Roche’s therapy shows promise in slowing Parkinson’s disease motor progression: GlobalData – Pharma News

There are currently no marketed disease-modifying therapies (DMTs) for Parkinson’s disease (PD). At the American Academy of Neurology (AAN) 2024 annual meeting, Roche presented positive outcomes from the trial evaluating the efficacy of PRX-002 (prasinezumab), a potentially PD-modifying monoclonal antibody.

These latest results strengthen the hope that PRX-02 will be able to slow PD motor progression, according to GlobalData, a data and analytics company.

“While the first 52 weeks of the PASADENA trial were randomized, double-blind, and placebo controlled, subsequent years had all participants receiving prasinezumab in an open-label extension where long-term follow-up outcomes were presented. With no control arm present, Roche selected to use an open access dataset from the Parkinson’s Progression Marker Initiative [PPMI] observational study,” Lorraine Palmer, Pharma Analyst at GlobalData, said in a statement.

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To support the validity of the comparison to the external control, Roche applied the same inclusion and exclusion criteria to the PPMI cohort as was applied to the PASADENA cohort, GlobalData revealed. Subsequently, propensity score weighting was applied to mimic the characteristics of a randomized controlled trial that compared the baseline characteristics and progression over one year of the PPMI cohort with the PASADENA placebo group from the first year.

“A potential treatment effect on disease progression can only be measured when participants in the placebo group progress sufficiently toward the endpoint of interest. Since this didn’t happen in the first year of PASADENA trial with the MDS-UPDRS Parts I and II secondary endpoints, these endpoints cannot be used to evaluate the effect of PRX-002 on PD progression for the first year. The reliability of the first-year readout for the primary endpoint is contentious. Additionally, positive outcomes from the first-year readout for the MDS-UPDRS Part III secondary endpoint suggested PRX-002 led to a slowing of PD progression. The inconsistencies in the year one results suggest that the open-label extension of the study to obtain longer-term outcomes was warranted,” Palmer said.

According to GlobalData, with the longer-term follow-up results from the open-label extension announced at AAN 2024, a significant shift can be seen in the treatment effect from three years of treatment onwards.

Palmer adds: “Besides indicating positive outcomes with PRX-002, the results following the extension of the PASADENA trial highlight that in order to effectively measure the potential DMTs on the progression of patient-reported motor symptoms, functional activity of daily living, and the progression of non-motor symptoms, studies running for longer than one-year may be required.”

In addition, KOLs interviewed by GlobalData have stated high hopes for monoclonal antibodies targeting alpha-synuclein, such as PRX-02, for modifying-disease progression and offering neuro-protective effects, it stated.

Palmer concludes: “As an open-label exploratory extension, the results presented by Roche should still be treated as preliminary. However, considering that even prior to these latest results, PRX-002 was unanimously highly regarded by KOLs who were hopeful about its potential as a DMT offering neuroprotection, the recent results from the PASADENA extension greatly raises the anticipation for the conclusion of PADOVA, the ongoing Phase IIb trial evaluating PRX-002.”