News

Neurolixis offers a warm welcome to Mark S. Kleven, PhD, as Director of Operations.

Dr. Kleven has gained extensive experience in several biotech and pharmaceutical companies where he managed in vivo pharmacology programs, prepared FDA-compliant regulatory documents and interacted with funding agencies including NIH and Dept of Defense. His project management expertise will be valuable as Neurolixis increases the scope of its programs in both the EU and the USA by developing clinical candidates targeting Parkinson's disease and Rett syndrome and also in characterizing development candidates from its proprietary drug discovery program.

See more information concerning Neurolixis' management team here.

A new study on NLX-112 tested its effects in marmosets with Parkinson’s-like symptoms. The marmosets had developed the side effect of dyskinesia in response to L-DOPA treatment, in a similar way to many people with Parkinson’s. The results showed that NLX-112 successfully reduced dyskinesia and, crucially, did not significantly reduce the effectiveness of L-DOPA, which many other similar drugs do. When NLX-112 was used on its own (without L-DOPA), it again improved movement problems. These promising results suggest that NLX-112 has potential as a future treatment for not only reducing dyskinesia, but also for improving the movement symptoms of Parkinson’s.

Adrian Newman-Tancredi, CEO of Neurolixis commented, “We are excited that NLX-112 has shown such positive results. If the striking preclinical data are reproduced in clinical trials, NLX-112 could significantly alleviate the troubling dyskinesia that prevent many Parkinson’s patients from performing routine daily tasks, thereby improving their quality of life.”

Full Press Release: Promising drug could treat Parkinson's
Full publication:  Neuropharmacology Vol. 167, 1 May 2020

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Adrian Newman-Tancredi, PhD, DSc, will present on novel antidepressant drugs at the forthcoming European College of Neuropsychopharmacology (ECNP) Congress to be held on 7-10 September in Copenhagen, Denmark. Together with Prof. Luc Zimmer of the Cermep Brain Imaging center (Lyon, France), Dr. Newman-Tancredi will lead a 'Brainstorming Session' on rapid-acting antidepressant drugs (RAADs) such as ketamine. Drug discovery efforts at Neurolixis have identified novel 'biased agonists', e.g. NLX-101, that show striking antidepressant activity in animal models. Moreover, the session will discuss how brain imaging technologies, including PET, fMRI and fUS, can help investigate brain region-specific effects of novel antidepressants.

Brainstorming session BS.02
Title: "The search for safe and rapid-acting antidepressants in the post-ketamine era: challenges for biased agonists"
Date: Sunday 9 September at 7h45 am, Room B2.
Chair: Kamilla Miskowiak, Professor of Cognitive Neuropsychiatry at the University of Copenhagen.

For full details of the session see the meeting website.

 

NLX-101, the first-in-class 'biased agonist' drug candidate, showed very rapid and long-lasting antidepressant activity in a robust rodent model of depression. The study, published in the Journal of Psychopharmacology, showed that NLX-101 produced complete reversal of depressive-like behavior in rats subjected to chronic mild stress within 1 day. Furthermore, the antidepressant-like activity of NLX-101 was maintained for several weeks after cessation of drug administration, suggesting a long-lasting remodeling of neuronal networks controlling some aspects of mood. NLX-101 also rescued cognitive function that had been impaired by  chronic mild stress.

The experiments were conducted in the laboratory of Prof. Mariusz Papp (Institute of Pharmacology, Polish Academy of Sciences, Krakow, Poland), a leading researcher in the field of antidepressant drugs. Prof. Papp commented: "The chronic mild stress model is highly validated and predictive of human antidepressant efficacy. Our laboratory has tested many antidepressant drugs, including reuptake inhibitors and ketamine, using the same conditions as those we used for NLX-101. However, none of the other drugs exhibited such rapid effects as NLX-101."

Cortical 5-hydroxytryptamine 1A receptor biased agonist, NLX-101, displays rapid-acting antidepressant-like properties in the rat chronic mild stress model.
Depoortère R, Papp M, Gruca P, Lason-Tyburkiewicz M, Niemczyk M, Varney MA, Newman-Tancredi A.
J Psychopharmacology. 2019. doi: 10.1177/0269881119860666. PMID:  31290370

Full Press Release Here.

