Lyon, 2 May 2018 - Theranexus, a biopharmaceutical company innovating in the treatment of neurological diseases and pioneer in the development of drug candidates modulating the interaction between neurons and glial cells, , will be delivering an oral presentation on its progress toward "a potential novel approach to treat Excessive Daytime Sleepiness (EDS): Targeting neurons and glial cells with THN102", at the European Conference on Narcolepsy to be held on 5 and 6 May in Montpellier.
Organised by Professor Yves Dauvilliers, this conference brings together European specialists in narcolepsy. They will discuss current knowledge in the areas of clinical research, neurophysiology, biomarkers, cognition and new therapeutic prospects. In this context, Dr Werner Rein, Chief Medical Officer of Theranexus, will be presenting the potential of Theranexus' new approach to treating EDS in narcoleptic patients with the drug candidate THN102, which targets neurons and glial cells.
“I am delighted to present to the community of narcolepsy experts the innovative approach of our drug candidate THN102 and its proof of concept and application prospects in the area of excessive daytime sleepiness,” said Dr Werner Rein, Chief Medical Officer of Theranexus.
Theranexus has highlighted the key role of glial cells in the response to to Central Nervous System drugs (targeting only neurons), that are used in the treatment of certain neurological disorders. Research has shown, for the first time, that it is possible to increase the efficacy of these drugs by targeting glial cells. This increased efficacy allows for improved neuronal function and thus better management of the symptoms of neurological disorders. The patented drug candidate THN102, resulting from Theranexus' science thanks to its proprietary platform, is a combination of drugs, associating Modafinil (the reference treatment in narcolepsy) with Flecainide (a repositioned drug targeting glial cells). The THN102 candidate is expected to be significantly more effective than the reference treatment.
Speaker: Dr Werner Rein, Chief Medical Officer, Theranexus
Title: Targeting neurons and glia with THN102: a potential novel approach to treat excessive daytime sleepiness
Date and time: Saturday, 5 May at 5.45 pm
Location: Former Medical School in Montpellier
THN102 (modafinil/flecainide combination) for the treatment of wakefulness impairment in narcolepsy and Parkinson's disease is the most advanced drug candidate developed by Theranexus. Having demonstrated its superior performance compared with the standard treatment in healthy volunteers, it is currently in phase II in narcolepsy, an orphan disease affecting approximately 300,000 patients in Europe and the United States and representing a market valued at $2 billion. At the same time, THN102 will begin another phase II clinical trial on excessive daytime sleepiness in Parkinson's disease, the second-most common neurodegenerative disease. Excessive daytime sleepiness is a debilitating symptom, closely associated with impairment of attention and cognition in the disease. There is currently no authorised treatment for the management of this symptom, which affects 30% of patients with Parkinson's disease. These two phase II trials represent an opportunity for strong value creation by 2019 to be materialised through an industrial partnership.
ABOUT THE STUDY IN NARCOLEPSY
This study entitled “Tolerance and efficacy of THN102 on sleepiness in narcoleptic patients” (NCT02821715) aims to demonstrate the superiority of THN102 over the reference treatment (modafinil) in narcoleptic patients with excessive residual daytime sleepiness despite treatment. It involves a minimum of 42 patients, is double-blind (neither the patient nor the doctor know which treatment is being assessed) and compares three treatments (modafinil 300 mg/day alone or in combination with two doses of flecainide, 3 and 27 mg/day) in cross-over over three periods: each patient receives each of the three treatments at random during three two-week periods. This study is coordinated by Professor Yves Dauvilliers, principal Investigator of the study, at the Montpellier University Hospital and is being conducted in parallel in five centres in France (Lille, Paris,
Bordeaux, Garches and Montpellier). The main outcome of the phase II study is measured by the Epworth Sleepiness Scale (ESS), and the study will be successful if the THN102 drug candidate, with one or two doses, scores significantly lower than modafinil alone on this scale. Narcolepsy is a rare disorder with an estimated global prevalence of 56 cases per 100,000 in the United States and 47 cases per 100,000 in the European Union.
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