Theranexus has enrolled the first patient for its Phase II clinical study of THN102 to treat excessive daytime sleepiness associated with narcolepsy in adult patients.
The Phase II study is being conducted as a double-blind, randomised, placebo-controlled trial, which will compare the safety and efficacy of two different doses of THN102 with an active comparator, modafinil, considered as the standard care to treat sleepiness in 48 narcolepsy patients.
The patients will be enrolled at three French centres known as the Montpellier Regional University Hospital, the Paris public hospital organisation APHP and Lille Regional University Hospital.
The study is mainly focused on achieving a decrease in sleepiness, which will be measured by the Epworth Sleepiness Scale (ESS).
Montpellier Regional University Hospital professor Yves Dauvilliers said: “This new approach developed by Theranexus carries with it a real sense of hope for a better answer to the ever-weighty medical needs in narcolepsy.
“If we confirm in patients the data obtained in disease models, as well as in healthy, sleep-deprived volunteers, then THN102 will represent an interesting therapeutic option for treating our patients once it is on the market.”
Narcolepsy, also termed as Gelineau’s disease or Gelineau’s syndrome, is a rarely occurring neurological disease that causes excessive, uncontrollable daytime sleepiness frequently associated with cataplexy, sleep paralysis, hypnagogic hallucinations, and altered night's sleep.
THN102 is an advanced drug candidate in the Theranexus portfolio and is the first to represent a new class of innovative therapeutic combinations that associate a neural activity modulator, in this case modafinil (Modiodal, Provigil), with a glial connexin modulator, which in the case of THN102 is low-dose flecainide.