Results from the company’s trial examining the drug in 586 patients with early-stage Parkinson’s disease found that the drug was able to show some success in its primary endpoint. Credit: Shutterstock / Inside Creative House

Irish late-stage clinical biotechnology company, Prothena Corporation, has announced results from its Phase IIb study of prasinezumab failed to meet its primary endpoint in a trial of patients with Parkinson’s disease.

Carried out in partnership with pharmaceutical giant Roche, results from the company’s trial examining the drug in 586 patients with early-stage Parkinson’s disease found that the drug was able to show some success in its primary endpoint in extending the time to a confirmed instance of motor progression of the disease.

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However, the company has said the drug fell short of expectations, with results from the PADOVA study (NCT04777331) finding the effect of prasinezumab was more pronounced in a pre-specified analysis in the population treated with levodopa. However, the company has also said that the drug showed some success in its secondary endpoints finding it to be well tolerated with no new safety signals emerging.

Now, the company has said that, alongside Roche, it is analysing the data which will be fully announced at an upcoming meeting. The company will examine plans to push prasinezumab as a potential first-in-class disease-modifying treatment for patients living with Parkinson’s disease.

Gene Kinney, president and chief executive officer for Prothena, said: “The results from the Phase IIb PADOVA study are a significant step forward to potentially bring the first disease-modifying treatment option to the millions of individuals living with Parkinson’s disease and their families.

“As pioneers in developing the first anti-alpha synuclein targeting antibody, we look forward to Roche presenting the results from the PADOVA study at an upcoming medical conference and sharing with health authorities to determine the most appropriate path forward.”

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The Phase II PASADENA (NCT03100149) and Phase IIb PADOVA open-label extension studies will continue, with four-year data from the PASADENA similarly showing evidence of sustained slowing of motor progression symptoms.

As part of the PADOVA trial patients were randomised to receive either monthly intravenous doses of prasinezumab 1500mg or placebo every four weeks for at least 76 weeks. This will be followed by a two-year open-label extension phase in which all patients receive active treatment.

Elsewhere in the field of Parkinson’s disease, Belgian pharmaceutical company UCB is dropping its development of minzasolmin in patients with Parkinson’s’ disease after the ORCHESTRA study failed to meet its primary and secondary endpoints. Meanwhile, Mitsubishi Tanabe Pharma America (MTPA) has announced that a Phase III trial of its candidate ND0612 has met its primary endpoint.