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- ||||| prasinezumab (RG7935) / Roche
Clinical: Thoughts on Prasinezumab's "mechanism targeting α-synuclein yet to be proven and some opinion leaders expressed doubts over likelihood of success with uncertainty whether targeting extracellular α-synuclein protein will offer enough benefits to patients." https://t.co/Eig8nqFn5x (Twitter) - Oct 15, 2021
- ||| prasinezumab (RG7935) / Roche
Gennero Pagano, MD, MSc, PhD, expert medical director, @Roche, provided thoughts on the investigational agent prasinezumab, overall Parkinson drug development, and MDS Virtual Congress. https://t.co/ZAQy5bCZhz (Twitter) - Oct 11, 2021
- prasinezumab (RG7935) / Roche
[VIRTUAL] Delayed-start analysis of PASADENA: A randomized Phase II study to evaluate the safety and efficacy of prasinezumab in early Parkinson’s disease; Part 2 Week 104 results () - Sep 29, 2021 - Abstract #MDSCongress2021MDS_Congress_1325;
P2, P2b
Further studies are needed to investigate these findings. The Phase IIb PADOVA (NCT04777331) study will assess the efficacy and safety of prasinezumab in people with early PD on stable symptomatic treatment.
- prasinezumab (RG7935) / Roche
[VIRTUAL] Prasinezumab reduced progression of Parkinson's disease motor features measured by Roche PD Mobile Application v2 sensor features: PASADENA Phase II Part 1 () - Sep 29, 2021 - Abstract #MDSCongress2021MDS_Congress_728;
P2
The Phase IIb PADOVA (NCT04777331) study will assess the efficacy and safety of prasinezumab in people with early PD on stable symptomatic treatment. The Roche PD Mobile Application v2 demonstrated decreased one-year progression of bradykinesia in prasinezumab vs. placebo treated individuals with early PD, consistent with a disease-modifying effect of prasinezumab.
- ABBV-0805 / BioArctic, AbbVie
[VIRTUAL] Evaluating Engagement of ABBV-0805, an Anti-Alpha-Synuclein Monoclonal Antibody to Physiological and Pathological Forms of Alpha-Synuclein for Phase 2 Dose Selection: A PBPK Modeling and Simulation Approach () - Sep 29, 2021 - Abstract #MDSCongress2021MDS_Congress_680;
The Roche PD Mobile Application v2 demonstrated decreased one-year progression of bradykinesia in prasinezumab vs. placebo treated individuals with early PD, consistent with a disease-modifying effect of prasinezumab. This PBPK/PD modeling approach was used to identify monthly intravenous Phase 2 doses of ABBV-0805 to maintain ≥ 95% oligomeric α-synuclein binding in CSF at steady state in PD patients.
- |||| prasinezumab (RG7935) / Roche
A great 10-part thread by @andrea_sturchio on the importance of soluble α-synuclein levels and why lowering them in #Parkinsons, such as with Prasinezumab/PRX002, is misguided. (Twitter) - Sep 4, 2021
- prasinezumab (RG7935) / Roche
[VIRTUAL] Phase II PASADENA Part one Week 52 results: Evaluating safety and efficacy of prasinezumab in early Parkinson’s disease (Room Vienna) - May 30, 2021 - Abstract #EAN2021EAN_1298;
P2
This PBPK/PD modeling approach was used to identify monthly intravenous Phase 2 doses of ABBV-0805 to maintain ≥ 95% oligomeric α-synuclein binding in CSF at steady state in PD patients. Prasinezumab had a favourable safety profile and is the first anti-alpha-synuclein antibody showing efficacy signals on clinical progression of PD motor features, warranting further study.
- prasinezumab (RG7935) / Roche
[VIRTUAL] Parkinson’s disease Mobile Application v2 detects potential disease modifying effect of prasinezumab (Room Vienna) - May 30, 2021 - Abstract #EAN2021EAN_1296;
P2
Prasinezumab had a favourable safety profile and is the first anti-alpha-synuclein antibody showing efficacy signals on clinical progression of PD motor features, warranting further study. In individuals with PD treated with prasinezumab, daily quantification of motor severity via a DHTT showed a divergence of slopes, which is consistent with an effect of disease progression.
