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 The leading web portal for pharmacy resources, news, education and careers March 23, 2019
Pharmacy Choice - Pharmaceutical News - FDA Approves Neurolixis IND Application for a Clinical Trial with NLX-112 in Parkinson`s Disease [Tehran Times (Iran)] - March 23, 2019

Pharmacy News Article

 3/14/19 - FDA Approves Neurolixis IND Application for a Clinical Trial with NLX-112 in Parkinson`s Disease [Tehran Times (Iran)]

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."



(c) 2019 TehranTimes. All Rights Reserved. Provided by SyndiGate Media Inc. (Syndigate.info).

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