News

Leading charities Parkinson’s UK and The Michael J. Fox Foundation for Parkinson’s Research (MJFF) have joined forces with Neurolixis to fund a $2 million Phase 2A trial investigating the clinical effects of NLX-112. The compound has previously shown robust capacity for reducing  uncontrolled movements, known as dyskinesia. Dyskinesia is experienced by people with Parkinson's disease who have been treated for several years with levodopa - a standard treatment for Parkinson’s. Between 40 and 50 percent of people with Parkinson’s will experience dyskinesia after just five years of taking levodopa.

NLX-112 works by targeting brain neurons that produce serotonin. These neurons are believed to contribute to the development of dyskinesia by converting levodopa - the main drug taken for Parkinson’s - into dopamine and releasing it in an erratic manner. NLX-112 stabilizes the amount of dopamine these serotonin cells release.

The new study, led by a team at the Karolinska Institute in Sweden, will now assess whether NLX-112 is safe and well-tolerated in people with Parkinson's. The study will also  investigate whether NLX-112 can reduce dyskinesia as well as some non-motor symptoms, such as depressed mood and disturbed sleep.

See the full press release.

Neurolixis Inc. is delighted to announce the appointment of Dr. Christopher Jankosky, MD, MPH, as a member of its Advisory Board

Dr. Jankosky' career as a neurologist and occupational medicine expert in the U.S. Navy, together with his work in the FDA have given him a profound understanding of both CNS disorders and regulatory aspects of drug develoment. Dr. Jankosky's broad experience as a corporate medical advisor will provide valuable insights and facilitate the advancement of the Neurolixis programs.

See more information concerning Neurolixis' team here.

Neurolixis Inc. offers a warm welcome to Fabienne Herbrecht, as Director of Clinical Development.
Dr. Herbrecht has gained extensive experience of drug development at a clinical level in several large and medium-sized pharmaceutical companies where she managed development, regulatory and clinical programs on drug candidates. Her expertise will be valuable as Neurolixis moves forward with development of its drug pipeline, notably as concerns targeting Parkinson's disease with the Phase 2A clinical candidate, NLX-112.

See more information concerning Neurolixis' management team here.

 

A drug discovery program run by Neurolixis in collaboration with researchers at Jagiellonian University (Krakow, Poland) has identified the first selective serotonin 5 HT1A receptor 'biased agonists' targeting beta-arrestin activation. Serotonin (5-hydroxytryptamine, 5-HT) is a key brain neurotransmitter that acts by activating neuronal receptors such as 5-HT1A. Neurolixis has developed a platform of novel compounds, known as ‘biased agonists’ that preferentially target specific intracellular signaling cascades via 5-HT1A receptors. The new study, reported in the Journal of Medicinal Chemistry, describes novel biased agonists that very selectively and potently activate beta-arrestin, a signaling mechanism at 5-HT1A receptors that is different to that targeted by previous Neurolixis biased agonists that target ERK1/2 phosphorylation. Notably, the beta-arrestin biased agonists exhibited distinct effects in rodent behavioral tests, likely reflecting specific neuronal signaling properties. The discovery may to lead to a new generation of molecules that differentially modulate this important neuronal receptor.

Adrian Newman-Tancredi CEO of Neurolixis commented, “We are excited that our drug discovery program has generated innovative compounds that could be relevant for treatment of central nervous system disorders such as depression or chronic pain.”

See the full publication (open access):
Discovery of novel pERK1/2- or β-Arrestin-Preferring 5-HT1A Receptor Biased Agonists: Diversified Therapeutic-Like vs. Side Effects Profile.
Sniecikowska et al., J Med Chem. 2020 Sep 4. doi: 10.1021/acs.jmedchem.0c00814. PMID: 32883072

 

A new publication on NLX-112 further highlights its potential utility for treatment of dyskinesia (uncontrolled movements), a disturbing side effect of L-DOPA therapy in Parkinson's disease. NLX-112 was tested in parkinsonian macaques, a primate species that is highly predictive of response in human Parkinson's disease patients. When the macaques received NLX-112, their dyskinesia symptoms were  strongly reduced, confirming a previous study carried out in parkinsonian marmosets. Notably, NLX-112 did not interfere with the therapeutic movement facilitation produced by L-DOPA. Taken together, these results provide compelling support for testing NLX-112 in  Parkinson's disease patients. Safe and efficacious treatment of dyskinesia constitutes a clear medical need and NLX-112 could significantly improve the quality of life of Parkinson's disease patients. 

Full publication:  Depoortère et al. Parkinsonism and Related Disorders, vol. 78, p151-157, 2020

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.

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

No alt text provided for this imageNo alt text provided for this imageNo alt text provided for this image

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' 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.

 

Newsletter

Please enable the javascript to submit this form

Follow Neurolixis on: