Roche’s Phase IIb study of prasinezumab missed primary endpoint, but suggests possible benefit in early-stage Parkinson’s disease
Roche announced results from its Phase IIb PADOVA study of prasinezumab in 586 early-stage Parkinson's disease patients. The study missed its primary endpoint of confirmed motor progression (HR=0.84, p=0.0657), though showing potential clinical efficacy. A pre-specified analysis revealed stronger effects in levodopa-treated patients (75% of participants, HR=0.79). The drug demonstrated consistent positive trends across multiple secondary and exploratory endpoints and maintained a favorable safety profile.
The ongoing Phase II PASADENA and Phase IIb PADOVA open-label extension studies will continue while Roche evaluates the data and consults with health authorities about next steps. Full results will be presented at an upcoming medical meeting.
Roche ha annunciato i risultati del suo studio di Fase IIb PADOVA su prasinezumab in 586 pazienti con morbo di Parkinson in fase iniziale. Lo studio non ha raggiunto il suo obiettivo primario di progressione motoria confermata (HR=0.84, p=0.0657), anche se ha mostrato una potenziale efficacia clinica. Un'analisi predefinita ha rivelato effetti più forti nei pazienti trattati con levodopa (75% dei partecipanti, HR=0.79). Il farmaco ha dimostrato tendenze positive costanti attraverso diversi endpoint secondari ed esplorativi e ha mantenuto un profilo di sicurezza favorevole.
Gli studi di estensione a etichetta aperta di Fase II PASADENA e IIb PADOVA continueranno mentre Roche valuta i dati e consulta le autorità sanitarie riguardo i prossimi passi. I risultati completi saranno presentati in un prossimo incontro medico.
Roche anunció los resultados de su estudio de Fase IIb PADOVA de prasinezumab en 586 pacientes con enfermedad de Parkinson en etapa temprana. El estudio no alcanzó su objetivo primario de progresión motora confirmada (HR=0.84, p=0.0657), aunque mostró una potencial eficacia clínica. Un análisis predefinido reveló efectos más fuertes en pacientes tratados con levodopa (75% de los participantes, HR=0.79). El fármaco demostró tendencias positivas consistentes a través de múltiples puntos finales secundarios y exploratorios y mantuvo un perfil de seguridad favorable.
Los estudios de extensión de Fase II PASADENA y IIb PADOVA continuarán mientras Roche evalúa los datos y consulta con las autoridades sanitarias sobre los próximos pasos. Los resultados completos se presentarán en una próxima reunión médica.
로슈는 586명의 초기 단계 파킨슨병 환자를 대상으로 한 프라시네주맙의 2b상 PADOVA 연구 결과를 발표했습니다. 이 연구는 확정된 운동 진행의 주요 목표를 달성하지 못했습니다(HR=0.84, p=0.0657), 그러나 잠재적인 임상 효능을 보여주었습니다. 사전 지정된 분석에서는 레보도파 치료를 받은 환자(참여자의 75%, HR=0.79)에서 더 강한 효과가 나타났습니다. 이 약물은 여러 2차 및 탐색적 지점에서 일관되게 긍정적인 경향을 보였으며 우수한 안전성 프로필을 유지했습니다.
현재 진행 중인 2상 PASADENA 및 2b상 PADOVA 오픈 라벨 확장 연구는 로슈가 데이터를 평가하고 다음 단계에 대해 보건 당국과 상담하는 동안 계속될 것입니다. 전체 결과는 다가오는 의학 회의에서 발표될 예정입니다.
Roche a annoncé les résultats de son étude de Phase IIb PADOVA sur prasinezumab auprès de 586 patients atteints de la maladie de Parkinson à un stade précoce. L'étude n'a pas atteint son objectif principal de progression motrice confirmée (HR=0,84, p=0,0657), bien qu'elle ait montré un potentiel d'efficacité clinique. Une analyse préspécifiée a révélé des effets plus forts chez les patients traités par lévodopa (75 % des participants, HR=0,79). Le médicament a montré des tendances positives constantes à travers plusieurs critères secondaires et exploratoires et a maintenu un profil de sécurité favorable.
Les études d'extension ouvertes de Phase II PASADENA et IIb PADOVA se poursuivront pendant que Roche évalue les données et consulte les autorités sanitaires sur les prochaines étapes. Les résultats complets seront présentés lors d'une prochaine réunion médicale.
Roche hat die Ergebnisse der Phase IIb PADOVA-Studie zu Prasinezumab bei 586 Patienten mit frühstadialer Parkinson-Krankheit bekannt gegeben. Die Studie verfehlte ihr primäres Ziel der bestätigten motorischen Progression (HR=0,84, p=0,0657), zeigte jedoch ein potenzielles klinisches Potenzial. Eine vordefinierte Analyse ergab stärkere Effekte bei mit Levodopa behandelten Patienten (75 % der Teilnehmer, HR=0,79). Das Medikament zeigte durchgehend positive Tendenzen in mehreren sekundären und explorativen Endpunkten und wies ein günstiges Sicherheitsprofil auf.
