CP-012

[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.

Contera Pharma, a biotech company developing innovative therapies to treat neurological disorders, and BDD Pharma, a drug delivery company specializing in modified and controlled release oral formulations, announce dosing of first subject in a Phase 1 pharmacoscintigraphic study in healthy volunteers. The study will evaluate a novel delayed-release, dual pulse levodopa / carbidopa tablet (CP-012), designed to specifically treat Parkinson´s disease (PD) patients suffering from nocturnal or early morning motor complications known as morning akinesia. These night-time and early morning immobility episodes are causes of significant disability, in addition to having a negative impact on quality of life for the patient. “The dosing of the first subject in this important study represents a significant milestone in this project and mark our maintained commitment to identify and deliver novel treatment solutions to Parkinson´s disease patients. We are delighted to begin clinical evaluation of CP-012 and are excited that we have been able to push this project forward through tablet prototyping, tablet development and further into explorative clinical testing in roughly 12 months. We believe that CP-012 has the potential to be an effective and reliable solution against nocturnal and early morning mobility problems, a persistent unmet need in Parkinson´s disease, by delivering levodopa/carbidopa when it is needed, and that this treatment concept is likely to find a prominent role in future clinical practice. By utilizing BDDs specialized technology we have been able to accelerate the development of this novel treatment option and we look forward to continuing the collaboration with BDD during the execution of this study”, says Thomas Sager, CEO of Contera Pharma. Carol Thomson, CEO of BDD Pharma said “We are incredibly proud and excited to reach this critical milestone in our ongoing collaboration with Contera Pharma. The first dosing of a new product is always exciting for us but particularly so with this innovative Parkinson’s product, which is made possible by BDD’s timed release technology, OralogiK™. This project is a prime example of how BDD can leverage its combined formulation development, GMP manufacture and clinical trial setup to accelerate the journey for products like CP-012 from formulation to clinic.” About the study The study is an exploratory pharmacoscintigraphic single centre, open-label, crossover study in up to 15 healthy volunteers. The primary objective of the study is to evaluate the absorption (PK) of levodopa and carbidopa from two, novel delayed pulsatile release CP-012 formulations and correlate with scintigraphic time and site of release. About morning akinesia Mobility problems and recurring tremor early in the morning before the first intake of levodopa are early events in the development of motor complications associated with sustained oral levodopa treatment of PD. Recent surveys have indicated that early morning akinesia (or morning OFF episodes) are present in around 60% of PD patients across all disease stages and that a similar number of patients are affected by nocturnal immobility with difficulties turning in bed. Importantly, in most patients experiencing early morning akinesia, this is associated with non-motor symptoms such as anxiety, depression, pain, and urinary urge. Taken together, nocturnal immobility and morning akinesia are significant contributors to impaired sleep quality and reduced quality of life for patients. There are currently no effective, reliable, and easy to use treatment options available to satisfactorily address these problems. About BDD BDD Pharma Ltd is a privately-owned drug delivery company specializing in the development of modified and controlled release oral formulations. BDD’s OralogiK™ technology is a tablet-in-tablet drug delivery system providing timed release, targeted release and the opportunity for complex bi- and tri-phasic release of one or multiple drugs. The OralogiK™ technology is protected with granted patents across a number of territories including the US, EU and Japan. Supported by investment from Archangels, the Scottish Investment Bank, Alderley Park Ventures and BioCity Investments, BDD has in-house clinical trial capabilities for the conduct of gamma scintigraphic/ pharmacokinetic studies in humans. BDD’s SWIFT adaptive clinical trials integrate formulation development, GMP manufacturing and clinical testing into one streamlined service, offering a more flexible approach than the conventional clinical trial design structure. 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 asset, 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.