FDA Approves Neurolixis IND Application for a Clinical Trial with NLX-112 in Parkinson's Disease

DANA POINT, Calif. - March 12, 2019 - PRLog -- The US Food and Drug Administration (FDA) gave a positive response to Neurolixis' Investigational New Drug (IND) application for NLX-112. The FDA issued a 'May Proceed' notification for a Phase 2 clinical study in Parkinson's disease patients with troublesome L-DOPA-induced dyskinesia (LID). 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 charity which aims to find a cure and improve life for everyone affected by Parkinson's through pioneering research, and by providing support services.

Dr Mark A. Varney, Chief Executive Officer of Neurolixis, commented: "We are excited to receive the FDA's decision which opens the way for us to conduct a proof-of-concept trial on NLX-112. If its striking preclinical profile translates to a clinical setting, NLX-112 could significantly improve the quality of life of many Parkinson's disease patients for whom dyskinesia prevents them from performing routine daily tasks. We are grateful to Parkinson's UK for their support and look forward to initiating a Phase 2 clinical study with NLX-112 later this year."

Dr Arthur Roach, Director of Research at Parkinson's UK, said: "Dyskinesia is one of the most debilitating side effects of Parkinson's medication. Parkinson's UK provided charitable funding of more than $1million (£780,000) for Neurolixis to carry out the final research needed on NLX-112 before it could be considered by the FDA, and we're delighted that this has helped get the drug to the next stage in its development. Through our Virtual Biotech program, we're aiming to invest $29million (£22 million) by the end of 2021 to support projects and companies like Neurolixis that are driving towards important new treatments with the potential to transform the lives of people with Parkinson's."

About NLX-112
NLX-112 (also known as befiradol) acts on the brain's serotonin system, and is a particularly specific, efficacious activator of neuronal proteins known as 5-HT1A receptors. By targeting these receptors, NLX-112 inhibits LID symptoms. NLX-112 is orally-administered and has previously been tested in over 500 human subjects. Neurolixis plans to investigate the antidyskinetic activity of NLX-112 in patients with Parkinson's disease.

About Parkinson's disease and L-DOPA-induced Dyskinesia
Parkinson's is a degenerative neurological condition, for which there currently is no cure. The main symptoms of the condition are tremor, slowness of movement and rigidity. L-DOPA-induced dyskinesia (LID), which can be severely disabling, are involuntary movements that commonly occur in Parkinson's patients after several years of treatment with therapies such as L-DOPA. The occurrence of LID can limit the dosing of L-DOPA, which may result in inadequate control of parkinsonian symptoms. The safe and effective treatment of LID remains a high unmet need in the Parkinson's community.

About Neurolixis, Inc.
Neurolixis, located in Dana Point, California, is a privately held biotechnology company developing therapies for disorders of the central nervous system. The Company has two clinical programs: NLX-112 is a Phase 2-ready program targeting LID, and NLX-101 is a Phase 1 drug candidate targeting Rett syndrome. Additional discovery programs target psychiatric disorders such as depression and schizophrenia. Further information is available at www.neurolixis.com

About Parkinson's UK
Parkinson's UK is the UK's leading charity supporting those with the condition. Its mission is to find a cure and improve life for everyone affected by Parkinson's through pioneering research, information, support and campaigning. Parkinson's UK is looking for further partners to help it create a portfolio of projects that can attract further investment and take successful projects into the later stages of drug development and trials. For more information visit: www.parkinsonsvirtualbiotech.co.uk

Forward Looking Statement
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. Neurolixis disclaims any intent or obligation to update these forward-looking statements.