Associated tags: Obesity, Disease, T2D, AAV, DSM-IV codes, Pancreas, Pharmaceutical industry, Therapy, Diabetes, Health, Biotechnology, Type 2 diabetes, Research, Clinical Trials, Science, General Health, Other Science, Medical Devices, Gene, Weight loss, Insulin
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Medical device BURLINGTON, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced the appointment of Adrian Kimber as Chief Commercial Officer.
Key Points:
- BURLINGTON, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced the appointment of Adrian Kimber as Chief Commercial Officer.
- Mr. Kimber joins Fractyl with over two decades of experience in the biotechnology and medical devices sectors.
- Throughout his career, he has showcased a commendable history of introducing groundbreaking therapies to worldwide markets.
- “We are delighted to welcome Adrian to Fractyl, where his breadth of commercial and strategic leadership experience will be instrumental as we prepare for the launch of our Revita® system,” said Dr. Harith Rajagopalan, CEO of Fractyl Health.
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Pharmaceutical industry BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and obesity, today reported its fourth quarter and full year 2023 financial results and provided a business update.
Key Points:
- “In addition, we expect to complete enrollment of our pivotal Revitalize-1 study and are excited to report topline data in the fourth quarter of 2024.
- The Company expects to complete enrollment in the first half of 2024 and report topline data in the fourth quarter of 2024.
- In December 2023, Fractyl presented preclinical findings in an oral presentation at the World Congress of Insulin Resistance Diabetes and Cardiovascular Disease 2023 Annual Meeting.
- Cash Position: As of December 31, 2023, Fractyl had approximately $33.2 million in cash and cash equivalents.
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Pharmaceutical industry BURLINGTON, Mass., March 12, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced promising new preclinical findings for the first clinical candidate in its Rejuva® pancreatic gene therapy platform. RJVA-001 is the Company’s first GLP-1 gene therapy candidate to emerge from the platform, setting the stage for a potentially transformative approach to treating metabolic diseases, including obesity and T2D.
Key Points:
- Data provides first demonstration of glucose lowering and weight loss potency from pancreas-produced native human GLP-1, highlighting the capacity of pancreatic GLP-1 to provide metabolic control.
- These results with a native, short half-life human GLP-1 sequence to be used in RJVA-001 build upon earlier results with a prototype transgene GLP-1 analogue.
- RJVA-001 is the Company’s first GLP-1 gene therapy candidate to emerge from the platform, setting the stage for a potentially transformative approach to treating metabolic diseases, including obesity and T2D.
- The Company has reached alignment with European regulators on the use of this efficacy model to support the submission of a Clinical Trial Application (CTA) in Europe.
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Tuesday, February 20, 2024
"Sam Conaway's proven track record in the successful launch of novel products and therapeutic procedures is a critical addition to our Board of Directors at this juncture," said Dr. Harith Rajagopalan, Co-Founder and CEO of Fractyl Health.
Key Points:
- "Sam Conaway's proven track record in the successful launch of novel products and therapeutic procedures is a critical addition to our Board of Directors at this juncture," said Dr. Harith Rajagopalan, Co-Founder and CEO of Fractyl Health.
- Sales in the Cardiology Group at Boston Scientific Corporation and as Chairman of Close the Gap, the Boston Scientific Health Equity initiative.
- "I am deeply honored and excited to join the Board of Directors at Fractyl Health, a company at the cutting edge of addressing some of the most pressing healthcare challenges of our time," said Mr. Conaway.
- Mr. Conaway's expertise is expected to play a key role in Fractyl Health's ongoing efforts to complete its pivotal clinical studies in T2D and weight loss maintenance.
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Pharmaceutical industry LEXINGTON, Mass., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, a metabolic therapeutics company focused on pioneering new approaches for the treatment of T2D and obesity, announced the nomination of RJVA-001 as the first clinical T2D candidate in its Rejuva gene therapy platform. This milestone marks the Company’s first GLP-1 gene therapy candidate to emerge from the platform, setting the stage for a potentially transformative approach to treating metabolic diseases, including obesity and T2D.
Key Points:
- This milestone marks the Company’s first GLP-1 gene therapy candidate to emerge from the platform, setting the stage for a potentially transformative approach to treating metabolic diseases, including obesity and T2D.
- "Our goal is to drive a major advance in metabolic care by developing therapies that aim to eradicate T2D and obesity.
- We're excited by the potential of the Rejuva platform, led by RJVA-001, to redefine the treatment landscape for patients by offering sustained, physiologic GLP-1 from the pancreas.
