The first participant has been recruited to a pioneering clinical trial which is testing a new drug called NLX-112 that could be used for people with Parkinson’s disease.
Parkinson’s disease is a condition in which parts of the brain become progressively damaged over many years. The main three symptoms manifest themselves in involuntary shaking of parts of the body, slow movement, and stiff, inflexible muscles.
People with Parkinson’s struggle to make enough dopamine. They take medications like levodopa which help their struggling dopamine cells to make more of this chemical and helps improve symptoms, especially difficulty in movement.
However, serotonin cells also get involved in using levodopa to make and release dopamine, but they do so in an erratic manner. This uncontrolled release of dopamine leads to distressing uncontrollable movements called dyskinesia.
The trial is led by researchers at the Karolinska Institute in Stockholm and at 4 other sites in Sweden. A total of 24 participants will be involved, with 16 receiving NLX-112 and the remainder an inactive pill (placebo) for comparison.
Promising new medication for Parkinson’s
NLX-112 has shown promising results in the lab for reducing dyskinesia caused by the medication Levodopa, which is a common and distressing side effect of current Parkinson’s medications. Dyskinesia causes involuntary movements that can affect various parts of the body, making simple, everyday tasks like tying your shoelaces difficult.
The clinical trial aims to assess whether NLX-112 is safe and well-tolerated by people suffering from Parkinson’s who also experience dyskinesia. It will also analyse how the drug can reduce dyskinesia and other non-motor symptoms such as depression and disturbed sleep.
Adrian Newman-Tancredi, PhD, DSc, Chief Executive Officer of Neurolixis, commented: “We are delighted that this important trial is now underway, and the first participant has been recruited. The pandemic has made getting to this point more challenging and time-consuming than we’d hoped, but we’re now keen to make up for lost time. If recruitment to the study progresses smoothly, we are hopeful that we will have results to share by late 2022.”
Funded by leading charities
Parkinson’s UK and The Michael J. Fox Foundation (MJFF), two leading charities have raised £1.5m ($2m) to fund the phase 2 clinical trial, which is being sponsored by the biopharmaceutical company Neurolixis.
Dr Arthur Roach, Director of Research at Parkinson’s UK, said: “We’re pleased to be supporting this study which aims to deliver a treatment that is desperately needed by many people living with Parkinson’s. It’s great that recruitment is now underway as this milestone brings us one step closer to results which could reveal an important new therapy for the millions living with this condition around the world.”
Marco Baptista, PhD, Vice President of Research Programs at MJFF, also said: “A treatment for dyskinesia would significantly improve the quality of life for millions with Parkinson’s who experience this common medication side effect. We are proud to partner with Parkinson’s UK and Neurolixis and with the study volunteers to advance this therapy in testing.”