Cerevance Presents Topline Results from Phase 2 ASCEND Trial of Solengepras as Monotherapy Treatment for Early-Stage Parkinson’s Disease at AD/PD 2025
Cerevance has announced topline results from its Phase 2 ASCEND trial of solengepras, an investigational monotherapy for early-stage Parkinson's disease. The oral, non-dopaminergic therapy showed potential benefits in functional and non-motor symptoms versus placebo.
Key findings include:
- Small, non-statistically significant improvement in motor symptoms (MDS-UPDRS Parts II+III)
- Trends in improvement observed in patient-reported measures including MDS-UPDRS Part I (-1.38, p=0.12) and Part II (-0.4, p=0.62)
- 100% patient completion rate with no serious adverse events related to the treatment
- Fewer adverse events related to non-motor symptoms in the treatment arm compared to placebo
The company's pivotal Phase 3 ARISE trial evaluating solengepras as adjunctive therapy in Parkinson's disease is ongoing, with topline data expected in first half of 2026.
Cerevance ha annunciato i risultati preliminari del suo studio di Fase 2 ASCEND su solengepras, una monoterapia sperimentale per il morbo di Parkinson in fase iniziale. La terapia orale, non dopaminergica, ha mostrato potenziali benefici nei sintomi funzionali e non motori rispetto al placebo.
I risultati chiave includono:
- Un lieve miglioramento non statisticamente significativo nei sintomi motori (MDS-UPDRS Parti II+III)
- Tendenze di miglioramento osservate in misure riportate dai pazienti, inclusi MDS-UPDRS Parte I (-1.38, p=0.12) e Parte II (-0.4, p=0.62)
- Un tasso di completamento del 100% da parte dei pazienti senza eventi avversi gravi correlati al trattamento
- Un numero inferiore di eventi avversi legati ai sintomi non motori nel gruppo di trattamento rispetto al placebo
Lo studio pivotale di Fase 3 ARISE dell'azienda, che valuta solengepras come terapia aggiuntiva nel morbo di Parkinson, è attualmente in corso, con dati preliminari attesi nella prima metà del 2026.
Cerevance ha anunciado los resultados preliminares de su ensayo de Fase 2 ASCEND sobre solengepras, una monoterapia experimental para la enfermedad de Parkinson en etapas tempranas. La terapia oral, no dopaminérgica, mostró beneficios potenciales en los síntomas funcionales y no motores en comparación con el placebo.
Los hallazgos clave incluyen:
- Una pequeña mejora no estadísticamente significativa en los síntomas motores (MDS-UPDRS Partes II+III)
- Tendencias de mejora observadas en medidas reportadas por los pacientes, incluyendo MDS-UPDRS Parte I (-1.38, p=0.12) y Parte II (-0.4, p=0.62)
- Tasa de finalización del 100% por parte de los pacientes sin eventos adversos graves relacionados con el tratamiento
- Menos eventos adversos relacionados con síntomas no motores en el grupo de tratamiento en comparación con el placebo
El ensayo pivotal de Fase 3 ARISE de la compañía, que evalúa solengepras como terapia adjunta en la enfermedad de Parkinson, está en curso, con datos preliminares esperados en la primera mitad de 2026.
세레반스는 초기 단계 파킨슨병에 대한 실험적 단독 요법인 솔렌게프라스의 2상 ASCEND 시험에서 topline 결과를 발표했습니다. 이 경구 비도파민 요법은 위약에 비해 기능적 및 비운동 증상에서 잠재적인 이점을 보여주었습니다.
주요 발견 사항은 다음과 같습니다:
- 운동 증상에서의 작고 통계적으로 유의미하지 않은 개선 (MDS-UPDRS II+III 부분)
- MDS-UPDRS I 부분 (-1.38, p=0.12) 및 II 부분 (-0.4, p=0.62) 등 환자가 보고한 지표에서 관찰된 개선 경향
- 치료와 관련된 심각한 부작용 없이 100%의 환자 완료율
- 위약에 비해 치료군에서 비운동 증상과 관련된 부작용이 더 적음
파킨슨병에서 보조 요법으로서 솔렌게프라스를 평가하는 회사의 결정적인 3상 ARISE 시험이 진행 중이며, 2026년 상반기에 topline 데이터가 예상됩니다.
Cerevance a annoncé les résultats préliminaires de son essai de Phase 2 ASCEND sur solengepras, une monothérapie expérimentale pour la maladie de Parkinson à un stade précoce. La thérapie orale, non dopaminergique, a montré des bénéfices potentiels sur les symptômes fonctionnels et non moteurs par rapport au placebo.
