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[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
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