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vTv Therapeutics Announces Initiation of Multiple Ascending Dose Study of HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis
Phase 1 multiple ascending dose study to evaluate safety of HPP737 in healthy volunteers and inform dose selection for phase 2 planned for 2H 2021 Strategic
About this update from Vtv Therapeutics Inc.
[{"type":"text","content":"Phase 1 multiple ascending dose study to evaluate safety of HPP737 in healthy volunteers and inform dose selection for phase 2 planned for 2H 2021 Strategic Partner in Asia and Pacific Rim, Newsoara Biopharma, has initiated a phase 2 study in COPD in China HIGH POINT, N.C., Feb. 17, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and inflammatory diseases, today announced the initiation of a phase 1 multiple ascending dose study evaluating an orally administered phosphodiesterase type 4 (“PDE4”) inhibitor, HPP737, to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of HPP737 in healthy adult volunteers. The Company expects to complete the study in Q2 2021. This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate up to 3 doses of HPP737 administered for 14 days in healthy volunteers. The goal of this study is to determine the maximum tolerated dose with minimal or no gastrointestinal intolerance to inform dose selection for a phase 2 study in psoriasis which is planned for later this year. HPP737 is a novel, potent, orally administered PDE4 inhibitor discovered by vTv Therapeutics. PDE4 has been demonstrated to be a validated therapeutic target for the treatment of a variety of disorders including psoriasis. In two prior phase 1 single- and multiple-ascending dose studies, HPP737 was well tolerated, with little or no gastrointestinal adverse events, such as nausea, vomiting or diarrhea, across the range of doses tested. HPP737 has evidence supporting target engagement from an ex vivo LPS stimulation TNF-alpha production assay and has demonstrated very potent activity in the Th17 skin resident immune cell activation (sRICA) assay, in which HPP737 was 10-100 fold more potent than apremilast in inhibiting the generation of cytokines/chemokines, depending upon the analyte. Additionally, the company’s strategic partner, Newsoara Biopharma, has advanced HPP737 into phase 2 with the initiation of a proof of concept study in chronic obstructive pulmonary disease (COPD) in China. The phase 2 study in COPD follows the completion of a phase 1 pharmacokinetic bridging study in which HPP737 was well tolerated with no dose limiting safety or tolera...