The company will continue with the Phase III trial despite the Phase II failure. Image credit: Shutterstock / R Photography Background.
US-based biotech Cerevance is continuing an ongoing pivotal study of its Parkinson’s disease candidate despite it showing no benefit compared to placebo in a Phase II study.
The biotech announced data from the Phase II ASCEND trial of solengepras at AD/PD 2025, the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, in Vienna.
In the Phase II trial (NCT06006247), solengepras showed a non-statistically significant improvement in Parkinson’s disease motor symptoms from baseline to week 12 compared to placebo as assessed by the combined Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II+III.
The biotech said the data is not statistically significant primarily because of the lack of differentiation between solengepras and a placebo in the Part III physician-administered neurological exam.
The study noted improvements for several other patient-reported measures including a 1.38-point reduction in MDS-UPDRS Part I, a 0.4-point reduction in the MDS-UPDRS Part II, a 1.7-point reduction in the Non-Motor Symptoms Scale, and a 0.3-point reduction in the Epworth Sleepiness Scale, indicating potential benefit in both functional and non-motor aspects of Parkinson’s disease.
Solengepras was well tolerated, with 100% of patients in the treatment arm completing the 12-week trial and no discontinuations due to drug-related adverse events (AE). No serious AEs related to solengepras were reported.
Primary investigator and assistant professor of medicine at Oakland University William Beaumont School of Medicine, Dr Aaron Ellenbogen said: “For people with Parkinson’s disease, dopaminergic therapies are the standard of care as they reduce tremors, stiffness, slowed movement, and other symptoms.
“However, there are crucial treatment gaps in addressing functional impairments and non-motor symptoms. The improvements in functional and non-motor symptoms observed in the patient-reported measures of the ASCEND trial suggest that solengepras could be a promising option for managing non-motor symptoms without the distressing side effects associated with conventional dopaminergic therapies.”
The ASCEND trial enrolled 62 patients with early untreated Parkinson’s disease across 42 sites in the US, evaluating solengepras as a monotherapy. It was also investigated as an adjunctive therapy with levodopa in another Phase II trial (NCT04191577) where it met the key efficacy endpoint and demonstrated a reduction in average daily “OFF” time at day 27. OFF time refers to periods when patients experience a worsening of their motor symptoms despite being on medication.
Solengepras is an oral, non-dopaminergic therapy for Parkinson’s disease. A brain-penetrant, specific inhibitor of GPR6, solengepras is designed to selectively target and modulate the specific brain circuits responsible for controlling motor and non-motor functions without directly affecting dopaminergic pathways.
Despite the Phase II failure, Cerevance is continuing to investigate the Parkinson’s disease therapy in the Phase III ARISE study (NCT06553027). the primary endpoint of which will evaluate the change in average daily OFF time on motor diaries compared to placebo.
According to GlobalData, the Parkinson’s disease market in the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) will grow to be worth approximately $7.9bn by 2033.
GlobalData is the parent company of Clinical Trials Arena.
Email newsletter icon
Sign up for our daily news round-up!
Give your business an edge with our leading industry insights.