Altasciences Performs Phase I Studies for FDA Approval of Vibegron
Laval, Quebec, February 23, 2021 – Altasciences is pleased to have contributed to the recent FDA approval of Vibegron, by performing multiple early phase clinical trials. Vibegron is a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. The approval was announced by Urovant Sciences on December 23, 2020.
“We take tremendous pride in contributing to the FDA approval of much-needed medicines that improve the health and wellbeing of patients,” said Amy Denvir, General Manager at Altasciences’ Kansas clinical pharmacology unit. “Working with Urovant Sciences on this program has been a pleasure, and we are delighted to see it come to fruition.”
Altasciences’ expert clinical teams provided clinical support for two drug-drug interaction studies and a bioavailability trial, conducted in 2018 and 2019, in healthy subjects. These trials were supported by Altasciences’ data services team, who performed the full data management and reporting for the associated clinical studies.
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.