Glucokinase activator
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vTv Therapeutics Announces New Appointments to its Scientific Advisory Board
Globenewswire· 2025-10-09 12:00
Core Insights - vTv Therapeutics has appointed a distinguished Scientific Advisory Board (SAB) to guide the clinical development of cadisegliatin for type 1 diabetes, which is currently in Phase 3 trials [1][2][4] Company Overview - vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates for diabetes and other chronic diseases, with cadisegliatin as its lead candidate [7] Scientific Advisory Board - The SAB includes experts in endocrinology and diabetes research, such as Dr. John Buse, Dr. Alfonso Galderisi, Dr. Mark Evans, Dr. Chantal Mathieu, Dr. Alexander Fleming, and Dr. Klara Klein, who will provide strategic guidance on clinical trial planning and regulatory strategy [2][8] Cadisegliatin Details - Cadisegliatin (TTP399) is a novel oral small molecule that acts as a liver-selective glucokinase activator, being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes [5][6]
vTv Therapeutics Announces $80 Million Private Placement with Leading Healthcare Institutional Investors and the T1D Fund
Globenewswire· 2025-09-02 12:00
Core Viewpoint - vTv Therapeutics Inc. has announced an $80 million private placement financing to support the ongoing development of cadisegliatin, a potential first-in-class oral adjunctive therapy for type 1 diabetes, with topline data from the CATT1 Phase 3 trial expected in the second half of 2026 [1][4]. Financing Details - The PIPE financing involves existing and new investors, including Samsara BioCapital, the T1D Fund, Trails Edge Capital Partners, and Invus [2]. - The financing will consist of 682,018 shares of Class A Common Stock and pre-funded warrants to purchase 4,561,714 shares, with accompanying warrants for an aggregate of 5,243,732 shares [3]. - The purchase price for a unit of Class A Common Stock and accompanying warrant is $15.265, while the pre-funded warrant unit is priced at $15.255, with an exercise price of $22.71 per share for the accompanying warrants [3]. Product Development - The funding will facilitate the advancement of cadisegliatin through the CATT1 trial, which aims to evaluate its potential to reduce hypoglycemic events and improve glycemic control in individuals with type 1 diabetes [4]. - Cadisegliatin is a liver-selective glucokinase activator that has received Breakthrough Therapy designation from the U.S. FDA, indicating its potential significance in treating type 1 diabetes [8][9]. Company Overview - vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral small molecule drug candidates for diabetes and other chronic diseases, with cadisegliatin as its leading candidate currently in Phase 3 trials [10].
vTv Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-12 20:15
Core Viewpoint - vTv Therapeutics Inc. is advancing its late-stage biopharmaceutical candidate cadisegliatin, aimed at treating type 1 diabetes, with recent developments including the initiation of a Phase 3 trial and financial results indicating ongoing investment in research and development [2][3][5]. Recent Company Highlights - The first participant has been randomized in the CATT1 Phase 3 trial for cadisegliatin, with topline data expected in the second half of 2026 [6][7]. - The intellectual property portfolio for cadisegliatin has been expanded, with a patent application for crystalline forms allowed, extending the patent term through 2041 [7]. - Michael Tung has been appointed as Chief Financial Officer, bringing over 20 years of experience in financial management and strategic leadership [7]. Second Quarter 2025 Financial Results - As of June 30, 2025, the company's cash position was $25.9 million, down from $36.7 million at the end of 2024 [7]. - Research and Development (R&D) expenses increased to $4.1 million from $3.4 million in the same quarter of 2024, primarily due to higher payroll costs [7]. - General and Administrative (G&A) expenses decreased slightly to $3.6 million from $3.7 million year-over-year [7]. - The net loss attributable to vTv shareholders for the quarter was $6.0 million, or $0.92 per share, compared to a net loss of $5.2 million, or $0.81 per share, in the same period last year [8][12].
vTv Therapeutics Announces First Study Participant Randomized in CATT1 Phase 3 Trial of Cadisegliatin in Type 1 Diabetes
Globenewswire· 2025-08-07 12:00
Core Insights - vTv Therapeutics Inc. has initiated the CATT1 Phase 3 trial for cadisegliatin, an oral glucokinase activator for type 1 diabetes, with topline results expected in the second half of 2026 [1][2] - The trial aims to enroll approximately 150 participants across 25 sites in the U.S., evaluating the efficacy and safety of cadisegliatin compared to placebo [2][4] - Cadisegliatin has received Breakthrough Therapy designation from the FDA and has shown good tolerability in over 500 subjects [1][2] Company Overview - vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral small molecule drug candidates for diabetes and other chronic diseases [6] - The company's lead program, cadisegliatin, is being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes [6] Industry Context - There is a significant unmet need for therapeutic advances in type 1 diabetes, as current medical devices have not been complemented by effective oral adjunct therapies [2][3] - The introduction of glucokinase activators like cadisegliatin could potentially improve glycemic control while reducing the risks of hypoglycemia and diabetic ketoacidosis [3][4]
vTv Therapeutics Announces Reinitiation of Screening in CATT1 Phase 3 Trial Evaluating Potential First-in-Class Liver-Selective Glucokinase Activator Cadisegliatin for Type 1 Diabetes
Globenewswire· 2025-05-15 16:00
Core Viewpoint - vTv Therapeutics has resumed its CATT1 Phase 3 trial for cadisegliatin, an oral treatment for type 1 diabetes, with topline data expected in the second half of 2026 [2][3]. Group 1: Trial Details - The CATT1 Phase 3 trial duration has been shortened from 12 months to 6 months through a protocol amendment, expediting the timeline for topline data without affecting key study endpoints [3][4]. - The trial will enroll approximately 150 patients aged 18 and older at 20-25 sites in the U.S., comparing two doses of cadisegliatin against a placebo [4]. - Continuous glucose monitors will be provided to all participants to assess the primary efficacy endpoint, which focuses on the incidence of level 2 and level 3 hypoglycemic events [3][4]. Group 2: Product Information - Cadisegliatin (TTP399) is a novel, liver-selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes [5]. - Non-clinical studies indicate that cadisegliatin enhances glucokinase activity independently of insulin, suggesting potential improvements in glycemic control [5]. Group 3: Company Overview - vTv Therapeutics Inc. is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates, with cadisegliatin as its lead program for type 1 diabetes [7].