Boston-based biotech Cerevance’s first-in-class Parkinson’s therapy, solengepras, has demonstrated its potential to improve both motor and non-motor symptoms in a late-stage study, potentially teeing the drug up for future regulatory submissions.
These positive results stem from the Phase III ARISE trial (NCT06553027), in which Cerevance pitted 75mg and 150mg daily doses of solengepras against placebo for 12 weeks in Parkinson’s patients who were having motor complications whilst taking symptom-managing medications like levodopa.
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During the study, a 150mg dose of solengepras reduced a patient’s average daily ‘off’ time, referring to a period when a patient’s motor symptoms return or worsen, by 0.61 hours from baseline over placebo – meeting the trial’s primary endpoint. Researchers observed solengepras’ impact on ‘off’ time as early as week two, and the drug maintained its effect throughout the 12-week study period.
On top of its impact on ‘off’ times, solengepras offered a significant 0.6-hour uptick in patient ‘on’ times, which describe the period in which a treated individual has adequate control over their symptoms. During this ‘on’ time, patients didn’t experience any troublesome issues with uncontrolled muscle movements, which are commonly associated with the long-term use of dopamine-based Parkinson’s symptom-managing therapies.
Researchers also found that solengepras could offer significant improvements in daily motor functioning, daytime sleepiness and general measures linked to a patient’s wellbeing, such as their mobility, emotional wellbeing and quality of life (QoL), over placebo.
Patients tolerated the drug well in this study, as nobody in the 150mg treatment group experienced a serious adverse event (AE). Discontinuation rates due to an AE were identical across all three treatment arms.
The positive outcomes of ARISE come in contrast to the readout from the Phase II ASCEND trial (NCT06006247) on solengepras, in which the drug failed to meet its primary endpoint of improvement in motor symptoms, despite showing benefits in non-motor symptoms such as sleep disturbances.
Cerevance mulls regulatory road forward for solengepras
With a late-stage win in the bag for solengepras, Cerevance now plans to engage with the US Food and Drug Administration (FDA) to determine its future steps for the drug as patients continue to face significant unmet needs.
“The positive ARISE results demonstrate the efficacy of solengepras as an adjunctive treatment in Parkinson’s disease patients with motor fluctuations on levodopa and other Parkinson’s disease medications,” commented GlobalData managing neurology analyst, Christie Wong.
“As a potential first-in-class agent, it differentiates itself from the dopaminergic mechanisms that dominate the Parkinson’s disease market,” she added.
However, Wong caveats that, if solengepras were to receive regulatory approval, its use would be confined to adjunctive treatment in Parkinson’s patients with motor fluctuations – limiting its use cases.
“Solengepras would offer an alternative for patients who prefer or require a non-dopaminergic mechanism,” she commented.
Despite this, solengepras’ Phase III success represents another win for the Parkinson’s community in recent times, as AbbVie previously secured a US approval for its next-generation dopamine-based therapy, Juvmo (tavapadon) – marking the end of an innovation dry spell within the indication.
According to a recent report from GlobalData, the parent company of Clinical Trials Arena, analysts expect the Parkinson’s disease space is expected to balloon at a compound annual growth rate (CAGR) of 7.9% to $7.2bn in 2033 across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) – a feat primarily driven by the anticipated launch of disease-modifying therapies (DMTs) and the expansion of recently approved symptomatic treatments.