The United States Patent and Trademark Office (USPTO) has just issued a patent on NLX-112 (aka befiradol), a drug developed by Neurolixis for treatment of dyskinesia in Parkinson's disease. The invention is based on a clinical trial which tested sustained release formulations of NLX-112, showing that they avoided side effects of dizziness and nausea. The issuance of the patent (US 10,548,885 B2) protects NLX-112 in the US until 2035. The patent has already issued in the European Union, Canada, Australia and Russia, and is pending in other territories.

Adrian Newman-Tancredi, PhD, DSc, CEO of Neurolixis commented, “We are delighted that the patent has issued in the US. Movement disorders are a major healthcare challenge, particularly among aging populations in developed nations, and this patent strengthens the commercial prospects of NLX-112 in a major pharmaceutical market.”

Full patent information: WO2016005527A1: Method for treating movement disorders with befiradol

Neurolixis a reçu une subvention de $861,000 du Programme de Recherche Médicale dirigé par le Ministère de la Défense des Etats Unis pour étudier les effets du NLX-112 en tant que traitement potentiel de la maladie de Machado Joseph, un trouble du mouvement génétique rare et grave. Le NLX-112 est un agoniste des récepteurs de la sérotonine 5-HT1A exceptionnellement sélectif et efficace, qui a déjà montré une activité prometteuse dans des modèles de Maladie de Parkinson. Le NLX-112 pourrait également être bénéfique pour le traitement d'autres troubles du mouvement, y compris la maladie de Machado Joseph.

Lire le communiqué de presse complet ici.

United States Department of Defense Seal.svg

 

Neurolixis CEO, Mark A. Varney PhD, was awarded a prize at an "Investor Speed Dating" event organized by Orange County Startup Council and supported by the Tech Coast Venture Network. Over 100 local companies participated as well as over 40 investors. Dr. Varney presented the drug development programs on NLX-112, which is being developed by Neurolixis for treatment of dyskinesia in Parkinson's disease.

Read the Orange County Startups article here.

La recherche sur le NLX-112, une molecule en dévéloppement par Neurolixis pour le traitement de la maladie de Parkinson, a été mise en valeur par la Technopole de Castres-Mazamet dans un entretien et un article sur son site web. En particulier, l'entretien attire l'attention sur la récente levée de fonds par Neurolixis auprès du Département de la Défense des Etats Unis
La Technopole de Castres-Mazamet propose du soutien dans la demande de subventions régionales, le recrutement et le networking professionnel.

Voir l'article complet ici.

 

The Neurolixis lead compound, NLX-112, is at the heart of a new brain imaging investigation of functionally-active serotonin 5-HT1A receptors in humans. NLX-112, also known as befiradol or F13640, was radiolabeled and administered to healthy adults as part of an ongoing clinical study led by Prof. Luc Zimmer of the Cermep brain imaging center in Lyon, France.

The study shows that, unlike previous radiotracers, 18F-labeled NLX-112 binds to 5-HT1A receptors which are functionally-responsive, and shows accentuated labeling in specific cortical brain regions. The first data from the study were published as the 'Image of the month' in the 'European Journal of Nuclear Medicine and Molecular Imaging'. 

18F-F13640 PET imaging of functional receptors in humans
Colom M., Costes N., Redouté J., Dailler F., Gobert F., Le bars D., Billard T., Newman-Tancredi A., Zimmer L. 
Eur J Nucl Med Mol Imaging (2019). https://doi.org/10.1007/s00259-019-04473-7

Full Press Release Here.

The US Food and Drug Administration (FDA) approved Neurolixis’ Investigational New Drug (IND) application for NLX-112. The FDA authorized a Phase 2 clinical study in Parkinson's disease patients with troublesome L-DOPA-induced dyskinesia. Neurolixis has previously shown that NLX-112 exhibits robust anti-dyskinetic activity in preclinical models of Parkinson's disease, without interfering with L-DOPA’s therapeutic properties. The planned clinical trial will investigate for the first time the safety and efficacy of NLX-112 in Parkinson's disease patients. Preparation and submission of the IND application was supported by funding from Parkinson’s UK, a non-profit charity which aims to improve life for everyone affected by Parkinson's disease through pioneering research and support services.

NLX-112 (also known as befiradol) acts on the brain’s serotonin system, and is a specific and efficacious activator of neuronal proteins known as 5-HT1A receptors. By targeting these receptors, NLX-112 inhibits L-DOPA-induced dyskinesia. NLX-112 is orally-administered and has previously been shown to be safe and well-tolerated in over 500 human subjects.

Read the full Neurolixis Press Release here.

Read the Parkinson’s UK announcement here.