Roche鈥檚 Phase IIb study of prasinezumab missed primary endpoint, but suggests possible benefit in early-stage Parkinson鈥檚 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 pi霉 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 autorit脿 sanitarie riguardo i prossimi passi. I risultati completi saranno presentati in un prossimo incontro medico.
Roche anunci贸 los resultados de su estudio de Fase IIb PADOVA de prasinezumab en 586 pacientes con enfermedad de Parkinson en etapa temprana. El estudio no alcanz贸 su objetivo primario de progresi贸n motora confirmada (HR=0.84, p=0.0657), aunque mostr贸 una potencial eficacia cl铆nica. Un an谩lisis predefinido revel贸 efectos m谩s fuertes en pacientes tratados con levodopa (75% de los participantes, HR=0.79). El f谩rmaco demostr贸 tendencias positivas consistentes a trav茅s de m煤ltiples puntos finales secundarios y exploratorios y mantuvo un perfil de seguridad favorable.
Los estudios de extensi贸n de Fase II PASADENA y IIb PADOVA continuar谩n mientras Roche eval煤a los datos y consulta con las autoridades sanitarias sobre los pr贸ximos pasos. Los resultados completos se presentar谩n en una pr贸xima reuni贸n m茅dica.
搿涤妶電� 586氇呾潣 齑堦赴 雼硠 韺岉偍鞀硲 頇橃瀽毳� 雽�靸侅溂搿� 頃� 顶勲澕鞁滊劋欤茧鞚� 2b靸� PADOVA 鞐瓣惮 瓴瓣臣毳� 氚滍憸頄堨姷雼堧嫟. 鞚� 鞐瓣惮電� 頇曥爼霅� 鞖措彊 歆勴枆鞚� 欤检殧 氇╉憸毳� 雼劚頃橃 氇豁枅鞀惦媹雼�(HR=0.84, p=0.0657), 攴鸽煬雮� 鞛犾灛鞝侅澑 鞛勳儊 須姤鞚� 氤挫棳欤检棃鞀惦媹雼�. 靷爠 歆�鞝曤悳 攵勳劃鞐愳劀電� 霠堧炒霃勴寣 旃橂毳� 氚涭潃 頇橃瀽(彀胳棳鞛愳潣 75%, HR=0.79)鞐愳劀 雿� 臧曧暅 須臣臧� 雮橅儉雮姷雼堧嫟. 鞚� 鞎诫鞚� 鞐煬 2彀� 氚� 韮愳儔鞝� 歆�鞝愳棎靹� 鞚缄磤霅橁矊 旮嶌爼鞝侅澑 瓴巾枼鞚� 氤挫榾鞙茧┌ 鞖办垬頃� 鞎堨爠靹� 頂勲頃勳潉 鞙犾頄堨姷雼堧嫟.
順勳灛 歆勴枆 欷戩澑 2靸� PASADENA 氚� 2b靸� PADOVA 鞓ろ攬 霛茧波 頇曥灔 鞐瓣惮電� 搿涤妶臧� 雿办澊韯半ゼ 韽夑皜頃橁碃 雼れ潓 雼硠鞐� 雽�頃� 氤搓贝 雼龟淡瓿� 靸侂嫶頃橂姅 霃欖晥 瓿勳啀霅� 瓴冹瀰雼堧嫟. 鞝勳泊 瓴瓣臣電� 雼り皜鞓る姅 鞚橅暀 須岇潣鞐愳劀 氚滍憸霅� 鞓堨爼鞛呺媹雼�.
Roche a annonc茅 les r茅sultats de son 茅tude de Phase IIb PADOVA sur prasinezumab aupr猫s de 586 patients atteints de la maladie de Parkinson 脿 un stade pr茅coce. L'茅tude n'a pas atteint son objectif principal de progression motrice confirm茅e (HR=0,84, p=0,0657), bien qu'elle ait montr茅 un potentiel d'efficacit茅 clinique. Une analyse pr茅sp茅cifi茅e a r茅v茅l茅 des effets plus forts chez les patients trait茅s par l茅vodopa (75 % des participants, HR=0,79). Le m茅dicament a montr茅 des tendances positives constantes 脿 travers plusieurs crit猫res secondaires et exploratoires et a maintenu un profil de s茅curit茅 favorable.
