BDD’s OralogiK™ technology dosed in Parkinson’s patients for the first time. – Phase 1b trial of CP-012

Contera Pharma A/S, a clinical-stage biotech company pioneering innovative treatments for neurological disorders, has announced the dosing of the first patient in a Phase 1b pharmacoscintigraphic study evaluating CP-012. This novel delayed-release, dual-pulse levodopa/carbidopa tablet is designed to address the distinct challenges of nocturnal immobility and early morning akinesia in Parkinson’s disease (PD) patients. These motor complications cause significant disability and severely impact patients’ quality of life, underscoring the urgent need for new therapeutic options.

“The dosing of the first subject in this important study marks a significant milestone for our CP-012 program and reinforces our ongoing commitment to delivering novel treatment solutions for Parkinson’s disease. Following the compelling data from our Phase Ia study in healthy volunteers, which showed that CP-012 was well tolerated, with a promising pharmacokinetic profile, we are excited to move forward into clinical evaluation in Parkinson’s patients. We are confident that CP-012 has the potential to address the critical unmet need of nocturnal and early morning motor complications, delivering levodopa/carbidopa when it is most needed. This innovative approach positions CP-012 as a promising future treatment for Parkinson’s disease, and we look forward to the continued progress of this study”, says Anne Birk Østerskov, CMO of Contera Pharma.

Thomas Sager, CEO of Contera Pharma, adds: “Our first patient dosed in the Phase Ib trial of CP-012 marks an important milestone in our mission to address Parkinson’s morning off symptoms. We look forward to advancing this program and engaging with future pharma partners to drive CP-012 further into clinical development”.

About the study
The study is an exploratory pharmacoscintigraphic single centre, open-label, crossover study in up to 15 patients. 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. The study will be conducted in collaboration with BDD Pharma, and executed at their clinical site in Glasgow, Scotland.

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. 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 Contera Pharma A/S
Contera Pharma A/S is focused on developing novel 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. CP-012 is an investigational drug that is not approved for use by any regulatory authorities. Contera Pharma has full ownership and holds global rights to the CP-012 program (Contera Pharma holds a license to BDD Pharmas formulation technology, OralogiK). Contera Pharma is based in Hørsholm, Denmark.

For more information, visit www.conterapharma.com