12 March 2019 - FDA approves Neurolixis IND application for clinical trial with NLX-112

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.

18 February 2019 - Neurolixis launches NLX-112 drug formulation collaboration with GALA® laboratory in France

Neurolixis launched a collaboration with the GALA® laboratory in Castres, France. GALA® is a platform of the Rapsodee/IMT Mines Albi research facility and has experimental tools and skills across a wide range of drug formulation technologies.

The Neurolixis-GALA collaboration focuses on the development of a novel formulation of NLX-112. This compound is in clinical development for treatment of dyskinesia (abnormal movements) seen in patients suffering from Parkinson's disease and the new formulation will optimize its therapeutic activity and facilitate its administration to patients. The development of NLX-112 has been supported by grants from the Michael J. Fox Foundation (USA) and Parkinson's UK. The Neurolixis-GALA collaboration is financed by subsidies from the Occitanie Region in France.

Adrian Newman-Tancredi, PhD, DSc, Chief Scientific Officer of Neurolixis, commented: "The development of a novel formulation of NLX-112 will be strong asset for the project and enable Parkinson’s disease patients (about 1 million in the USA) to maximally benefit from this innovative treatment.”