PsychoGenics, a preclinical contract research organisation, has announced positive results from the study evaluating eltoprazine in levodopa induced dyskinesia (LID) in Parkinson’s disease (PD) patients.
Eltoprazine, a selective 5-HT1A/1B partial agonist, met the primary objective of the study and was well tolerated with no serious adverse events reported.
PsychoGenics president and CEO, Emer Leahy, said the results of this trial are compelling and show that eltoprazine has the potential to address a critical unmet need in Parkinson’s disease.
"With these promising positive data we now intend to progress eltoprazine to market as quickly as possible with support from a partner," Leahy added.
Eltoprazine exhibited a statistically significant reduction in LID at the 5mg dose (p = 0.0007) and the 7.5mg dose (p = 0.0467), without adversely affecting levodopa efficacy, thereby achieving the primary objective.
The double-blind, placebo-controlled, dose-finding study, conducted at two sites in Sweden, randomised twenty-two patients.
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The subjects were dosed with eltoprazine and placebo, along with a challenge dose of levodopa at each of the five treatment visits.
The study assessed parkinsonian and dyskinesia symptoms over a period of three hours post-treatment and the assessments were video-taped and scored by two independent blinded raters.
The Clinical Dyskinesia Rating Scale (CDRS) and the Unified Parkinson’s Disease Rating Scale (UPDRS) were used to measure the primary efficacy.
Secondary endpoints comprised the Rush Dyskinesia Rating Scale and evaluation of the patients’ mood using the Hospital Anxiety and Depression Score (HADS) and Montgomery-Asberg Depression Rating Scale (MADRS).
The Michael J Fox Foundation for Parkinson’s Research partially supported the trial with a grant.
The Michael J Fox Foundation CEO, Todd Sherer, said: "The results presented by PsychoGenics and Dr Bjorklund show early promise in finding a potential treatment for dyskinesia and we look forward to working with this team to drive their program forward."