C4x Discry Hdgs Regulatory News (C4XD)

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-clinicaldevelopment 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 self-administration 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.

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For further information, please contact:

C4X Discovery Holdings plc

Clive Dix, Chief Executive Officer +44 (0)7801 865 803 

Panmure Gordon (UK) Limited (NOMAD and Broker) +44 (0)20 7886 2500

Freddy Crossley, Emma Earl (Corporate Finance)

Consilium Strategic Communications

Mary-Jane Elliott, Chris Gardner, Matthew Neal +44 (0)203 709 5700

About C4X Discovery

C4X Discovery aims to become the world's most productive drug discovery engine by exploiting cutting edge technologies to design and create best-in-class small-molecule candidates targeting a range of high value therapeutic areas. The company's goal is to drive returns through early-stage revenue-generating deals with the pharmaceutical industry.

C4X Discovery has a state-of-the-art suite of proprietary technologies across the drug discovery process. The company's innovative DNA-based target identification platform (Taxonomy3®) utilises human genetic datasets to identify novel patient-specific targets leading to greater discovery productivity and increased probability of clinical success. This is complemented by C4XD's novel drug design platform which comprises two innovative chemistry technologies, Conformetrix and Molplex, that combine 4D molecular shape analyses (based on experimental data) with best-in-class computational chemistry. This provides new and unprecedented insight into the behaviour of drug molecules, enabling the production of potent selective compounds faster and more cost effectively than the industry standard.

C4X Discovery is advancing its in-house pipeline in inflammation, neurodegeneration, immuno-oncology, addiction, and diabetes with a number of new drug candidates identified and further progress made towards the pre-clinical licensing discussions. In selecting new targets C4X Discovery focuses on high-value disease areas and maximise value from areas such as: immuno-oncology, addiction, and diabetes. The Company recently signed a licensing agreement with Indivior for addiction programme worth up to $294m.

The Company was founded as a spin-out from the University of Manchester. It has a highly experienced management team and Board who have delivered significant value creation within the healthcare sector historically and have enabled C4XD to reach multiple value inflexion points since IPO. For additional information please go to: www.c4xdiscovery.com

About Indivior

Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment. The name is the fusion of the words individual and endeavour, and the tagline "Focus on you" makes the Company's commitment clear. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 1,000 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more.