The expert medical director at Roche provided detail on results from the phase 2 PASADENA study presented at the 2021 MDS Virtual Congress. [WATCH TIME: 3 minutes]
WATCH TIME: 3 minutes
"For the new studies, we are planning to use this paradigm. Staying in the early stage, but focusing on those patients who still need symptomatic care."
The phase 2 PASADENA study (NCT03100149) was a randomized, placebo-controlled trial that evaluated the efficacy and safety of prasinezumab (Roche), an investigational humanized monoclonal antibody in patients with early-stage Parkinson disease (PD). Part 2 of the study randomized patients 1:1:1 to receive intravenous prasinezumab every 4 weeks (low dose [1500 mg] or high dose [3500 mg for body weight <65 kg or 4500 mg for body weight ≥65 kg) for 2 years (early-start group, n = 204) or placebo for 1 year, followed by low- or high-dose prasinezumab for 1 year (delayed-start group, n = 105).
At weeks 52 and 104, the early-start group showed an adjusted mean difference of –1.22 (standard error [SE], 1.08 [80% CI, –2.60 to 0.16]) and –1.93 (SE, 1.66 [80% CI, –4.07 to 0.20]), respectively, compared to those in the delayed-start group on Movement Disorder Society-Unified Parkinson’s Disease Rating Scale.Designed to bind to aggregated α-synuclein with higher selectivity over monomeric α-synuclein, the agent is thought to slow neurodegeneration associated with the protein’s toxic accumulation and its transmission to neighboring neurons.
Gennero Pagano, MD, MSc, PhD, expert medical director, Roche, sat down with NeurologyLive to provide thoughts on the results of the study and their clinical significance. He also discussed whether this is an agent that may show greater success if paired with other previously approved PD treatments.