbiome therapeutics for inflammatory bowel disease.
Human-First Discovery® is a registered trademark of Finch Therapeutics Group, Inc.
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