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The Craig H. Nielsen Foundation, a private institution dedicated to supporting scientific research and improve the quality of life of those affected spinal cord injury, has awarded a $ 641,000 grant to investigate the capacity of NLX-112, a clinical-phase compound developed by Neurolixis, to restore bladder function in rodent models of spinal cord injury. Experiments will be carried out by a research team at Cleveland Clinic, Ohio, led Dr. Yu-Shang Lee.

Dr Lee commented “There are about 17,700 new cases of spinal cord injury in the US each year and over 250,000 new cases worldwide. Many complications arise from such injury, including lower urinary tract dysfunction with bladder over activity and poor voiding efficiency. These complications have significant negative impact on the quality of life of patients and there is a high medical need for effective treatments.”

Adrian Newman-Tancredi, PhD, DSc, CEO of Neurolixis, commented: “Previous studies conducted by Neurolixis have shown that NLX-112 has pronounced influence on spinal cord responses, including expression of biological markers and analgesic activity. These data suggest that NLX-112 has a mechanism of action that can attenuate spinal cord injury-induced urinary tract dysfunction.”

In addition to testing the effects of NLX-112, Dr. Lee will also investigate potential synergy of NLX-112 in combination with exercise training. If successful, such treatment strategies could be translated into a clinical setting by testing NLX-112 in patients with spinal cord injury.

See the full description of the Craig Nielsen Foundation grant here.

 

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.

Neurolixis' development of NLX-112, a drug candidate for treatment of dyskinesia in Parkinson's disease and other movement disorders, was showcased by the Castres-Mazamet Technopole, a French regional entrepreneur accelerator in a video interview and article. In particular, these highlighted the recent financial support received by Neurolixis from the US Dept of Defense. The accelerator assists the French branch of Neurolixis in fundraising, recruitment and business networking.

See the full article here.

 

Neurolixis Inc. has been awarded a $861,000 grant by the US Department of Defense Congressionally Directed Medical Research Program to investigate the effects of NLX-112 as a potential treatment for Machado Joseph disease, a serious and rare genetic movement disorder. NLX-112 is an exceptionally-selective and efficacious serotonin 5-HT1A receptor agonist which has already shown promising activity in models of Parkinson's disease. It is anticipated that NLX-112 could also be beneficial for treatment of other movement disorders, including Machado Joseph disease.

Read the full press release here.

United States Department of Defense Seal.svg

 

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

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.

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.

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