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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 (Nasdaq: VTVT) reported Q1 2021 financials, highlighting key developments in its diabetes treatment program. The FDA granted Breakthrough Therapy designation to TTP399, which aims to significantly improve treatment for type 1 diabetes. The company initiated two phase 1 clinical studies for TTP399 and HPP737, with topline results expected in Q3 2021. Financially, vTv reported $1.0 million in revenue and a net loss of $4.2 million, translating to a diluted loss of $0.08 per share. Cash reserves increased to $8.4 million, showing better liquidity compared to the previous quarter.
vTv Therapeutics Inc. (Nasdaq: VTVT) announced that the FDA has granted Breakthrough Therapy designation for TTP399, an oral investigational therapy for type 1 diabetes. This designation allows for expedited development and review, acknowledging TTP399's potential to significantly improve clinical outcomes. Positive results from the phase 2 SimpliciT-1 study highlighted a significant reduction in HbA1c and hypoglycemia events. This milestone addresses a serious medical need for over a million individuals affected by type 1 diabetes.
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vTv Therapeutics announced the issuance of the U.S. Patent 10,952,993, protecting treatment methods using TTP399 for type 1 diabetes. This patent, expiring in 2039, covers lowering HbA1c and reducing hypoglycemia incidence by administering 400 mg to 1200 mg of TTP399 daily alongside insulin. The company aims for Orange Book listing and is enhancing its patent portfolio. TTP399 is currently under study for diabetic ketoacidosis and is set for pivotal trials this year.
vTv Therapeutics (Nasdaq: VTVT) announced the start of a mechanistic phase 1 study to evaluate TTP399, a liver-selective glucokinase activator, in people with type 1 diabetes. This study focuses on the effects of TTP399 on ketone formation during insulin withdrawal, aiming to demonstrate that it does not increase ketone production, a precursor to ketoacidosis. Previous phase 2 studies showed TTP399 improved glycemic control without raising the risk of ketoacidosis or hypoglycemia. The company plans to initiate a pivotal study later this year.
vTv Therapeutics Inc. (Nasdaq: VTVT) announced its participation in the H.C. Wainwright Global Life Sciences Conference, scheduled virtually for March 9-10, 2021. During the event, the company will offer a general update through an on-demand presentation starting March 9, and management will hold one-on-one virtual meetings with investors. vTv focuses on developing oral treatments for type 1 diabetes and inflammatory diseases, with a clinical pipeline that includes indications for other diseases such as type 2 diabetes and COPD.
vTv Therapeutics Inc. (Nasdaq: VTVT) reported its financial results for Q4 2020, showing a revenue of $6.4 million, driven primarily by a licensing agreement with Anteris Bio. The company transitioned from a net loss of $2.3 million in Q3 2020 to a net income of $1.6 million in Q4. The Phase 2 SimpliciT-1 study results for TTP399 were published, showing significant reductions in HbA1c for type 1 diabetes patients. The firm plans to initiate pivotal trials for TTP399 in H2 2021 and has a cash position of $5.7 million.
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.