JM-010

[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.

[Hørsholm, January 17th, 2024] – Contera Pharma A/S, a biotech company developing innovative therapies to treat neurological disorders, announce enrolment of the last patient in its Phase 2b clinical trial ASTORIA. The trial aims to evaluate the efficacy of JM-010, a novel therapeutic solution designed to specifically address the pathophysiology underlying Parkinson’s disease dyskinesia. This milestone is an important achievement for the continued development of JM-010. “We are excited to reach this pivotal moment in our clinical trial for JM-010. The enrolment of the last patient marks a significant step forward in our mission to bring innovative and effective treatments to those patients in need”, says Kenneth Vielsted Christensen, CSO and Head of R&D, Contera Pharma.” The completion of patient enrolment represents a key achievement in the overall progress of the ASTORIA trial, showcasing the commitment and dedication of the clinical investigators and the participating patients. Topline results from the European JM-010 study are expected second half of 2024. “I am thrilled to announce this milestone and looking forward to communicating the study results during the latter half of this year, says Thomas Sager, CEO, Contera Pharma. “On behalf of the whole Contera Pharma team, I would also like to extend our gratitude to the patients, healthcare professionals, our alliance partner Bukwang and all stakeholders who have contributed to reaching this important stage.” More information on the study can be found on clinicaltrials.gov: ID NCT03956979 About JM-010 and PD dyskinesia JM-010 is a proprietary formulation combining immediate-release buspirone and extended-release zolmitriptan for the treatment of dyskinesia associated with dopamine replacement therapies such as levodopa in Parkinson’s disease (PD). In preclinical models of PD dyskinesia, the JM-010 combination shows a synergistic anti-dyskinetic effect and the treatment principle is further supported by Ph2a proof-of-concept and Ph1 pharmacokinetic clinical trials demonstrating a significant anti-dyskinetic effect, no safety concerns and good tolerability. Contera Pharma co-develops JM-010 with its alliance partner Bukwang Pharmaceuticals. The companies aim to deliver JM-010 as a ‘best-in-class’ treatment option, offering a better solution to treat dyskinesia in PD patients than current standard of care. 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. 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.