ADX71441 in addiction

Indivior PLC - Our partner Indivior is developing ADX71441 for the treatment of addiction. Under our agreement with Indivior, Indivior is responsible for, including the financing of, development and commercialization, if any, of ADX71441. We have announced on October 3, 2017 that ADX71441 has received a grant from the US National Institute for Drug Abuse ("NIDA") of USD 5.3 million to fund Phase 1 and a Phase 1b cocaine interaction study. Consequently, we expect Indivior to initiate a Phase 1 clinical trial of ADX71441 in the second half of 2018. Addiction is an indication with significant commercial opportunity. Existing therapies often do not provide effective control of symptoms or have side effects that discourage adherence. We believe that ADX71441 may provide significant benefit to patients.

GABA is implicated in the central reward process, a neurophysiologic process that drives the uncontrolled, compulsive behaviours defining the addicted state. Both preclinical experiments and randomised clinical trials have demonstrated the efficacy of the GABA¬B receptor agonist baclofen in reducing alcohol withdrawal syndrome and voluntary alcohol intake.

ADX71441 has shown great efficacy in preclinical models of alcohol and cocaine use disorders and of nicotine withdrawal, in research studies supported by the National Institute on Drug Abuse (NIDA) and the National Institute of Alcohol Abuse and Alcoholism (NIAAA) (Hwa 2014, Augier 2017).

Given the complexity of clinical development in alcohol and cocaine abuse disorders, clinical trials in these indications will only be considered in collaboration with commercial partners or government organisations who will bring their own expertise and support.