RE: phase I trial update20 Aug 2020 10:44
The last update was from 30th July in INDV half year results - 1st dose in man planned for this month
NDV-1000 (Selective Orexin 1 [OX1]receptor antagonist):-On September 26, 2019 the National Institutes of Health (NIH) granted Indivior’s application entitled“Clinical Evaluation of C4X3256, a Non-Opioid, Highly-Selective Orexin-1 Receptor Antagonist for the Treatment of Opioid Use Disorder” pursuant to Funding Opportunity Announcement RFA-DA-19-002 dedicated to the development of medications to prevent and treat opioid use disorder and overdose.
Page | 2-Our development plans were presented at the first HEAL Investigator Meetingin Bethesda on January 16-17, 2020(see publication list).-The Single Ascending Dose (SAD) study was planned to start in April 2020 but wasdelayed by approximately 3 months due to the COVID-19 pandemic.The first dosing in Man is currently scheduled for August 2020.-Nonclinical pivotal toxicokinetics and embryofetal studies have been completed.