Theranexus Reaches Its Primary Endpoint in the Proof of Concept Trial of THN102 in Excessive Daytime Sleepiness (EDS)

LYON, France–(BUSINESS WIRE)–Theranexus, a clinical-stage biopharmaceutical company, announced today
top-line results from its proof of concept clinical trial in Excessive
Daytime Sleepiness (EDS) induced by sleep deprivation in healthy
volunteers. Those results show a beneficial effect of THN102
(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 study was a double-blind, randomised, placebo and active comparator
(modafinil) controlled, incomplete cross-over study in 20 healthy
volunteers undergoing sleep deprivation. This study was led by Dr.
Fabien Sauvet, from the French Armed Medical Research Institute (IRBA)
at the Percy military hospital, Clamart – France. Treatment units were
produced and released by the Central Pharmacy of Military Health
Service. The study was funded by the French Defense Procurement and
Technology Agency (DGA) under the RAPID program which aims at funding
innovations having both civil and military possible applications.
THN102-treated volunteers showed a statistically significant improvement
in their vigilance levels – the primary endpoint of the study – vs
modafinil alone. Secondary endpoints assessing cognition were consistent
with this effect. Detailed results will be published and presented at
upcoming conferences, and they reinforce the interest of THN102 for the
treatment of Excessive Daytime Sleepiness, a debilitating symptom
affecting a number of patients with CNS disorders such as narcolepsy or
Parkinson’s disease.
“Reaching the primary endpoint of efficacy vs. modafinil on the
levels of vigilance provides further evidence of the synergistic effects
of modafinil with flecainide low dose,” said Dr. Mathieu Charvériat,
CSO of Theranexus. “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.”
“We are grateful to the staff from the IRBA for the excellent job
they have done in this study which would not have been possible without
the support of the French Ministry of Defense,” stated Franck
Mouthon, CEO of Theranexus. “The efficacy of THN102 in this proof of
concept trial is highly encouraging for the patients suffering from
Excessive Daytime Sleepiness. This reinforces our confidence into the
recently started phase 2 trial in narcolepsy which outcome should be
known in the second half of 2017.“
This first evidence of efficacy with THN102 supports the translation
of Theranexus’ concept in man
Such evidence illustrates as well the ability of Theranexus’ science to
successfully move from the bench, with the results recently published in
the peer-reviewed journal Sleep, to the bedside.
Franck Mouthon added: “These results are a first validation in man of
Theranexus’ technology, based on the key role of glial connexins to
improve the safety and efficacy of CNS drugs. Beyond the THN102 project,
we see there a validation of our strategy that relies on the use of
marketed drugs and allowed us to reach this key milestone within 3 years
from the inception of the company.”
About Excessive Daytime Sleepiness (EDS)
Excessive daytime sleepiness (EDS) is characterized the inability to
stay alert and awake during the major waking episodes of the day,
resulting in unintended lapses into sleep. EDS can be considered as a
debilitating broad condition encompassing several sleep disorders where
increased sleep is a symptom, or as a symptom of another underlying
disorder like narcolepsy, Parkinson’s disease or Obstructive Sleep Apnea
(OSA).
About Theranexus
Founded in 2013, Theranexus is a biopharmaceutical company formed from a
spin-off of CEA – an institution recently recognized as the most
innovative research body in the world (as per ranking in Reuters’ Top 25
Global Innovators). Theranexus discovers and develops combinations
between CNS drugs and marketed drugs repurposed as glial connexin
modulators, with the objective of improving the effectiveness and
tolerance of established neurological and psychiatric treatments.
The Theranexus science offers a unique opportunity: accelerated clinical
development with a lower risk of project failure in high potential CNS
indications where authorized and established treatments have problems
either with tolerance and effectiveness, or with life-cycle management
in relation to patent expiries. Theranexus is VC-backed (Auriga
Partners, Emergence Innovations (Sofimac Partners), CEA Investissement
and Rhône-Alpes Création).
www.theranexus.com
About Military Health Service (Service de Santé des Armées)
The French Armed Medical Research Institute (IRBA), the Percy military
hospital, and the Central Pharmacy are entities of the Military Health
Service. This Institution is turned towards dual developments, based on
the collaborations between civil teams and Armed forces through high
level scientific and technological platforms and experimental models.
www.defense.gouv.fr