Neurolixis, Inc. today announced the positive results of its Phase 2A clinical trial with NLX-112 (befiradol), for treatment of levodopa-induced dyskinesias (LID) in Parkinson’s disease (PD).
NLX-112, a first-in-kind, highly selective serotonin 5-HT1A receptor activator, met the primary outcome of safety and tolerability and, in addition, showed statistically significant efficacy in reducing LID symptoms in Parkinson’s disease patients.
The study (ClinicalTrials.gov ID: NCT05148884) was a randomized, double-blind, placebo-controlled trial conducted at 5 centers in Sweden. 22 patients (15 on NLX-112, 7 on PBO) completed the 8-week treatment according to the protocol. Safety was good and did not differ between NLX-112 and placebo groups. Tolerability was favorable, there were no serious adverse events in the NLX-112 group. Beyond meeting the primary outcome of safety and tolerability, NLX-112 also achieved significant reductions in LID scores, whereas placebo group changes were not significant. Full analysis of efficacy measures is underway and will be disclosed in further announcements and at upcoming scientific conferences.
"We are excited about the positive results of this proof-of-concept study," said Prof. Per Svenninsson, Principal Clinical Investigator at the Karolinska institute in Stockholm. "The findings indicate that NLX-112 can be safely administered to people with PD and alleviates their troublesome LID. If these findings are confirmed in larger clinical trials, NLX-112 could become a promising new treatment option for this indication."
The study was financially supported by grants from Parkinson's UK and The Michael J. Fox Foundation, the two largest foundations for research on Parkinson's disease in the world.
Neurolixis plans to advance NLX-112 to a Phase 2B study to further evaluate the drug's efficacy and safety in a larger patient population.
See the full press release.