- The Company anticipates completing IND-enabling studies, or its equivalent, for RJVA-001 in the second half of 2024.
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Monday, December 11, 2023
LEXINGTON, Mass., Dec. 11, 2023 (GLOBE NEWSWIRE) -- Fractyl Health, a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and obesity, presented preclinical findings from its Rejuva® gene therapy platform at the World Congress Insulin Resistance Diabetes and Cardiovascular Disease 2023 Annual Meeting. The oral presentation, titled “Single-dose GLP-1-based Pancreatic Gene Therapy Maintains Weight Loss After Semaglutide Withdrawal in a Murine Model of Obesity,” highlighted the promising implications of the Rejuva platform in providing a durable therapeutic solution for obesity with a GLP-1-based pancreatic gene therapy candidate (GLP-1 PGTx) designed to target the pancreas to provide long-term metabolic benefits from a single administration.
Key Points:
- During the oral presentation today, the company presented results from the well-validated DIO rodent model of obesity.
- GLP-1 PGTx demonstrated improved weight loss compared to semaglutide at day 28, with 27% weight loss for GLP-1 PGTx vs. 21% weight loss for semaglutide (p
- By Day 57, the semaglutide-withdrawn vehicle arm had regained 19% body weight to a total body weight loss of 2% from baseline, nearly eliminating all semaglutide-induced weight loss.
- The animals who crossed over from semaglutide to single-dose GLP-1 PGTx, however, lost additional body weight to a total body weight loss of 26% from vehicle, thereby maintaining semaglutide-induced weight loss.
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Thursday, November 16, 2023
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Pharmaceutical industry The new research, to be led by Professor Randy Seeley, Ph.D., of Michigan Medicine, is intended to explore the mechanistic rationale underlying the use of local pancreatic gene therapy to produce targeted treatment options that address, and hopefully remit, metabolic diseases.
Key Points:
- The new research, to be led by Professor Randy Seeley, Ph.D., of Michigan Medicine, is intended to explore the mechanistic rationale underlying the use of local pancreatic gene therapy to produce targeted treatment options that address, and hopefully remit, metabolic diseases.
- “T2D and obesity are two of society’s most vexing chronic diseases.
- We now have much better tools in the toolbox, but all rely on chronic therapy to achieve their benefits.
- “We are excited to deepen our scientific collaboration with Dr. Seeley to explore the metabolic mechanisms underpinning a one-time gene therapy in the pancreas.”
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Wednesday, October 4, 2023
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Vaccine During the oral presentation today, the company presented late-breaking results from an additional, second efficacy model of metabolic disease, the well-validated DIO rodent model of obesity.
Key Points:
- During the oral presentation today, the company presented late-breaking results from an additional, second efficacy model of metabolic disease, the well-validated DIO rodent model of obesity.
- A single dose of a GLP-1 PGTx was compared to chronic semaglutide 10 nmol/kg/day in a head-to-head study.
- GLP-1 PGTx demonstrated improved weight loss compared to semaglutide at day 15, with 24.8% weight loss for GLP-1 PGTx vs. 18.4% weight loss for semaglutide (p
- Both semaglutide and GLP-1 PGTx treatment arms saw reduced food intake compared to vehicles that persisted through day 15, providing a mechanistic explanation for the weight loss in these animals.
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Thursday, September 28, 2023
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T2D Fractyl Health, a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including type 2 diabetes (T2D) and obesity, announced today its upcoming abstract presentations at the European Association for the Study of Diabetes (EASD) 2023 Scientific Congress.
Key Points:
- Fractyl Health, a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including type 2 diabetes (T2D) and obesity, announced today its upcoming abstract presentations at the European Association for the Study of Diabetes (EASD) 2023 Scientific Congress.
- The congress will be held virtually and in person in Hamburg, Germany, from October 2-6, 2023.
- Fractyl Health is set to present noteworthy updates on its Revita® and Rejuva® programs.
- “We look forward to sharing our novel findings at the EASD Scientific Congress,” said Dr. Harith Rajagopalan, CEO of Fractyl Health.
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T2D “Here, a one-time administration of GLP1 PGTx in rodent models suggests we have a pathway to get there.
Key Points:
- “Here, a one-time administration of GLP1 PGTx in rodent models suggests we have a pathway to get there.
- The therapy is enabled by Fractyl’s development of both proprietary gene constructs and a proprietary delivery system, and leverages a decade of Fractyl research and device development.
- If we can protect the pancreas from failing, we can halt the progression of T2D.
- Fractyl’s PGTx is progressing through lead optimization and IND-enabling toxicity studies with the aim of first-in-human studies in 2024.
