GlobeNewswire§GlobeNewswire•January 13, 2020
New chemical entity and selective muscarinic receptor antagonist targeting large unmet need for a new treatment that can meaningfully improve the lives of patients with neurological conditions
DALLAS and FORT WORTH, Texas, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today announced that it has initiated and completed dosing in a Phase 1 pilot pharmacokinetic study evaluating the safety and tolerability of NT0502 in healthy volunteers. NT0502 is a new chemical entity and selective anticholinergic agent that, based on preclinical data, is preferential for blocking muscarinic receptors in the salivary glands. The Company is developing NT0502 for the treatment of chronic sialorrhea, which is defined as prevalent and excessive drooling from the mouth resulting from the inability to control and swallow oral secretions, a common problem in patients with a variety of debilitating neurological conditions. Top-line pharmacokinetic data from the study is expected in the first quarter of 2020.
“There is significant market need for new treatments for chronic sialorrhea that can improve the quality of life for the millions of patients with neurological conditions, such as Parkinson’s disease, cerebral palsy and amyotrophic lateral sclerosis (ALS), who must also live with the associated burden of excessive drooling,” said Jerry McLaughlin, President and Chief Executive Officer. “NT0502 has a novel mechanism that offers the promise of an effective treatment with an improved tolerability profile for patients relative to existing pharmacologic options for chronic sialorrhea. We are looking forward to the results of this pilot pharmacokinetic study and the continued progress of NT0502 through the clinic.”
The Phase 1 trial for NT0502 is a single-dose open-label, randomized study to assess the systematic exposure and safety of four ion-resin, modified-release orally disintegrating tablet formulations of NT0502 and oxybutynin in 30 healthy adults. Data from this study will provide insights into the pharmacokinetic profile of the four formulations and provide guidance on final formulation selection and dosing for future clinical trials.