Bial has reported new efficacy and tolerability data from Ongentys (opicapone), a catechol-O-methyltransferase (COMT) inhibitor, in Phase III studies involving patients with Parkinson’s disease (PD) and Movement Disorders (MDS).
The data is being presented at the MDS 2020 Virtual Congress from 12-16 September.
According to a new post-hoc analysis of the real-world OPTIPARK study, the majority of treatment-emergent adverse events (TEAEs) that are at least possibly related to opicapone occurred within the first week of treatment.
The data further revealed a consistently low incidence of TEAEs from the third week onwards for six months.
Bial added that dyskinesia was the most frequently reported TEAE during the first week of treatment but did not significantly impact patient discontinuation.
The company also analysed three additional datasets from the BIPARK-I and II trials of the drug as a first-line adjunctive therapy to levodopa in PD patients with motor fluctuations.
When compared to placebo and entacapone, opicapone was found to have shown added benefit in levodopa-treated PD patients recently diagnosed with motor fluctuations.
The drug also demonstrated an ability to decrease OFF-time as a first add-on to levodopa or in combination with levodopa regimens consisting of other anti-PD medications.
A home-diary data review involving 235 patients on 50mg of opicapone or entacapone in the BIPARK-I7 trial revealed that opicapone showed a greater increase in the proportion of patients who woke up in ON-status compared to entacapone.
The reduction in morning OFF-time was two times greater with opicapone than entacapone.
Bial Research & Development director Soares da Silva said: “Motor fluctuations can have a considerable impact on quality of life for people with Parkinson’s and our focus is on offering effective solutions with manageable tolerability.
“These new data demonstrate the potential for opicapone for use in a range of patients experiencing motor fluctuations, regardless of the point at which they occur.”
BIAL partnered with Neurocrine Biosciences in February 2017 to develop and commercialise opicapone in the US and Canada. Ongentys will be made available in the US this month.