C4x Discry Hdgs Regulatory News (C4XD)

C4X Discovery Holdings plc

("C4XD", "C4X Discovery" or the "Company")

Altasciences appointed by Indivior to conduct Phase I clinical trial with

C4XD's Orexin-1 for treatment of Opioid Use Disorder

9 December 2019 - C4X Discovery Holdings plc (AIM: C4XD), a pioneering Drug Discovery company, is pleased to note the announcement that 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 (C4X3256) Under Fasting and Fed Conditions in Healthy Volunteers".

Dr Clive Dix, Chief Executive Officer of C4XD, said: "We are delighted that Altasciences has been appointed by Indivior to manage the clinical development of our molecule C4X3256, a non-opioid, highly-selective Orexin-1 Receptor Antagonist for the treatment of Opioid Use Disorder. With initiation of the Phase I clinical trial in sight, and Altasciences and Indivior's expertise in the opioid field, we believe that our molecule has the potential to bring a new alternative treatment for patients suffering in what is a growing epidemic of opioid addiction. We follow the progress of our molecule in these trials with great anticipation."

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Below is the full announcement made today by Altasciences:

ALTASCIENCES TO CONDUCT CLINICAL TRIAL FOR OPIOID USE DISORDER UNDER NIH FUNDING

Laval, Quebec, December 9, 2019 - 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.

About AltasciencesAltasciences 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.

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Contacts

Notes to Editors:

About C4X Discovery

C4X Discovery (C4XD) aims to create the world's most productive Drug Discovery engine by using cutting-edge technologies and expertise to efficiently deliver best-in-class small-molecule medicines to clinical partners for the benefit of patients. The Company's business model focuses on replenishing big pharma discovery pipelines and driving returns through revenue generating pre-clinical licensing deals. In 2018, C4XD successfully out-licensed a pre-clinical programme in addictive disorders to Indivior in a deal worth up to $294m.

C4XD has a state-of-the-art suite of proprietary technologies across the Drug Discovery process and accesses further innovative capabilities and expertise through its growing network of partners. The Company is actively advancing its diverse pre-clinical discovery portfolio which is focused on inflammation, neurodegeneration and oncology (including immuno-oncology). Opportunities to maximise value from the portfolio are proactively driven by C4XD's commercial division. The Company is led by a highly experienced management team and Board who have delivered significant value creation within the healthcare sector.

For additional information please go to: www.c4xdiscovery.com