Les résultats clés incluent:
- Une amélioration légère, non statistiquement significative, des symptômes moteurs (MDS-UPDRS Parties II+III)
- Tendances d'amélioration observées dans les mesures rapportées par les patients, y compris MDS-UPDRS Partie I (-1.38, p=0.12) et Partie II (-0.4, p=0.62)
- Taux de complétion de 100 % des patients sans événements indésirables graves liés au traitement
- Moins d'événements indésirables liés aux symptômes non moteurs dans le groupe traité par rapport au placebo
L'essai pivot de Phase 3 ARISE de l'entreprise, évaluant solengepras comme thérapie adjuvante dans la maladie de Parkinson, est en cours, avec des données préliminaires attendues au premier semestre 2026.
Cerevance hat die vorläufigen Ergebnisse seiner Phase-2-Studie ASCEND zu solengepras, einer experimentellen Monotherapie für die frühe Parkinson-Krankheit, bekannt gegeben. Die orale, nicht-dopaminergische Therapie zeigte potenzielle Vorteile bei funktionalen und nicht-motorischen Symptomen im Vergleich zum Placebo.
Wichtige Ergebnisse umfassen:
- Eine kleine, nicht statistisch signifikante Verbesserung der motorischen Symptome (MDS-UPDRS Teile II+III)
- Beobachtete Verbesserungstrends in von Patienten berichteten Messungen, einschließlich MDS-UPDRS Teil I (-1.38, p=0.12) und Teil II (-0.4, p=0.62)
- 100% Abschlussrate der Patienten ohne schwerwiegende unerwünschte Ereignisse im Zusammenhang mit der Behandlung
- Weniger unerwünschte Ereignisse im Zusammenhang mit nicht-motorischen Symptomen in der Behandlungsgruppe im Vergleich zur Placebo-Gruppe
Die entscheidende Phase-3-Studie ARISE des Unternehmens, die solengepras als Zusatztherapie bei Parkinson bewertet, ist im Gange, wobei die vorläufigen Daten in der ersten Hälfte des Jahres 2026 erwartet werden.
- 100% patient retention rate in Phase 2 trial
- No serious adverse events reported
- Fewer non-motor symptom adverse events vs placebo
- Demonstrated potential benefits in functional and non-motor symptoms
- Failed to achieve statistically significant improvement in primary endpoint
- No differentiation from placebo in Part III physician-administered neurological exam
- Small improvements in motor symptoms were not statistically significant
Insights
The ASCEND trial results for solengepras present a mixed picture that warrants careful interpretation. While the drug failed to achieve statistical significance on the primary endpoint (MDS-UPDRS Parts II+III), the consistent trends across multiple patient-reported measures suggest targeted benefits on functional impairments and non-motor symptoms—areas poorly addressed by current therapies.
Notably, the improvements in MDS-UPDRS Part I (-1.38, p=0.12) and Non-Motor Symptoms Scale (-1.7, p=0.59) align with solengepras's novel non-dopaminergic mechanism as a GPR6 inhibitor. The excellent safety profile—with 100% participant completion and fewer non-motor adverse events than placebo—represents a significant advantage over traditional dopaminergic therapies that frequently cause dyskinesia and other troublesome side effects.
The pivoting focus to adjunctive therapy in the ongoing Phase 3 ARISE trial appears strategically sound. As monotherapy, solengepras showed modest effects on motor symptoms but promising signals on functional and non-motor measures. In combination with established dopaminergic agents, it may offer complementary benefits addressing critical quality-of-life factors while maintaining an impressive safety profile. This positions solengepras uniquely in the treatment landscape—not as a replacement for levodopa, but as a targeted solution for persistent symptoms that dramatically impact daily functioning.
Cerevance's Phase 2 ASCEND results exemplify the inherent challenges of neurodegenerative disease drug development. The primary endpoint miss (non-significant improvement in MDS-UPDRS Parts II+III) represents a setback, but several factors provide context for evaluating solengepras's continued development potential.
The consistent signals across multiple patient-reported measures, while not statistically significant, suggest biological activity aligned with solengepras's mechanism. The exceptional safety profile—no serious adverse events and fewer non-motor symptom-related adverse events than placebo—creates a differentiating advantage over existing treatments.
Cerevance's strategic pipeline positioning remains intact. The ongoing Phase 3 ARISE trial wisely repositions solengepras as adjunctive therapy rather than monotherapy, potentially complementing standard treatments. This represents a more pragmatic path to regulatory approval and commercial adoption.
