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  THERANEXUS company press release from 26/03/2019

  26/03/2019 - 07:30


New scientific research highlights glial cells' importance in modulating the therapeutic efficacy of psychotropic drugs

Lyon, 26 March 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, will present its latest findings on the role of astroglial connexins in the efficacy of THN201 in neurocognitive disorders linked to Alzheimer's disease[1] at the 2019 AD/PD conference in Lisbon, Portugal on 26-31 March 2019.

THN201 is a drug candidate designed to treat cognitive disorders in patients with Alzheimer's disease. It contains a combination of donepezil, which acts on neuronal activity, and mefloquine, affecting glial cell activity. THN201 has already demonstrated a preclinical efficacy profile superior to the standard of care drug as well as an excellent tolerance profile. The drug candidate is currently undergoing clinical investigation for efficacy in a Phase Ib trial.

The results obtained from these studies, conducted using state-of-the-art neuroscience technologies, have for the first time shown how glial cells can be used to enhance the procognitive activity of donepezil with mefloquine in preclinical dementia models.

“Improving how we manage cognitive disorders, especially in people with Alzheimer's disease, remains a major public health issue. Theranexus research has once again illustrated the key role of glial cells in modulating the therapeutic efficacy of psychotropic drugs. The Phase Ib trial launched in September 2018 will enable us to compile the first efficacy data for THN201 in humans, for comparison with the first-line treatment. The results of this study will be made available by the end of 2019," stated Franck Mouthon, Chairman and CEO of Theranexus.

About THN201 in cognitive disorders in Alzheimer's disease

Alzheimer's disease (AD) causes the slow degeneration of neurons which is characterised by short-term memory loss, impairment of some bodily functions and can cause spatial disorientation. Patients gradually lose their cognitive abilities and independence. Such neurocognitive disorders are particularly challenging, not only for patients but also for caregivers and families.

Today, many diseases characterised by neurocognitive disorders remain an economic burden and the cause of significant unmet medical needs. Health costs associated with neurocognitive disorders estimated at more than $640 billion worldwide, predominantly driven by institutionalization, continue to increase dramatically. Today, it is estimated that more than 45 million people worldwide have neurocognitive disorders. A number expected to reach nearly 75 million by 2030.

The associated multicentre study is being conducted in 8 French research centres. It involves 150 healthy volunteers. Patients are randomly selected and receive one of the treatments (or its placebo comparator) and are treated for 15 days. On day 1, participants receive a 50 mg oral dose of mefloquine (THN201 arm) or a corresponding placebo (in the placebo and donepezil arms). THN201 repeated-dose treatments - mefloquine (10 mg) and donepezil (5 mg) or donepezil (5 mg) and placebo mefloquine, or placebo donepezil and placebo mefloquine – are given orally once daily from D-1 to D-15 (in the morning). The tolerance and pharmacokinetics of THN201, compared with Donepezil alone and placebo, are evaluated repeatedly over the 15 days of treatment. On D-15, pro-cognitive activity is measured with a scopolamine screen, a reference model for evaluating the pro-cognitive activities of drug candidates in healthy volunteers.

Theranexus is a clinical-stage biopharmaceutical company that emerged from the French Alternative Energies and Atomic Energy Commission (CEA) in 2013. It develops drug candidates for the treatment of nervous system diseases. Theranexus identified the key role played by non-neuronal cells (also known as “glial cells”) in the body's response to psychotropic drugs (which target the neurons). The company is a pioneer in the design and development of drug candidates affecting the interaction between neurons and glial cells. The unique, patented technology used by Theranexus is designed to improve the efficacy of psychotropic drugs already approved and on the market, by combining them with a glial cell modulator. This strategy of combining its innovations with registered drugs means Theranexus can significantly reduce development time and costs and considerably increase the chance of its drugs reaching the market.
The proprietary, adaptable Theranexus platform can generate different proprietary drug candidates offering high added-value for multiple indications.
Theranexus is listed on the Euronext Growth market in Paris (FR0013286259- ALTHX).
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[1] Involvement of astroglial connexins in the efficacy of THN201 in neurocognitive disorders linked to Alzheimer's disease.

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  Original Source: THERANEXUS