- |||| prasinezumab (RG7935) / Roche
Enrollment open: PADOVA: A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease (clinicaltrials.gov) - Apr 1, 2021
P2b, N=575, Recruiting, Sponsor: Hoffmann-La Roche
In individuals with PD treated with prasinezumab, daily quantification of motor severity via a DHTT showed a divergence of slopes, which is consistent with an effect of disease progression. Not yet recruiting --> Recruiting
- prasinezumab (RG7935) / Roche
[VIRTUAL] Lessons Learned From Clinical Trials Targeting Alpha-Synuclein to Design Next-Generation Clinical Trials (Track B) - Mar 4, 2021 - Abstract #CNSS2021CNSS_10;
Synopsis How the results of the Phase 2 PASADENA study of Prasinezumab, a humanized monoclonal antibody for Parkinson’s disease, can inform future clinical trials How to apply a precision medicine approach in Parkinson’s disease clinical trials? Can we predict cognitive decline in Parkinson’s Disease to design studies evaluating this endpoint (lesson learned from PRECODE studies)?
- |||||| prasinezumab (RG7935) / Roche
New P2b trial: PADOVA: A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease (clinicaltrials.gov) - Mar 1, 2021
P2b, N=575, Not yet recruiting, Sponsor: Hoffmann-La Roche
- | prasinezumab (RG7935) / Roche
Prasinezumab - yes (Twitter) - Feb 25, 2021
- | prasinezumab (RG7935) / Roche
Is this about PRX002? (Twitter) - Feb 25, 2021
- ||||| prasinezumab (RG7935) / Roche
Clinical: Hope remains that Roche’s prasinezumab can overcome recent string of failures in #Parkinson’s disease https://t.co/LdhylOCRS3 via @Clinical Trials Arena (Twitter) - Feb 22, 2021
- cinpanemab (BIIB054) / Biogen, prasinezumab (RG7935) / Roche, PD03A / AFFiRiS
[VIRTUAL] ACTIVE AND PASSIVE IMMUNIZATION IN THE TREATMENT OF PARKINSON’S DISEASE (On Demand Symposia A) - Dec 24, 2020 - Abstract #ADPD2021ADPD_222;
To obtain active immunization AFFITOPE PD01A/PD03A has been tested in patients and healthy controls...Passsive immunization has been tested using two human antibodies PRX002/RG7935, and BIIB054...BIIB054 is actually in phase IIb since 18 months, no significant side effects have been reported during the double blind phase and interim results on clinical end-points are expected. Two other studies are starting one with UCB compound and another study with PRX.
- prasinezumab (RG7935) / Roche
[VIRTUAL] ROCHE PD MOBILE APPLICATION V2 DETECTS SLOWING OF EARLY PARKINSON’S DISEASE PROGRESSION UNDER PRASINEZUMAB: PASADENA PHASE 2 PART 1 RESULTS (On Demand Symposia A) - Dec 24, 2020 - Abstract #ADPD2021ADPD_219;
P2
Two other studies are starting one with UCB compound and another study with PRX. Daily quantification of motor severity via a DHTT in early-stage PD demonstrated a divergence of slopes in bradykinesia progression, consistent with a disease-modifying effect of prasinezumab.
- prasinezumab (RG7935) / Roche
[VIRTUAL] A PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PRASINEZUMAB IN EARLY PARKINSON'S DISEASE (PASADENA): RESULTS FROM PART 1 WEEK–52 (On Demand Symposia A) - Dec 24, 2020 - Abstract #ADPD2021ADPD_218;
Conclusions Prasinezumab had a favourable safety profile and is the first potentially disease-modifying, anti-α-synuclein antibody to show efficacy signals on clinical progression of core motor features of PD. Further studies are warranted.
- ||||| prasinezumab (RG7935) / Roche
Clinical: Roche and Prothena will Advance Prasinezumab into Late-Stage Clinical Development Study in #Parkinson’s Disease https://t.co/8aUro41kRZ (Twitter) - Oct 21, 2020
- prasinezumab (RG7935) / Roche
[VIRTUAL] PASADENA: A Phase 2 study to evaluate the safety and efficacy of prasinezumab in early Parkinson’s disease; Part 1 Week-52 results () - Sep 20, 2020 - Abstract #MDSCongress2020MDS Congress_967;
P2
PASADENA Part 1 did not reach the primary endpoint but prasinezumab showed a favorable safety profile and signal of efficacy on MDS-UPDRS Part III. PASADENA Part 2, a 52-week blinded extension assessing effects of prasinezumab on disease progression, is ongoing.