The company's explicit focus on functional and non-motor symptoms targets substantial unmet needs in Parkinson's management. Current dopaminergic therapies inadequately address these symptoms, which significantly impact quality of life. Cerevance appears committed to this differentiated approach despite the mixed Phase 2 results, suggesting internal confidence in solengepras's mechanistic rationale and commercial potential. The first half 2026 readout timeline for ARISE maintains a reasonable development pathway.
- Solengepras showed evidence of potential benefit in functional and non-motor symptoms versus placebo as measured by MDS-UPRDS Parts I, II, NMSS, and ESS, consistent with its novel non-dopaminergic mechanism of action
- This investigational treatment was generally well tolerated with no serious adverse events; fewer adverse events related to non-motor symptoms were reported in the solengepras arm
- Pivotal Phase 3 ARISE trial evaluating solengepras as adjunctive therapy in Parkinson’s disease is ongoing with topline data expected in first half of 2026
BOSTON, April 01, 2025 (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, today announced topline results from the Phase 2 ASCEND trial of solengepras as an investigational monotherapy in patients with early, untreated Parkinson’s disease. The data was presented today in the “Advances in PD” Symposium session at AD/PD™ 2025, the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, in Vienna.
Solengepras, the most advanced investigational treatment in Cerevance’s pipeline, is an oral, non-dopaminergic therapy in Phase 3 development 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. This novel mechanism of action is designed to reduce motor complications such as dyskinesia, minimize periods of symptomatic worsening (“OFF” time), and improve non-motor symptoms.
In the ASCEND trial, solengepras showed a small, 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. Those results were not statistically significant primarily because of the lack of differentiation between solengepras and placebo in the Part III physician-administered neurological exam, which assesses the physical signs of Parkinson’s disease at a single point in time.
Trends in improvement were observed for several other patient-reported measures. Those included the MDS-UPDRS Part I (-1.38, p=0.12), the MDS-UPDRS Part II (-0.4, p=0.62), the Non-Motor Symptoms Scale (-1.7, p=0.59), and the Epworth Sleepiness Scale (-0.3, p=0.62), indicating potential benefit in both functional and non-motor aspects of Parkinson’s disease.
Solengepras was well tolerated, with
"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," said Aaron L. Ellenbogen, D.O., M.P.H., primary investigator of the ASCEND trial, assistant professor of medicine at Oakland University William Beaumont School of Medicine, and neurologist at the Parkinson’s Disease & Movement Disorders Center at the Michigan Institute for Neurological Disorders. "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."
“We are encouraged by the results of the Phase 2 ASCEND trial of solengepras as a monotherapy, which align with findings from our Phase 2 trial of solengepras as an adjunctive therapy, with both demonstrating benefits on patient-reported measures,” said Craig Thompson, chief executive officer of Cerevance. “The ASCEND data further reinforces that solengepras, with its novel, non-dopaminergic mechanism, appears to be more effective in impacting the functional and non-motor symptoms captured by patient-reported outcomes, which are generally considered more meaningful for patients. Given the treatment gaps in addressing these symptoms, solengepras has the potential to fill a critical unmet need in Parkinson’s disease care.”
About the Phase 2 ASCEND Trial
The multicenter, randomized, double-blind, placebo-controlled Phase 2 ASCEND (A novel Selective Compound to ENable Individuals with Parkinson’s Disease) evaluated the efficacy and safety of solengepras in patients with early Parkinson’s disease who have not been treated with dopaminergic or anti-Parkinson’s therapies. A total of 64 patients age 30 and older were randomized to solengepras 150 mg daily or placebo for 12 weeks. The primary endpoint was change from baseline to week 12 on the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II+III. Key secondary endpoints included MDS-UPDRS Parts I-III, the Non-motor Symptoms Scale (NMSS), the Epworth Sleepiness Scale (ESS), and safety. ASCEND was conducted at sites in the United States.
About Solengepras (formerly 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 medication in the Phase 3 ARISE trial.
About the Pivotal Phase 3 ARISE Trial
The 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 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 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 Cerevance
Cerevance is focused on advancing cell type-specific therapies for the treatment of neurodegenerative, psychiatric, and central nervous system-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 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 therapy, CVN766, is designed to be a highly selective oral antagonist of the orexin 1 receptor for the potential treatment of binge eating disorder and schizophrenia. Our third 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 Simoes, ir@cerevance.com
Media
April Dovorany, adovorany@realchemistry.com, +1-262-909-8739
FAQ
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