Theranexus announces today that it has recruited the last patient in its Phase II trial, entitled “Tolerance and Efficacy of THN102 on Sleepiness in Narcoleptic Patients”.
Lyon, 29 October 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, announces today that it has recruited the last patient in its Phase II trial, entitled “Tolerance and Efficacy of THN102 on Sleepiness in Narcoleptic Patients”. A total of 48 patients were recruited across seven centers in France and Belgium under the coordination of Professor Yves Dauvilliers, the trial’s Principal Investigator, based at the Montpellier Regional University Hospital’s National Reference Center for Narcolepsy.
” Above all, we would like to thank the patients and physicians who placed their trust in us to make this trial a success. We are pleased to achieve this key milestone in our Phase II clinical trial on narcolepsy-related wakefulness disorders. In view of the high expectations of narcolepsy patients who continue to suffer acutely from disease symptoms despite being administered the latest available treatments, we are eager to share the results of this trial, which aims to demonstrate the superiority of our drug candidate THN102 compared to the standard of care drug,” stated Franck Mouthon, President and CEO of Theranexus.
ABOUT THE PHASE II TRIAL OF THN102 IN NARCOLEPSY PATIENTS
Narcolepsy is a rare neurological disease characterized by excessive and uncontrollable daytime sleepiness frequently associated with cataplexy episodes [1]. Narcolepsy affects approximately 300 000 patients in Europe and the United States and represents a market valued at $2 billion.
The trial, entitled “Tolerance and Efficacy of THN102 on Sleepiness in Narcolepsy Patients” (NCT02821715) aims to demonstrate the superiority of THN102 compared to the standard of care drug (modafinil) in narcolepsy patients who experience excessive residual daytime sleepiness despite treatment. Enrolling 48 patients, of whom a minimum of 42 patients have completed, the trial is double-blind (neither the patient nor the physician knows which treatment is being assessed), comparing three treatments (modafinil 300 mg/day alone or combined with two doses of flecainide, 3 and 27 mg/day) in three cross-over periods: patients receive, at random and for three two-week periods, each of the three treatments. The trial is coordinated by Professor Yves Dauvilliers, its Principal Investigator at Montpellier Regional University Hospital, and is being conducted in a parallel group design in seven centers in France (Lille, Paris, Bordeaux, Grenoble, Dijon and Montpellier) and Belgium (Erpent). The primary endpoint of the Phase II trial is measured using the Epworth Sleepiness Scale (ESS). The trial will be considered successful if the THN102 drug candidate, at one or two doses, scores significantly lower than modafinil alone on this scale.
THN102 (modafinil/flecainide combination) is Theranexus’ most advanced drug candidate in treating wakefulness disorders related to narcolepsy and Parkinson’s disease. After being shown to act more effectively than the standard of care drug in a sleep deprivation model using healthy volunteers whilst Phase II was being finalized in narcolepsy patients, THN102 also reached Phase II in excessive daytime sleepiness in Parkinson’s disease, the second most common neurodegenerative disease. Clinical results from both THN102 Phase II trials represent an opportunity to achieve two high value-creating milestones for Theranexus by 2019.
