Clinical Trial Results Suggest Teva’s Pridopidine May Delay Functional Decline in Huntington’s Patients
The latest results on the effectiveness and safety of pridopidine (called Huntexil in Europe) for the treatment of Huntington’s disease (HD) will be presented at the annual meeting of the American Academy of Neurology (AAN) April 22-28 Boston.
Pridopidine is an investigational drug that has the potential to modulate locomotor patterns of patients with neurodegenerative diseases. Teva Pharmaceuticals is exploring its therapeutic benefits for the treatment of Huntington’s symptoms.
Teva is a global pharmaceutical company and the world’s largest producer of generic medicine. It is focused on the development of new therapies for several central nervous system (CNS) disorders with unmet medical needs, such as multiple sclerosis, movement disorders, Huntington’s disease, and others.
“Teva is dedicated to the ongoing evaluation of its therapies to ensure the delivery of safe and effective treatments for often under-recognized or difficult-to-treat CNS disorders,” Michael Hayden, MD, PhD, Teva’s president of global research and development and chief scientific officer, said in a company press release.
“The data to be presented at AAN highlight our continued progress and comprehensive research across our CNS portfolio in order to grow our understanding of the potential of our therapies, and continue delivering therapies to patients in need,” he said.
Preclinical studies have shown that pridopidine can stabilize neurons, suggesting that it can have other effects beyond improving motor symptoms.
Results from Phase 2 PRIDE-HD study (NCT02006472) showed that although pridopidine treatment did not show significant effects improving the motor function of patients at endpoints of the study, it did improve their total functional capacity score, a measure of overall functional capacity. No major adverse side effects were reported during the trial, confirming the safety and tolerability of the drug.
Pridopidine’s capacity to improve the ability of Huntington’s patients to preform daily activities was confirmed by comparison analysis with other drug candidates tested in placebo-controlled trials.
Teva bought the rights to pridopidine from its developer NeuroSearch in 2012. In 2010, NeuroSearch announced results from the largest European Phase 3 clinical trial (MermaiHD) in Huntington’s carried out to that point. After evaluating the effects of pridopidine in Huntington’s patients after six months of treatment, the results showed pridopidine improved total motor symptoms, although the primary endpoint of the study was not met.
Another Phase 3 study confirming pridopidine’s potential to slow functional decline in Huntington’s is required before regulatory approval in the U.S. and Europe.
More detailed information on pridopidine data to be presented at the AAN meeting can be found in the following links:
- “Efficacy, Safety, and Tolerability of Pridopidine in Huntington Disease (HD): Results from the Phase II, Double-blind, Placebo-controlled, Dose-Ranging Study, Pride-HD”
- “Effect of Pridopidine on Total Functional Capacity (TFC) in Huntington Disease (HD): A Comparison of Open-HART Subjects with Historical Placebo Controls”