Genentech’s Phase IIb Study of Prasinezumab Missed Primary Endpoint, but Suggests Possible Benefit in Early-Stage Parkinson’s Disease
Genentech 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 time to 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 with no new concerns.
The company will continue the Phase II PASADENA and Phase IIb PADOVA open-label extension studies while working with health authorities to determine future steps. Full results will be presented at an upcoming medical meeting.
Genentech ha annunciato i risultati del suo studio di Fase IIb PADOVA su prasinezumab in 586 pazienti con malattia di Parkinson in fase iniziale. Lo studio non ha raggiunto il suo obiettivo principale riguardante il tempo di progressione motoria confermata (HR=0.84, p=0.0657), sebbene abbia mostrato un potenziale effetto clinico. 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 in vari endpoint secondari ed esplorativi e ha mantenuto un profilo di sicurezza favorevole senza nuove preoccupazioni.
L'azienda continuerà gli studi di estensione open-label della Fase II PASADENA e della Fase IIb PADOVA, collaborando con le autorità sanitarie per determinare i prossimi passi. I risultati completi verranno presentati a un prossimo incontro medico.
Genentech anunció los resultados de su estudio de Fase IIb PADOVA sobre prasinezumab en 586 pacientes con enfermedad de Parkinson en etapas tempranas. El estudio no alcanzó su objetivo principal de tiempo hasta la progresión motora confirmada (HR=0.84, p=0.0657), aunque mostró un potencial de 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 en múltiples endpoints secundarios y exploratorios y mantuvo un perfil de seguridad favorable sin nuevas preocupaciones.
La compañía continuará los estudios de extensión open-label de la Fase II PASADENA y la Fase IIb PADOVA mientras trabaja con las autoridades de salud para determinar los próximos pasos. Los resultados completos se presentarán en una próxima reunión médica.
제넨텍은 586명의 초기 단계 파킨슨병 환자를 대상으로 한 프라시네주맙의 2b상 PADOVA 연구 결과를 발표했습니다. 이 연구는 확인된 운동 진행 시간의 주요 목표를 달성하지 못했지만(HR=0.84, p=0.0657), 잠재적인 임상 효능을 보여주었습니다. 사전 지정된 분석에 따르면 레보도파 치료를 받은 환자(참가자의 75%, HR=0.79)에서 더 강한 효과가 나타났습니다. 이 약물은 여러 보조 및 탐색적 기준에서 일관된 긍정적인 경향을 보여주었고 새로운 우려 사항 없이 긍정적인 안전성 프로파일을 유지했습니다.
회사는 향후 단계를 결정하기 위해 보건 당국과 협력하면서 2상 PASADENA 및 2b상 PADOVA 개방형 연장 연구를 계속 진행할 것입니다. 전체 결과는 다음 의학 회의에서 발표될 예정입니다.
Genentech 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 concernant le temps de progression motrice confirmée (HR=0,84, p=0,0657), bien qu'elle ait montré un potentiel d'efficacité clinique. Une analyse prédéfinie 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 dans plusieurs critères secondaires et exploratoires et a maintenu un profil de sécurité favorable, sans nouvelles préoccupations.
L'entreprise continuera les études d'extension en ouvert de la Phase II PASADENA et de la Phase IIb PADOVA tout en travaillant avec les autorités de santé pour déterminer les prochaines étapes. Les résultats complets seront présentés lors d'une prochaine réunion médicale.
Genentech hat die Ergebnisse seiner Phase-IIb-Studie PADOVA zu prasinezumab bei 586 Patienten mit frühzeitigem Parkinson veröffentlicht. Die Studie verfehlte ihren primären Endpunkt der Zeit bis zur bestätigten motorischen Progression (HR=0,84, p=0,0657), zeigte jedoch ein potenzielles klinisches Wirksamkeit. Eine vorab festgelegte Analyse ergab stärkere Effekte bei mit Levodopa behandelten Patienten (75 % der Teilnehmer, HR=0,79). Das Medikament zeigte durchweg positive Tendenzen in mehreren sekundären und explorativen Endpunkten und wies ein günstiges Sicherheitsprofil auf, ohne neue Bedenken.
Das Unternehmen wird die offenen Erweiterungsstudien der Phase II PASADENA und Phase IIb PADOVA fortsetzen und gleichzeitig mit den Gesundheitsbehörden zusammenarbeiten, um die nächsten Schritte zu bestimmen. Die vollständigen Ergebnisse werden auf einer bevorstehenden medizinischen Tagung präsentiert.
- Stronger efficacy observed in levodopa-treated patients (HR=0.79)
- Positive trends across multiple secondary endpoints
- Favorable safety profile with no new concerns
- Continuation of ongoing extension studies
- Missed primary endpoint (p=0.0657)
- Statistical significance not achieved in motor progression endpoint
–
– Prasinezumab continues to be well tolerated and no new safety signals were observed –
– Genentech is further evaluating the data and will work together with health authorities to determine next steps –
“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., 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
Full results from the
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
Roche/Genentech 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
The primary endpoint of
About Parkinson’s disease
Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disease characterized 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/Genentech 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 Genentech in Neuroscience
Neuroscience is a major focus of research and development at Genentech. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.
Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. 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 Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in
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Source: Genentech
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