French-based, clinical-stage biopharmaceutical company Theranexus has reported positive results from its proof of concept clinical trial of THN102, to treat excessive daytime sleepiness (EDS) induced by sleep deprivation in healthy volunteers.
EDS is a symptom affecting a number of patients with CNS disorders, such as narcolepsy or Parkinson’s disease.
The study results demonstrate a beneficial effect of THN102, a combination of modafinil and flecainide repurposed at low dose as glial connexin modulator, on outcomes measuring vigilance and cognition throughout the sleep deprivation and when compared to the standard of care modafinil.
The double-blind, randomised, placebo and active comparator (modafinil) controlled, incomplete cross-over study is led by Dr Fabien Sauvet from French Armed Medical Research Institute (IRBA) at Percy military hospital, Clamart, France.
The study was funded by French Defence Procurement and Technology Agency (DGA) under the RAPID programme, and conducted on 20 healthy volunteers undergoing sleep deprivation.
Theranexus noted that THN102-treated volunteers showed a statistically significant improvement in their vigilance levels, which was the primary endpoint of the study, compared to modafinil alone.
Secondary endpoints evaluating cognition were consistent with this effect.
Theranexus CSO Dr Mathieu Charvériat said: "Reaching the primary endpoint of efficacy versus modafinil on the levels of vigilance provides further evidence of the synergistic effects of modafinil with flecainide low dose.
"Results from the secondary endpoints were also very promising. The THN102 treated group experienced fewer adverse events compared with the modafinil treated group as well.
"This is really exciting as we see a strong evidence for the translation in man of Theranexus’ concept of associating a glial modulator with a CNS drug to increase the efficacy of the latter."
Recently, the company had started a Phase ll trial of THN102 in narcolepsy, with results expected by the second half of next year.