Die laufenden Phase-II PASADENA- und Phase-IIb PADOVA-Studien zur offenen Verlängerung werden fortgesetzt, während Roche die Daten auswertet und sich mit den Gesundheitsbehörden über die nächsten Schritte beraten lässt. Vollständige Ergebnisse werden auf einer bevorstehenden medizinischen Konferenz präsentiert.
- Stronger efficacy observed in levodopa-treated patients (HR=0.79)
- Positive trends across multiple secondary endpoints
- Favorable safety profile with no new safety concerns
- Potential clinical benefit shown despite missing primary endpoint
- Failed to meet primary endpoint of motor progression (p=0.0657)
- Uncertainty about drug's future development path
- efficacy in non-levodopa treated patients
- PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints
- Prasinezumab continues to be well tolerated and no new safety signals were observed
- Roche is further evaluating the data and will work together with health authorities to determine next steps
Basel, 19 December 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from the Phase IIb PADOVA study investigating prasinezumab in 586 people with early-stage Parkinson’s disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01] and p=0.0657, missing statistical significance. In a pre-specified analysis, the effect of prasinezumab was more pronounced in the population treated with levodopa (
“Parkinson’s is complex and devastating with no disease modifying treatment options available for the millions of people impacted,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We believe the consistent efficacy trends from the Phase IIb study of prasinezumab merit further exploration. We will continue our close collaboration with the Parkinson’s community as we further evaluate the data to determine next steps.”
The Phase II PASADENA and Phase IIb PADOVA open-label extension studies will continue in order to explore the observed effects in both studies. Roche will continue to evaluate the data and work together with health authorities to determine next steps.
Full results from the PADOVA study will be presented at an upcoming medical meeting.
About prasinezumab
Prasinezumab is an investigational monoclonal antibody designed to selectively bind aggregated α-syn and reduce neuronal toxicity. By targeting the build-up of α-syn protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, thereby slowing down the progression of the disease. The evidence supporting targeting α-syn aggregates as a mechanism of action in Parkinson’s disease is based on a wide range of scientific evidence in the field.
Prasinezumab is currently being assessed in ongoing open-label extensions of the Phase II PASADENA and Phase IIb PADOVA studies. Four-year data from the PASADENA study showed potential evidence of sustained slowing of motor progression compared to a matched PPMI natural history study cohort, published in the October 2024 edition of Nature Medicine. The PASADENA delayed-start (n = 94) and early-start (n = 177) groups showed a slower decline (a smaller increase in score) in MDS–UPDRS Part III scores in the OFF state (delayed start, −
Roche entered into a Licensing, Development, and Commercialisation agreement with Prothena in December 2013 to develop and commercialise monoclonal antibodies targeting α-syn, such as prasinezumab, for the treatment of Parkinson’s disease.
About the PADOVA study
PADOVA is a Phase IIb multicentre, randomised, double-blind trial evaluating the efficacy and safety of prasinezumab compared with placebo in 586 randomised patients with early-stage Parkinson’s disease who were on stable symptomatic treatment (stable doses of levodopa or monoamine oxidase-B inhibitor as monotherapy for more than three months at baseline). Patients receive monthly intravenous doses of prasinezumab 1500 mg or placebo every four weeks for at least 76 weeks. This is followed by a two-year open-label extension phase in which all participants receive active treatment, which is currently ongoing.
The primary endpoint of PADOVA is the time to confirmed motor progression of Parkinson’s disease (≥5-point increase in Movement Disorder Society-Unified Parkinson’s Disease Rating Scale [MDS-UPDRS] Part III score assessed in OFF medication state). A 5-point increase in MDS-UPDRS Part III represents a clinically meaningful motor progression event (Trundell et al., in press).
About Parkinson’s disease
Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disease characterised by the gradual loss of neurons that make dopamine and other nerve cells, and the development of motor and non-motor symptoms that may appear years before diagnosis. Today, PD affects over 10 million people worldwide. The prevalence of Parkinson’s disease is increasing, and it has become one of the fastest-growing neurological disorders. Currently, symptomatic treatments that effectively alleviate motor symptoms are available today, having a significant impact on people’s quality of life; however, no available symptomatic therapies slow down or stop the clinical progression of Parkinson’s disease and the effects wear off over time as the disease progresses.
Roche is evaluating multiple approaches to slow down disease progression and potentially prevent Parkinson’s disease that involve targeting underlying disease processes such as aggregated α-syn production, lysosomal dysfunction and neuroinflammation.
About Roche in Neuroscience
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.
Roche is investigating more than a dozen medicines for neurological disorders, including neuromuscular diseases: Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy and spinal muscular atrophy; neuro immune diseases: multiple sclerosis and neuromyelitis optica spectrum disorder; and neurodegenerative diseases: Alzheimer’s disease, Parkinson’s disease and Huntington’s disease. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
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