BOSTON, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Cerevance, a clinical-stage biopharmaceutical company advancing multiple cell type-specific therapies for the treatment of neurodegenerative, psychiatric, and central nervous system-controlled metabolic disorders, has published the full results from the Phase 2 clinical trial of solengepras, in eClinicalMedicine, a peer-reviewed journal published by The Lancet Discovery Science Suite. The results demonstrated that solengepras, a potentially first-in-class, oral, once-daily, non-dopaminergic, GPR6 inverse agonist, significantly reduced OFF time in individuals with Parkinson's disease and was generally well-tolerated.
The Phase 2 clinical trial met the key efficacy endpoint and demonstrated a reduction in average daily OFF time from baseline at Day 27, as recorded over two days using a self-reported patient motor diary.
On Day 27, the change from baseline in daily OFF time was -1.6 hours (p <0.0001) in the solengepras 150 mg group, -1.3 hours (p <0.01) in the solengepras 50 mg group, and -0.5 hours in the placebo group. The placebo-adjusted least squares mean treatment difference was statistically significant for the solengepras 150 mg dose at -1.3 hours (p=0.0225).Decreases in OFF time were accompanied by trends towards increased total daily ON time without troublesome dyskinesia (Good ON time). The placebo-adjusted least squares mean treatment difference for good ON time was +0.67 (p=0.27) with the solengepras 150 mg dose.
In the supplementary post-hoc analysis, which applied the typical regulatory standardized analysis and evaluated patients with ≥3 hours of OFF time at baseline, the findings of the primary analysis were confirmed and additional improvement observed.
In the supplementary post-hoc analysis, treatment with solengepras 150 mg group reduced OFF time by -1.78 hours (p= 0.0045) compared to placebo and increased good ON time by +1.3 hours (p=0.04).
Favorable trends were observed for solengepras on key secondary endpoints that are encouraging considering the relatively short time frame of dosing with solengepras.
At Day 15, participants in the solengepras 150 mg group demonstrated a significantly improved ESS score of -1.35±0.68 compared to placebo (p=0.049).
Solengepras was generally well tolerated, and no serious treatment-related adverse events were reported.
The most common treatment-emergent adverse events (>5%) were headache and nausea which were generally mild and transient.
"We are excited to share the results of this important Phase 2 study with the broader scientific community through this publication in eClinicalMedicine," said chief executive officer, Craig Thompson. "The data demonstrated solengepras' potential to be a meaningful therapeutic option for individuals with Parkinson's disease, addressing not only motor symptoms but also overall quality-of-life."
For more information on the Phase 2 clinical trial and to access the full publication, visit https://www.sciencedirect.com/science/article/pii/S2589537024004619.
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 both a monotherapy (Phase 2 ASCEND clinical trial) and as an adjunctive therapy to levodopa and other anti-Parkinsonian medication (Phase 3 ARISE clinical trial).
About Parkinson's Disease
Parkinson'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 disorders, affecting more than ten million people worldwide and approximately one million people in the United States. The current standard of care has primarily relied on dopaminergic therapies, which lose effectiveness over time and are associated with side effects that result in challenging risk-benefit profiles.
About Cerevance
Cerevance is focused on advancing cell type-specific therapies for the treatment of neurodegenerative, psychiatric and central nervous system ("CNS")-controlled metabolic disorders. 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 product candidate, solengepras (CVN424), is currently in Phase 3 development and has the potential to be a first-in-class, oral non-dopaminergic therapy for both the motor and non-motor symptoms of Parkinson's disease. Our second product candidate, CVN766, is designed to be a highly selective oral antagonist of the orexin 1 receptor that we plan to evaluate in a Phase 2 study for the potential treatment of binge eating disorder and schizophrenia. Our third product candidate, CVN293, is a highly selective investigational oral inhibitor targeting potassium two pore domain channel subfamily K member 13 (KCNK13) and represents a potentially novel intervention point for neurodegenerative disorders by reducing neuroinflammation. We plan to evaluate CVN293 in a Phase 2 study for the potential treatment of frontotemporal dementia.
Contacts
Cerevance:
Johnna Simões, [email protected]
Media:
Andrew Mielach, [email protected], +1-646-876-5868
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