LAVAL, Quebec – (BUSINESS WIRE) – Altasciences is door Indivior PLC geselecteerd om “A Phase I, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X_3256) Under Fasting and Fed Conditions in Healthy Volunteers“, conform de National Institutes of Health (NIH) Funding Opportunity Announcement RFA-DA-19-002, gewijd aan de ontwikkeling van medicijnen om opioïdengebruikstoornis en overdosis te voorkomen en te behandelen. De subsidie werd door de NIH aan Indivior verleend in het fiscale jaar 2019 om wetenschappelijke oplossingen toe te passen om de nationale opioïdecrisis te keren. In maart 2018 is Indivior een licentieovereenkomst aangegaan met C4X Discovery Holdings PLC (C4X) waarbij Indivior exclusieve wereldwijde rechten heeft verkregen om INDV-2000 te ontwikkelen en te commercialiseren (C4X_3256).
Altasciences to Conduct Clinical Trial for Opioid Use Disorder Under NIH Funding
LAVAL, Quebec–(BUSINESS WIRE)– Altasciences has been selected by Indivior PLC to conduct “A Phase I, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X_3256) Under Fasting and Fed Conditions in Healthy Volunteers“, pursuant to the National Institutes of Health (NIH) Funding Opportunity Announcement RFA-DA-19-002, dedicated to the development of medications to prevent and treat opioid use disorder and overdose. The grant was made to Indivior by the NIH in fiscal year 2019, to apply scientific solutions to reverse the national opioid crisis. In March 2018, Indivior entered into a license agreement with C4X Discovery Holdings PLC (C4X) whereby Indivior obtained exclusive global rights to develop and commercialize INDV-2000 (C4X_3256).
The first-in-human, single-ascending-dose study will be conducted in two parts — Part I: double-blind, placebo-controlled, randomized, single-ascending-dose study in fasted condition. Part II: open-label, cross-over randomized, food interaction, single-dose study, which will be given once under fasting conditions and once at completion of a standard FDA high-fat breakfast.
Altasciences offers extensive knowledge and expertise in the conduct of opioid use disorder trials and has numerous years of conducting NIH- and FDA-funded clinical studies, prior to undertaking this most recent research.
“We look forward to partnering with Indivior and are proud to continue our long-standing contributions to advancements in the treatment of opioid use disorder. Since our first NIH grant award in 2012, we have consistently contributed to the body of knowledge in the field, and have helped accelerate development of these vital options for treating opioid addiction,” says Chris Perkin, Chief Executive Officer of Altasciences.
Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, and data management, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster.