CVN-424

Phase 2 results selected as one of only 10 featured presentations in the Poster Tour at the 2025 Parkinson Study Group (PSG) Annual MeetingPivotal Phase 3 ARISE trial evaluating solengepras as an adjunctive treatment in Parkinson’s disease is underway and actively enrolling patients BOSTON, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Cerevance, a clinical-stage biopharmaceutical company advancing targeted therapies for neurodegenerative diseases and obesity, today presented positive Phase 2 results of solengepras, a novel, non-dopaminergic GPR6 inhibitor in development as an adjunctive treatment for Parkinson’s disease. The findings demonstrated that four weeks of once-daily treatment with solengepras significantly reduced OFF time (periods of symptomatic worsening) by decreasing both the number and duration of OFF episodes, including morning OFF time. The data was presented today by Harini Sarva, M.D., trial investigator and associate professor of clinical neurology at Weill Cornell Medicine in New York, during the 2025 Parkinson Study Group (PSG) Annual Meeting in San Diego. The presentation was selected as one of only 10 featured posters in this year’s Poster Tour. “More than 90% of individuals with Parkinson’s disease who have received carbidopa/levodopa therapy for over 5 years experience motor fluctuations, including daily OFF time,” said Dr. Sarva. “These OFF episodes, which can cause a return of Parkinson’s motor symptoms, can be very disabling. The significant and clinically meaningful reductions in OFF time observed with solengepras highlight the potential of this once-daily, oral treatment to improve quality of life. Remarkably, the magnitude of benefit is clinically meaningful and may provide patients with a non-invasive alternative to other therapies." Phase 2 Results The randomized, double-blind Phase 2 study evaluated solengepras as an adjunctive treatment in adults with Parkinson’s disease experiencing motor fluctuations. Key findings include: Primary efficacy endpoint: Solengepras 150mg achieved a statistically significant 1.3-hour reduction in average daily OFF time versus placebo after 27 days of treatment (p=0.02).In a subgroup of patients with 3 or more hours of baseline OFF time (88% of study participants), a normalized regulatory analysis showed that solengepras 150 mg: Reduced OFF time by 1.78-hours versus placebo at Day 27 (p=0.0045).Improved total daily OFF time by 34.7% from baseline versus placebo (p=0.0026).Decreased the number of OFF periods per day by 0.98 episodes versus placebo (p=0.0026).Reduced the duration of each OFF period by 26 minutes versus placebo (p=0.0958). Solengepras was well tolerated, with a low incidence of dopaminergic adverse events. “Despite being the fastest-growing neurological disorder worldwide, Parkinson’s disease has seen limited therapeutic innovation in the past 25 years,” said Craig Thompson, chief executive officer of Cerevance. “These data reinforce solengepras’ potential as a differentiated, non-dopaminergic approach. With the Phase 3 ARISE trial now underway, we are one step closer to bringing this treatment option to patients in need.” Solengepras is being evaluated in the global, Phase 3 ARISE trial as a once-daily, oral treatment for use as an adjunctive therapy to levodopa and other anti-Parkinsonian medications. Topline data are expected in 2026. About Solengepras (CVN424)Solengepras is designed to provide a potentially novel approach to the treatment of Parkinson’s disease. Unlike dopaminergic therapies, which primarily act by replenishing, enhancing, or mimicking dopamine, solengepras is designed to selectively address the indirect pathway by modulating the GPR6 receptor. By inhibiting GPR6, solengepras aims to restore both motor and non-motor function without directly affecting dopamine levels or signaling, improving the relative balance between the direct and indirect pathways, and potentially reducing the risk of common side effects associated with dopaminergic therapies, such as dyskinesias and motor fluctuations. Solengepras is currently being evaluated as a once-daily, oral treatment for use as an adjunctive therapy to levodopa and other anti-Parkinsonian medications in the Phase 3 ARISE trial. About the Pivotal Phase 3 ARISE TrialThe multicenter, randomized, double-blind, placebo-controlled Phase 3 ARISE trial is evaluating the efficacy and safety of solengepras as an adjunctive therapy to levodopa and other background Parkinson’s disease medications. The trial is enrolling approximately 330 patients with Parkinson’s disease age 30 and older with motor fluctuations who have an average of three or more hours of total OFF time per day. Study participants are randomized to solengepras 75 mg or 150 mg or placebo once daily for 12 weeks. The primary endpoint is the change from baseline to week 12 in average daily OFF time for solengepras 150 mg versus placebo. Secondary objectives include assessing safety and tolerability and further characterizing the effect of solengepras on other motor symptoms (e.g., ON time), non-motor symptoms (e.g., daytime sleepiness), cognitive function, and several quality-of-life measures (e.g., Movement Disorder Society-UPDRS, PD Questionnaire 39, Clinical Global Impression scale, Patient Global Impression scale). ARISE is being conducted globally at sites in the United States and Europe. About Parkinson’s DiseaseParkinson’s disease is a progressive neurodegenerative disorder that is characterized by both motor symptoms, such as tremor, rigidity, and bradykinesia/akinesia, and non-motor symptoms, such as mood changes, apathy, and cognitive deficits. Globally, Parkinson’s disease is the fastest growing neurological disorder, affecting more than 10 million people worldwide and approximately 1 million people in the United States. The current standard of care has primarily relied on dopaminergic therapies, such as levodopa, which lose effectiveness over time and are associated with side effects that result in challenging risk-benefit profiles. About CerevanceCerevance is focused on advancing cell type-specific therapies for the treatment of neurodegenerative diseases and obesity. Our proprietary platform, Nuclear Enriched Transcript Sort sequencing (NETSseq), allows us to identify targets that are expressed at very low levels, that are present in rare cell types, or that change over time as a disease progresses. Our most advanced investigational treatment, solengepras, is currently in Phase 3 development and has the potential to be a first-in-class, oral non-dopaminergic therapy for both motor and non-motor symptoms of Parkinson's disease. Our second investigational treatment, CVN293, is a highly selective investigational oral inhibitor targeting potassium two pore domain channel subfamily K member 13 (KCNK13). CVN293 represents a potentially novel intervention point for neurodegenerative disorders and obesity. For more information, please visit www.cerevance.com and follow us on LinkedIn and X. Contacts Cerevance: Johnna Simões, ir@cerevance.com Media:April Dovorany, adovorany@realchemistry.com

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