C4X3256 programme awarded $480k NIDA grant

C4X Discovery Holdings plc

(“C4XD”, “C4X Discovery” or the “Company”)

C4X Discovery's C4X3256 programme awarded $480k grant from the US National Institute on Drug Abuse (NIDA)

Grant awarded to investigate efficacy of C4X3256 in preclinical models of cocaine addiction, further demonstrating the efficacy of C4X3256 across broad addiction indications

24 July 2018 – C4X Discovery Holdings plc (AIM:C4XD), a pioneering drug discovery company, is pleased to announce that C4X Discovery’s C4X3256 programme has been awarded a grant from the National Institute on Drug Abuse (NIDA, a division of National Institute of Health (NIH)). The grant of approximately $480k will support the pre-clinical development of C4X3256 in cocaine use disorder, an additional addiction indication with high unmet need. Recently licensed to Indivior, C4X3256, an oral Orexin-1 receptor antagonist, has demonstrated an excellent safety profile and preclinical efficacy in models of nicotine addiction.

An estimated 1.5 million adults are suffering from cocaine use disorder in the US alone. Current therapy relies on behavioural approaches, while most medications used in in-patient addiction treatment rehabilitation centers are indicated for other conditions and are associated with poor tolerability. Orexin-1 receptor antagonists present a new mechanism for the potential treatment of craving and/or prevention of relapse in cocaine addiction.

Supported by the grant from NIDA, C4X Discovery will investigate the efficacy of C4X3256 in preclinical selfadministration and reinstatement models of cocaine seeking and taking behaviours seen as analogous to those seen in cocaine use disorder. The preclinical studies will be co-ordinated by C4X Discovery via its drug discovery CRO network, with the support of its development partner, Indivior. The one-year project is expected to begin in Q3 2018. 

Craig Fox, Chief Scientific Officer of C4X Discovery, commented: “The team at C4X is delighted that the C4X3256 programme has received this grant award from NIDA, one of the US National Institutes of Health, in recognition of our drug discovery expertise and the current significant unmet medical need in  substance abuse disorders. Inhibition of the Orexin-1 receptor holds much promise as a novel clinical approach to prevent craving and relapse in multiple addictive diseases including cocaine use disorder. We have already demonstrated significant pre-clinical efficacy of our novel oral candidate C4X3256 in models of nicotine addiction and we look forward to the effectiveness in models of cocaine addiction being investigated.”

Christian Heidbreder, Chief Scientific Officer of Indivior, commented: “We express our sincerest gratitude to NIDA for supporting C4X3256 with our development partner C4X Discovery. A wealth of scientific evidence supports the involvement of the orexin system in compulsive and goal-oriented behaviours. As such, the use of selective Orexin-1 receptor antagonists holds promise as a new, innovative approach for the pharmacotherapeutic management of substance use disorders.”

This research is supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health under Award Number R01DA043898. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.