Les 茅tudes d'extension ouvertes de Phase II PASADENA et IIb PADOVA se poursuivront pendant que Roche 茅value les donn茅es et consulte les autorit茅s sanitaires sur les prochaines 茅tapes. Les r茅sultats complets seront pr茅sent茅s lors d'une prochaine r茅union m茅dicale.
Roche hat die Ergebnisse der Phase IIb PADOVA-Studie zu Prasinezumab bei 586 Patienten mit fr眉hstadialer Parkinson-Krankheit bekannt gegeben. Die Studie verfehlte ihr prim盲res Ziel der best盲tigten motorischen Progression (HR=0,84, p=0,0657), zeigte jedoch ein potenzielles klinisches Potenzial. Eine vordefinierte Analyse ergab st盲rkere Effekte bei mit Levodopa behandelten Patienten (75 % der Teilnehmer, HR=0,79). Das Medikament zeigte durchgehend positive Tendenzen in mehreren sekund盲ren und explorativen Endpunkten und wies ein g眉nstiges Sicherheitsprofil auf.
Die laufenden Phase-II PASADENA- und Phase-IIb PADOVA-Studien zur offenen Verl盲ngerung werden fortgesetzt, w盲hrend Roche die Daten auswertet und sich mit den Gesundheitsbeh枚rden 眉ber die n盲chsten Schritte beraten l盲sst. Vollst盲ndige Ergebnisse werden auf einer bevorstehenden medizinischen Konferenz pr盲sentiert.
- 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鈥檚 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 (
鈥淧arkinson鈥檚 is complex and devastating with no disease modifying treatment options available for the millions of people impacted,鈥� said Levi Garraway, M.D., Ph.D., Roche鈥檚 Chief Medical Officer and Head of Global Product Development. 鈥淲e believe the consistent efficacy trends from the Phase IIb study of prasinezumab merit further exploration. We will continue our close collaboration with the Parkinson鈥檚 community as we further evaluate the data to determine next steps.鈥�
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 伪-syn and reduce neuronal toxicity. By targeting the build-up of 伪-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 伪-syn aggregates as a mechanism of action in Parkinson鈥檚 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鈥�=鈥�94) and early-start (n鈥�=鈥�177) groups showed a slower decline (a smaller increase in score) in MDS鈥揢PDRS Part鈥塈II scores in the OFF state (delayed start, 鈭�
Roche entered into a Licensing, Development, and Commercialisation agreement with Prothena in December 2013 to develop and commercialise monoclonal antibodies targeting 伪-syn, such as prasinezumab, for the treatment of Parkinson鈥檚 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鈥檚 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鈥檚 disease (鈮�5-point increase in Movement Disorder Society-Unified Parkinson鈥檚 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鈥檚 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鈥檚 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鈥檚 quality of life; however, no available symptomatic therapies slow down or stop the clinical progression of Parkinson鈥檚 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鈥檚 disease that involve targeting underlying disease processes such as aggregated 伪-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鈥檚 disease, Parkinson鈥檚 disease and Huntington鈥檚 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鈥檚 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鈥檚 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.
For more information, please visit .
All trademarks used or mentioned in this release are protected by law.
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
| Hans Trees, PhD Phone: +41 79 407 72 58 | Sileia Urech Phone: +41 79 935 81 48 听 |
| Nathalie Altermatt Phone: +41 79 771 05 25 | Lorena Corfas Phone: +41 79 568 24 95 听 |
| Simon Goldsborough Phone: +44 797 32 72 915 | Karsten Kleine Phone: +41 79 461 86 83 听 |
| Nina M盲hlitz Phone: +41 79 327 54 74 | Kirti Pandey Phone: +49 172 6367262 听 |
| Yvette Petillon Phone: +41 79 961 92 50 | Dr Rebekka Schnell Phone: +41 79 205 27 03 |
Roche Investor Relations
| Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com | Dr Sabine Borngr盲ber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com 听 |
| Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com | 听 |
Investor Relations North America
| Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com | 听 |
Attachment
FAQ
What were the results of Roche's (RHHBY) Phase IIb PADOVA study for prasinezumab?
How did prasinezumab perform in levodopa-treated Parkinson's patients (RHHBY)?
What is the safety profile of Roche's (RHHBY) prasinezumab in Parkinson's disease?
What are the next steps for Roche's (RHHBY) prasinezumab development?
