Lyon, 13 February 2019 – 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, today announces its year-end cash position and presents an update on the current status of its activities.
Total available funds on 31 December 2018 stood at €15.2M, compared with €15.8M on 30 September 2018, reflecting effective cost control. These figures take into account the €720k Research Tax Credit paid out in Q4 2018.
"This past year marked the launch of new studies serving to bolster and round out our portfolio of clinical drug candidates. Alongside these achievements, Theranexus has succeeded in keeping firm control of its cash consumption. The 2019 financial year promises to be full of exciting clinical breakthroughs, with Phase II results in narcolepsy treatment expected very soon, followed by Phase II results in Parkinson's disease patients and Phase I proof of concept results for neurocognitive disorders. In addition to plentiful news regarding clinical testing, the coming year will see the deployment of Neurolead, our new high value-added active agent screening platform, designed to address unmet medical needs," said Franck Mouthon, Chairman and CEO of Theranexus.
UPDATE ON STATUS OF ACTIVITIES
THN102 - Narcolepsy and Parkinson's Disease
THN102 (modafinil/flecainide combination) is currently undergoing Phase II clinical trials in two indications aimed at treating wakefulness disorders in narcolepsy patients and excessive daytime sleepiness in Parkinson's disease patients. For Parkinson's disease, the trial's primary endpoint is tolerance to the treatment of the drug candidate THN102, with secondary efficacy endpoints including an assessment of drowsiness, alertness and cognition. The trial, enrolling 60 individuals, has already recruited more than a third of its patients, with all 20 planned sites open across Europe and the United States. The results of the trial are scheduled for release by the end of the first half of 2019. Results from THN 102 Phase II trials on narcolepsy patients are expected in the next few weeks.
THN201 - Alzheimer's Disease
THN201 is a drug candidate for the treatment of neurocognitive disorders associated with Alzheimer's disease and moved into phase Ib trials in September 2018. It contains a combination of donepezil, which acts on neuronal activity, and mefloquine, affecting glial cell activity. Recruitment for the trial, which is expected to include 150 healthy volunteers spread over 8 sites in France, is ongoing. Results will be made available by the close of 2019.
THN101 - Neuropathic pain
The THN101 phase Ia safety, tolerability and pharmacokinetics trial in patients with neuropathic pain is in progress. The Phase II program is scheduled to get underway this year and will include 370 patients suffering from neuropathic pain of diabetic or post-zosterian origin (following shingles) in 40 to 45 investigation sites in Europe. The trial's main criterion will be based on a regular self-assessment of pain by the patients themselves using a numerical scale.
Neurolead, a new platform enabling active agent screening of neuron-glia interactions
Theranexus was awarded a €6.2 million funding package under Bpifrance's Investments for the Future scheme, for the Neurolead program. This program, coordinated by Theranexus in collaboration with the Collège de France and the French Alternative Energies and Atomic Energy Commission, aims to design and industrialize a unique platform for the identification and characterization of drug candidates targeting neurological disorders.
Neurolead, using the latest innovations in neuroscience and AI tools, plans to extend and systematize the therapeutic concept pursued by Theranexus by enhancing its therapeutic application capabilities.
Next financial publication:
Monday, April 29, 2019 (before market opening): 2018 annual financial results
Financial and Administrative Director
ACTUS finance & communication
Caroline Lesage / Théo Martin
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