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vTv Therapeutics Inc. reports developments as a late-stage biopharmaceutical company focused on oral, small-molecule drug candidates for diabetes and other chronic diseases. Its clinical pipeline is led by cadisegliatin (TTP399), a liver-selective glucokinase activator being investigated as an oral adjunctive therapy to insulin for type 1 diabetes. Company updates also reference development work and partnerships across additional chronic-disease candidates, including the PDE4 inhibitor HPP737.
Recurring announcements include clinical and regulatory updates for cadisegliatin, financial results and corporate updates, license and collaboration activity, investor-conference participation, and Nasdaq inducement grants under equity compensation plans. News about vTv often connects pipeline progress with funding arrangements, intellectual property, and business-development agreements that support its drug-development strategy.
vTv Therapeutics Inc. (Nasdaq: VTVT) announced promising results from the JDRF-supported SimpliciT-1 Study published in Diabetes Care. The study evaluated the safety and efficacy of TTP399, a glucokinase activator, in adults with type 1 diabetes (T1D). Findings showed a statistically significant reduction in HbA1c and a clinically meaningful 40% decrease in severe hypoglycemic events compared to placebo. The results suggest TTP399's potential as a viable adjunctive therapy for T1D, with further studies planned for later this year.
vTv Therapeutics (Nasdaq: VTVT) announced the initiation of a Phase 1 multiple ascending dose study for the orally administered PDE4 inhibitor, HPP737. This study aims to assess safety and pharmacokinetics in healthy volunteers and will help determine the optimal dose for a planned Phase 2 study in psoriasis. The trial is expected to conclude by Q2 2021. Additionally, strategic partner Newsoara Biopharma has started a Phase 2 study in COPD in China, following favorable Phase 1 results. HPP737 shows promise as a well-tolerated treatment with strong efficacy in preliminary assays.
vTv Therapeutics, a clinical-stage biopharmaceutical company, announced participation in the LifeSci Partners 10th Annual Healthcare Corporate Access Event from January 11-14, 2021. The event will be held virtually, allowing company management to conduct one-on-one meetings concurrently with J.P. Morgan’s 39th Annual Healthcare Conference. vTv focuses on developing oral treatments for type 1 diabetes and inflammatory diseases, alongside pursuing additional indications in areas like type 2 diabetes and chronic obstructive pulmonary disease.
vTv Therapeutics (Nasdaq: VTVT) has announced that its Phase 2 Elevage study of azeliragon for mild Alzheimer’s disease and type 2 diabetes did not meet its primary objective of improving cognitive function as measured by ADAS-cog14. The trial involving 43 participants showed a 1.8-point decline in the azeliragon group compared to 0.35 in the placebo group, with the differences not being statistically significant. Despite this, azeliragon was well-tolerated. The company will continue analyzing the data for future applications.
Aditum Bio announces the formation of Anteris Bio, its third portfolio company, aimed at developing new therapies for renal disease following the successful in-licensing of ANT-401 from vTv Therapeutics (NASDAQ:VTVT). Chronic kidney disease, affecting nearly 700 million globally, has limited effective treatments. ANT-401 activates Nrf2, presenting potential for modifying renal disease progression. Aditum partners with TrialSpark to enhance clinical trial efficiency, offering faster recruitment through innovative methods.
vTv Therapeutics has signed a licensing agreement with Anteris Bio for its Nrf2 activator compound, HPP971, aimed at renal disease treatment. Anteris will pay vTv $2 million upfront and may provide up to $151 million in future milestones, along with royalties on sales. HPP971, which has completed two Phase 1 studies, will be renamed ANT-401 and may address chronic kidney disease (CKD), affecting 700 million globally. vTv continues to seek development opportunities for its other Nrf2 compounds.
vTv Therapeutics Inc. (Nasdaq: VTVT) has entered a $47 million common stock purchase agreement with Lincoln Park Capital Fund, LLC to support its clinical trials. This financing will facilitate key developments, including the upcoming results from the Elevage Study for Alzheimer’s and diabetes, and studies for TTP399 and HPP737 aimed at treating diabetes and psoriasis, respectively. The agreement allows vTv to sell shares over a 36-month period, and vTv retains the option to terminate it anytime without penalty.
vTv Therapeutics Inc. (Nasdaq:VTVT) reported its Q3 2020 financial results, revealing a net loss of $2.3 million, an improvement from $5.0 million in Q2. Cash reserves dropped to $1.8 million from $6.4 million. The company concluded enrollment in the Elevage Study of azeliragon for Alzheimer's, expecting topline results in December 2020. Plans for further studies of TTP399 are underway, including a mechanistic study and pivotal trials for type 1 diabetes. R&D expenses decreased to $1.8 million, while G&A expenses were $1.1 million, both showing cost management efforts.
vTv Therapeutics Inc. (Nasdaq: VTVT) announced baseline characteristics from the Elevage clinical study, which evaluates azeliragon for mild Alzheimer's disease in patients with type 2 diabetes. The study includes 43 enrolled patients, showing similar characteristics to a previous subgroup from the STEADFAST trial. Preliminary data suggest the potential efficacy of azeliragon, with the company expecting to report topline results in December 2020. The Elevage study aims to confirm prior findings in a 6-month Phase 2 trial before moving to Phase 3.
vTv Therapeutics Inc. (Nasdaq: VTVT) will present at the 13th Clinical Trials on Alzheimer’s Disease Digital Event on November 4, 2020. The presentation will showcase data from the phase 2 Elevage Study of azeliragon, aimed at treating mild-probable Alzheimer’s in patients with type 2 diabetes. Patient enrollment was completed in September 2020, with topline results expected in December 2020. Preliminary analysis reveals statistically significant cognitive improvements in a subgroup of patients treated with azeliragon compared to placebo, suggesting potential efficacy of the treatment.