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vTv Therapeutics Inc. (Nasdaq: VTVT) is a clinical-stage biopharmaceutical company committed to discovering and developing orally administered treatments for metabolic and inflammatory diseases. The company aims to address unmet medical needs through its innovative technology that modulates human proteins into effective medicines. vTv Therapeutics' diverse pipeline includes small molecule clinical and pre-clinical drug candidates targeting a range of conditions such as central nervous system disorders, diabetes, metabolic disorders, inflammation, and cancer.
Leading vTv Therapeutics' pipeline is cadisegliatin (TTP399), an investigational liver-selective glucokinase activator being developed as an adjunctive therapy to insulin for type 1 diabetes (T1D). Cadisegliatin is currently in preparation for Phase 3 clinical trials, with the first study expected to commence in mid-2024. In addition, vTv is exploring further indications for cadisegliatin in type 2 diabetes and other chronic conditions in collaboration with G42 Healthcare Research Technology Projects LLC and IROS, a UAE-based health technology group.
The company has achieved several milestones, including a strategic partnership with Reneo Pharmaceuticals for its PPARδ agonist program. This collaboration includes the potential for significant milestone payments and commercial royalties contingent on the success of Reneo's lead program, mavodelpar.
Apart from its focus on diabetes, vTv Therapeutics is also advancing other promising candidates. These include:
- TTP273: A treatment aimed at metabolic diseases.
- HPP737 and HPP593: Targeting inflammatory disorders.
- Azeliragon: Licensed to Cantex Pharmaceuticals for further development in treating glioblastoma and pancreatic cancer.
vTv Therapeutics continues to build strong financial support, backed by proceeds from strategic sales and investments. Recently, the company secured funds through a private investment in public equity (PIPE) deal to support the upcoming Phase 3 trial of cadisegliatin.
Overall, vTv Therapeutics Inc. is positioned at the forefront of innovative treatments, leveraging its small molecule drug candidates to potentially transform the management of chronic diseases and improve patient outcomes.
vTv Therapeutics announced positive results from a mechanistic study of TTP399, a treatment for type 1 diabetes (T1D), indicating it does not increase blood ketone levels during insulin withdrawal, minimizing the risk of ketoacidosis. Patients on TTP399 experienced improved fasting plasma glucose and fewer hypoglycemic events compared to placebo, with no incidents of hypoglycemia reported. The study, involving 23 participants, met its primary endpoint and sets the stage for a Phase 3 program expected to commence in early 2022.
vTv Therapeutics announced positive results from a multiple ascending dose study of HPP737, an orally administered PDE4 inhibitor, in healthy adults. The study showed a favorable safety profile without dose limiting gastrointestinal side effects. With a successful pre-IND meeting with the FDA, vTv plans to submit an IND application for a Phase 2 trial in moderate to severe psoriasis later this year, with the study set to begin in early 2022. These results suggest potential for HPP737 as a safer alternative for treating psoriasis.
vTv Therapeutics Inc. (Nasdaq:VTVT) reported its Q2 2021 financial results, highlighting a net loss of $608,000, significantly improved from a $4.2 million loss in Q1 2021. Cash reserves increased to $10.8 million. The company held a productive FDA meeting regarding its Breakthrough Therapy designation for TTP399, planning two pivotal studies to commence in early 2022. Revenue for Q2 was minimal at $9, with $2.4 million in R&D expenses. vTv announced a $50 million ATM equity program to support ongoing developments.
vTv Therapeutics, a clinical-stage biopharmaceutical company, announced it will present clinical data on HPP737, an orally administered PDE4 inhibitor for psoriasis, at the 6th World Psoriasis & Psoriatic Arthritis Conference from June 30 to July 3, 2021. The poster, titled Pharmacokinetics and Pharmacodynamics of HPP737, will be presented by Aaron Burstein, PharmD. HPP737 has shown strong efficacy and safety in clinical trials, making it a promising treatment option for psoriasis. More details will be available on vTv's website post-presentation.
vTv Therapeutics has announced a licensing agreement with Cantex Pharmaceuticals, granting Cantex exclusive rights to develop and commercialize azeliragon, a drug aimed at treating complications associated with cancer. This phase 2-ready medication has shown a favorable safety profile in previous Alzheimer’s trials. Cantex plans to initiate clinical trials to explore azeliragon's potential. The collaboration allows both companies to share profits from the commercialization of the drug, promising a strategic partnership in addressing significant medical needs.
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.
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.
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