[Hørsholm, May 21st, 2024] – Contera Pharma A/S, a biotech company developing innovative therapies to treat neurological disorders, announce topline results from the ASTORIA Phase IIb trial of JM-010 in people suffering from dyskinesia in Parkinson´s disease.
The main objectives of the trial were to investigate efficacy and safety of two doses of JM-010, compared to placebo, in people with Parkinson´s disease dyskinesia. The primary efficacy endpoint, reduction of dyskinesia as assessed by the Unified Dyskinesia Rating Scale (UDysRS) was not met. At 12 weeks, nominal reductions of 0.3 and 4.2 points in change from baseline UDysRS total scores versus placebo were observed for the two JM-010 doses, respectively; however, the differences were not statistically significant.
Both doses of JM-010 were well-tolerated and no serious treatment-related adverse events were observed in the study.
“Unfortunately, the primary endpoint assessing reduction in dyskinesia as evaluated by the UDysRS was not met. The ASTORIA trial was well conducted, and we will look into the results in more detail to fully understand the outcome of the study. Meanwhile, we would like to express our sincere gratitude to the patients, investigators and our JM-010 alliance partner Bukwang for their commitment to the study“, said Kenneth Vielsted Christensen, CSO and Head of R&D, Contera Pharma.
Further analysis of the full dataset from ASTORIA including secondary endpoints is currently ongoing and full disclosure of the detailed results from the Phase IIb trial will be published at future scientific congresses and peer-reviewed publications.
“We are of course disappointed with the outcome of the ASTORIA trial”, said Thomas Sager, CEO, Contera Pharma. “Despite this setback, we remain fully committed and will continue advancing our other clinical stage program CP-012 addressing morning akinesia in Parkinson´s disease and are excited about the progress we see in our preclinical pipeline within rare neurological disorders.”
About the study
The ASTORIA trial is “A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson’s Disease Patients with Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations of JM-010”. The study targets 81 Parkinson’s disease patients and involves 38 clinical sites across Europe and Asia, including the following countries: Germany, France, Italy, Spain and Slovakia and Korea.
More information on the study can be found on clinicaltrials.gov: NCT03956979
About Contera Pharma A/S
Contera Pharma A/S is focused on developing new treatments for people suffering from neurological disorders. Contera Pharma’s science is based on a precision medicine approach integrating external and internal data sources to support rational selection of human disease-validated drug discovery targets to identify novel pipeline opportunities within neurological disorders. The company’s lead assets, JM-010, is currently in Phase IIb clinical testing for Parkinson’s disease dyskinesia. Contera Pharma was founded in 2010 and has offices in Hørsholm, Denmark and Seoul, South-Korea.
