donepezil/mefloquine (THN 201) / Theranexus - LARVOL DELTA

[VIRTUAL] EFFECTS OF THN201, A COMBINATION OF DONEPEZIL AND LOW DOSE MEFLOQUINE, ON COGNITION AND QUANTITATIVE EEG IN HEALTHY SUBJECTS DURING A SCOPOLAMINE CHALLENGE (CTAD 2020) - "The results with THN201 demonstrate an augmentation of the fluidity of executive and memory processes as shown by the improvement of speed of memory in the CDR battery, as well as an increase of the power of the gamma band of the EEG compared to DZP alone suggesting an improvement in frontal lobe-related cognitive performance. These results corroborate the findings in animal models of cognitive impairments of the augmentation of the cognitive effects of donepezil with low-dose mefloquine."

Clinical • Alzheimer's Disease • Cognitive Disorders • Xerostomia

Pharmaco-fUS for Characterizing Drugs for Alzheimer's Disease - The Case of THN201, a Drug Combination of Donepezil Plus Mefloquine. (PubMed, Front Neurosci) - "As an example, we showed that although administration of donepezil or mefloquine alone at low dose had only very limited effects on the signal compared to the baseline, their combination produced marked hemodynamic effects in the hippocampus, in line with previously published behavioral data demonstrating a synergic interaction between both drugs. Thus, the present study provides new perspectives, (i) through the use of pharmaco-fUS, a new non-clinical imaging modality, to move forward drug discovery in AD and (ii) by the profiling of two drug treatments on brain dynamics, one used in AD: donepezil, and the other in development: donepezil combined with mefloquine (THN201) as a modulator of astrocyte network."

Clinical • Journal • Alzheimer's Disease • CNS Disorders

Efficacy of THN201, a Combination of Donepezil and Mefloquine, to Reverse Neurocognitive Deficits in Alzheimer's Disease. (PubMed, Front Neurosci) - "In parallel, we determined that MEF potentiated DPZ-induced release of acetylcholine in hippocampus. Finally, local genetic silencing of astrocyte Cxs in the hippocampus was also found to enhance the procognitive effect of DPZ, pointing out the importance of Cx-dependent astrocyte networks in memory processes."

Clinical • Journal • Alzheimer's Disease • CNS Disorders

Theranexus :- 2019 annual results and update on the progress of activities (Market Screener) - "Drug Candidate THN201 - Cognitive disorders in patients with Alzheimer's disease:...The company conducted a Phase Ib clinical trial on 150 healthy volunteers and announced the results in January 2020. The trial revealed an extension of the pharmacological profile of THN201 compared to donepezil, the standard-of-care treatment for this indication. The good pharmacological profile of THN201 has led Theranexus to seek an industrial partner to continue its development."

Licensing / partnership • P1 data

A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers (clinicaltrials.gov) - P1; N=152; Completed; Sponsor: Theranexus; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers (clinicaltrials.gov) - P1; N=152; Active, not recruiting; Sponsor: Theranexus; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Theranexus announces inclusion of last subject in its phase Ib trial of THN201 (Lyonbiopole) - "Theranexus...has announced the inclusion of the last healthy subject in its Phase Ib trial comparing the pharmacological efficacy of its drug candidate THN201 with the standard-of-care treatment in Alzheimer's disease-related neurocognitive disorders."

Enrollment status

A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers (clinicaltrials.gov) - P1; N=140; Recruiting; Sponsor: Theranexus; Trial completion date: Jul 2019 ➔ Dec 2019; Trial primary completion date: Jun 2019 ➔ Oct 2019

Clinical • Trial completion date • Trial primary completion date