Cadisegliatin

Plus, news about vTv Therapeutics, Dynavax, Aura Biosciences and ArkBio: FDA lifts hold on Scynexis’ Phase 3 fungal infection trial: The agency concluded last month that the MARIO trial of ibrexafungerp in invasive candidiasis can continue, according to Scynexis. But the future of the program is uncertain because Scynexis’ partner GSK said it planned to terminate the study right after the agency lifted the hold — a decision the biotech is disputing. — Ayisha Sharma Incyte’s Zynyz wins FDA label expansion for rare anal cancer: The PD-1 drug is now approved in combination with platinum-based chemotherapy for first-line locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for SCAC patients who have progressed on or are intolerant to platinum-based chemotherapy. Zynyz secured its first FDA approval for a rare form of skin cancer two years ago. — Ayisha Sharma vTv Therapeutics restarts type 1 diabetes trial: The High Point, NC-based biotech started screening patients for a Phase 3 trial of cadisegliatin under an amended protocol. In March, the FDA lifted a clinical hold that had been placed on the study in 2024 after vTv reported a safety signal in a human absorption, distribution, metabolism and excretion study. The topline data are now expected in the second half of 2026. — Ayisha Sharma Activist investor ups pressure on Dynavax: Deep Track Capital penned a letter slamming Dynavax for “slowing market share growth” for its “crown jewel” hepatitis B vaccine Heplisav, failure to hit certain sales targets and its steadily declining share price $DVAX , which is down about 27% since the start of the year. The investment firm continued to urge the biotech to add four of its directors to the Dynavax board. — Ayisha Sharma Aura Biosciences’ $75M offering: The company said Thursday that the combined offering price of pre-funded warrants and common stocks is about $4.90 apiece. Its stock $AURA was up about 5% on Friday morning. — Jaimy Lee ArkBio’s idiopathic pulmonary fibrosis drug passes Phase 2: The 400 mg dose of the Shanghai biotech’s anti-fibrotic drug AK3280 produced a “statistically significant” improvement from baseline in a lung function test called forced vital capacity compared with placebo. The Phase 2 proof-of-concept trial was conducted across 31 sites in China. — Ayisha Sharma

Cadisegliatin has the potential to be the first oral adjunct therapy for type 1 diabetes CATT1 Phase 3 trial expected to resume following submission of protocol amendment shortening the overall duration of the trial from 12 to 6 months March 17, 2025 -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes (T1D), today announced that the United States Food and Drug Administration (FDA) has lifted the clinical hold on the cadisegliatin clinical program, which includes the CATT1 Phase 3 trial in type 1 diabetes (T1D). Cadisegliatin is an oral, liver-selective glucokinase activator that has been generally well tolerated in over 500 subjects to date with up to six months of treatment. vTv Therapeutics expects to resume the trial following submission of a protocol amendment to reduce the overall duration of the CATT1 trial from 12 months to 6 months, which will help to expedite the initiation of required larger pivotal studies for future New Drug Application (NDA) submission. The original primary endpoint of ascertaining level 2 and 3 hypoglycemia rates at 6 months will not change. The planned amendment will not include the additional 6-month period to collect safety data. By shortening the trial from 12 to 6 months, the Company will be able to obtain topline data from the study more quickly. “We are pleased that the FDA has lifted the clinical hold on our cadisegliatin program and are eager to resume our Phase 3 trial. Importantly, we plan to submit a protocol amendment to reduce the time to topline data by 6-months, which will allow us to initiate our larger Phase 3 studies sooner to support our future NDA submission,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “Cadisegliatin has the potential to be the first oral adjunctive therapy to insulin for T1D and we look forward to further evaluating the effects of cadisegliatin on glycemic control and incidence of hypoglycemia over insulin alone after reinitiating the CATT1 Phase 3 trial.” On July 26, 2024, vTv Therapeutics announced a clinical hold on the CATT1 Phase 3 trial based on the discovery of a chromatographic signal in a human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin that could not be resolved by standard mass spectroscopy. No patient had been dosed in the CATT1 trial at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues. The clinical hold was lifted as of March 14, 2025, following submission of a complete response letter by vTv Therapeutics which concluded that the chromatographic signal was an experimental artifact. Cadisegliatin (TTP399) is a novel, oral small molecule, liver selective glucokinase activator being investigated as a potential first-in-class oral adjunctive treatment to insulin for type 1 diabetes (T1D). In nonclinical studies, cadisegliatin, acting selectively on the liver, increased the activity of glucokinase independently from insulin, which supports clinical investigation of improvement in glycemic control through hepatic glucose uptake and glycogen storage. Cadisegliatin is under investigation and the safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated. vTv Therapeutics Inc. is a late stage biopharmaceutical company focused on developing novel oral, small molecule drug candidates intended to help treat millions with chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes. The content above comes from the network. if any infringemenlease contact us to modify.