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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.