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, NC, USA I February 17, 2021 I 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 tolerability findings and little or no gastrointestinal distress. Newsoara is also initiating phase 2 studies in psoriasis and atopic dermatitis, respectively, in 2021.
“The initiation of this study with HPP737 is an important next step for our company and we hope to demonstrate HPP737’s potential to be a well-tolerated, next-generation PDE4 inhibitor,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “We are also very pleased with Newsoara’s clinical advancements in China and plan to leverage the data generated in these studies to complement our development efforts in the rest of the world.”
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and inflammatory disorders, including psoriasis. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease, and primary mitochondrial myopathy. For more information, please visit https://vtvtherapeutics.com/ or follow us on Twitter: @vTvTherapeutics.
About Newsoara Biopharma
Newsoara is a biotech company based in Shanghai, China with research laboratories in the Suzhou BioBAY focusing on novel drug research and development to address unmet medical needs in patients with respiratory, metabolic, autoimmune and oncology diseases.
SOURCE: vTv Therapeutics
Post Views: 266
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, NC, USA I February 17, 2021 I 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 tolerability findings and little or no gastrointestinal distress. Newsoara is also initiating phase 2 studies in psoriasis and atopic dermatitis, respectively, in 2021.
“The initiation of this study with HPP737 is an important next step for our company and we hope to demonstrate HPP737’s potential to be a well-tolerated, next-generation PDE4 inhibitor,” said Steve Holcombe, chief executive officer, vTv Therapeutics. “We are also very pleased with Newsoara’s clinical advancements in China and plan to leverage the data generated in these studies to complement our development efforts in the rest of the world.”
About vTv Therapeutics
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and inflammatory disorders, including psoriasis. vTv’s development partners are pursuing additional indications in type 2 diabetes, chronic obstructive pulmonary disease (COPD), renal disease, and primary mitochondrial myopathy. For more information, please visit https://vtvtherapeutics.com/ or follow us on Twitter: @vTvTherapeutics.
About Newsoara Biopharma
Newsoara is a biotech company based in Shanghai, China with research laboratories in the Suzhou BioBAY focusing on novel drug research and development to address unmet medical needs in patients with respiratory, metabolic, autoimmune and oncology diseases.
SOURCE: vTv Therapeutics
Post Views: 266
