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
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 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.
Forward-Looking Statements
This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the timing of our clinical trials, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures or investments we may undertake. We qualify all of our forward-looking statements by these cautionary statements.
Contacts
Investors:
Corey Davis
LifeSci Advisors
CDavis@LifeSciAdvisors.com
or
Media:
Source: vTv Therapeutics Inc.
