Two nonprofits, Parkinson’s U.K. and The Michael J. Fox Foundation have partnered with Neurolixis to support a clinical trial testing the safety, tolerability, and early efficacy of NLX-112, the company’s candidate to ease dyskinesia and the severity of some non-motor symptoms due to Parkinson’s disease.
Data from this study may allow Neurolixis’ NLX-112 to rapidly move NLX-112 into a larger Phase 3 trial, aiming to generate sufficient positive results to support the therapy’s approval.
“We’re delighted to be joining forces with The Michael J. Fox Foundation to drive forward a potentially life-changing new treatment for people with Parkinson’s,” Arthur Roach, director of Research at Parkinson’s U.K., said in a press release.
“We’re providing funding for this important study through our pioneering Parkinson’s Virtual Biotech which is working with partners worldwide to accelerate better treatments and a cure,” Roach said.
Altogether, the three organizations have raised £1.5 million (about $1.7 million) to fund the two-year study, where Neurolixis’ experimental therapy for levodopa-induced dyskinesia (LID) will be given to Parkinson’s patients for a first time.
“Levodopa-induced dyskinesia can significantly impact quality of life for people with Parkinson’s. This collaboration with Parkinson’s U.K. is about combining our resources to advance this promising therapeutic approach from Neurolixis as quickly as we can to benefit the patients and families worldwide who navigate dyskinesia in their daily lives,” said Todd Sherer, PhD, CEO of the Fox Foundation.
LID, a condition in which patients start having involuntary muscle movements, like jerking or twitching, that affect their ability to perform even simple tasks, is a common side effect of levodopa-based therapies — the main forms of treatment for Parkinson’s — among those who have been taking these medications for years.
Michael Gibson, 39 and diagnosed with Parkinson’s at age18, regularly experiences dyskinesia episodes.
“Dyskinesia is absolutely the worst part of having Parkinson’s for me. I’m naturally a very sociable, outgoing person, but it’s a huge knock to my self-confidence when I’m out with my kids and people stare or make awful remarks. I’ve been told, ‘You’re a disgrace’ because the sudden movements make people think I’m drunk,” Gibson said in the release.
“It’s an awful feeling and a constant reminder of my condition. Sometimes I don’t want to think about Parkinson’s, sometimes I just want to be me. But dyskinesia stops me from doing that,” he added.
LID is also thought to be associated with a dysregulation of serotonin-producing neurons. Recent studies have shown these neurons can take up levodopa and convert it into dopamine in an uncontrolled manner, contributing to the onset of the unintended movements that characterize dyskinesia.
NLX-112 is new compound that is able to selectively activate a sub-type of serotonin receptor called the 5-HT1A receptor, which is usually found in serotonin-producing neurons. Once active, this receptor interferes with serotonin signaling cascades in these nerve cells, lowering their activity. By reducing the activity of serotonin-producing neurons, NLX-112 is expected to alleviate symptoms of dyskinesia in people with Parkinson’s.
Preclinical studies supported by Parkinson’s U.K. have shown that NLX-112 was effective at easing dyskinesia in animal models of Parkinson’s. These findings provided the foundation for the launch of clinical trials testing NLX-112 in patients.
The clinical trial, which will be conducted by researchers at the Karolinska Institute in Sweden, will compare the safety and tolerability of NLX-112 to that of a placebo in 24 patients with dyskinesia.
It will also focus on assessing whether NLX-112 can ease dyskinesia, as well as some of Parkinson’s typical non-motor symptoms, including mood and sleep issues.
Study findings may enable NLX-112 to move into Phase 3 clinical testing, and potentially a request for its approval as a new disease treatment.
“We are excited to move to a proof-of-concept trial with NLX-112. The compound has a novel mechanism of action which has been extensively validated in laboratory tests,” Adrian Newman-Tancredi, CEO of Neurolixis, said in a separate release. “If the positive effects seen in the lab translate into a clinical setting, NLX-112 could significantly improve the quality of life of many people with Parkinson’s.”
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