Roche reports the Prasinezumab aids in early-stage Parkinson's
The main goal of the Phase IIb study wasn't met with statistically significant results, but there is still some good news
On Dec. 18, 2024, Roche shared results from a Phase IIb study (PADOVA) where prasinezumab, an investigational monoclonal antibody (mAb), did not meet the study’s primary endpoint as it failed to achieve statistical significance. A total of 586 patients diagnosed with early stage Parkinson’s disease (PD) received treatment for at least 18 months while maintaining consistent symptomatic care. Prasinezumab showed promise in its main goal—time to confirmed motor progression—with a hazard ratio (HR)=0.84 [0.69-1.01] and p=0.0657, which did not reach statistical significance, as stated in a company press release. The analysis showed that prasinezumab had a stronger effect in patients treated with levodopa, as seen in 75% of the participants, with results indicating an HR of 0.79 [0.63-0.99]. It was noted that there were steady positive trends in several secondary and exploratory endpoints.
Prasinezumab is easy to tolerate, and the study did not show any new safety concerns. Roche is looking closely at the data and will collaborate with health authorities to decide on the next steps.
“Parkinson’s is complicated and has a significant impact, with no treatments available that can change the course of the disease for the millions affected,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, Roche, in the press release. “We think the ongoing effectiveness patterns from the Phase IIb study of prasinezumab deserve more investigation. We will keep working closely with the Parkinson’s community as we look at the data to decide what to do next.
Both the Phase II study (PASADENA) and this Phase IIb study (PADOVA) will allow Roche to further investigate the effects noted in both studies. The complete results from the Phase IIb (PADOVA) study will be shared at an upcoming medical meeting.
Prasinezumab is involved in an agreement for licensing, development, and commercialization that Roche has established with Prothena, a biotechnology company from Ireland that specializes in late-stage clinical work related to protein dysregulation. According to the agreement made in December 2013, the companies plan to create and market mAbs that focus on α-synuclein, a protein found in presynaptic neurons that is connected to PD through genetics and neuropathology. Prasinezumab focuses on the accumulation of α-syn protein in the brain, which may help stop additional build-up and the spread between cells. This step can help slow the disease's progression.
Source: Roche