- || prasinezumab (RG7935) / Roche
Trial completion date: PASADENA: A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (clinicaltrials.gov) - May 22, 2020
P2, N=316, Active, not recruiting, Sponsor: Hoffmann-La Roche
PASADENA Part 2, a 52-week blinded extension assessing effects of prasinezumab on disease progression, is ongoing. Trial completion date: Feb 2021 --> Apr 2026
- |||| prasinezumab (RG7935) / Roche
Clinical: #Prasinezumab an antibody designed to eliminate clumps of #alphasynuclein in people w/ #PD, didn't lessen progression of motor & #NMS in a Ph II CT. @Roche in collab w/ #Prothena stated it showed signs of efficacy on multiple 2ndary & exploratory measures: https://t.co/HDkHGdOKCj (Twitter) - Apr 29, 2020
- ||| prasinezumab (RG7935) / Roche
We are in this for the long haul. Update on Phase 2 PASADENA study of prasinezumab (PRX002/RG7935) in #Parkinson's Disease https://t.co/3ZT82sDm0I (Twitter) - Apr 22, 2020
- ||| prasinezumab (RG7935) / Roche
Baseline Data from Phase 2 PASADENA Study of Prasinezumab (PRX002/RG7935) in #Parkinson’s Disease ... https://t.co/CkOGO9T5ch via @YahooFinance (Twitter) - Apr 1, 2020
- prasinezumab (RG7935) / Roche
[VIRTUAL] PASSIVE MONITORED DAILY MOTOR BEHAVIOR USING SMARTPHONES AND WEARABLE SENSORS IS SIGNIFICANTLY RELATED TO QUALITY OF LIFE IN PARKINSON’S DISEASE (EXHIBITION HALL) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_685;
Methods Data from 248 recently diagnosed individuals with PD (<2y) participating in the Phase II study of prasinezumab (PASADENA) were analyzed...Conclusions Sensor data passively acquired from smartphones and smartwatches, as early-PD patients go about their daily lives, were significantly related to patients’ perceived QoL and health status. These findings may inform future endeavors to develop digital outcome scores that assess meaningful, QoL-affecting impairment in motor function.
- prasinezumab (RG7935) / Roche
[VIRTUAL] MEASURING MOTOR BEHAVIOR IN DAILY LIFE WITH SENSORS: PRELIMINARY RELIABILITY AND VALIDITY IN INDIVIDUALS RECENTLY DIAGNOSED WITH PARKINSON’S DISEASE (EXHIBITION HALL) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_680;
Methods Baseline data from 248 recently diagnosed individuals with PD (i.e. ≤2 y) participating in the Phase II study of prasinezumab (PASADENA) were analyzed...Conclusions These findings provide preliminary support for the reliability and validity of (passively) monitored daily motor behavior with smartphones and -watches in the Roche PD Mobile Application v2. These findings are especially notable in the context of the overall low levels of impairment in this early PD population.
- prasinezumab (RG7935) / Roche
[VIRTUAL] A PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PRASINEZUMAB IN EARLY PARKINSON'S DISEASE (PASADENA): RATIONALE, DESIGN AND BASELINE DATA (Hall F2) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_275;
Baseline data of PASADENA participants, including demographic characteristics, motor and non-motor symptoms, imaging and non-imaging biomarkers will be presented. Conclusions This trial is designed to provide an initial evaluation of Prasinezumab’s effects on clinical progression and loss of dopaminergic terminals measured by DaT-SPECT imaging in patients with early Parkinson’s disease and to inform future patient selection and Phase 3 study design.
- | prasinezumab (RG7935) / Roche
Clinical, Journal: Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-α-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. (Pubmed Central) - Oct 10, 2019
P1, P2
Findings support the design of an ongoing phase 2 clinical study (NCT03100149). ClinicalTrials.gov Identifier: NCT02157714.
- prasinezumab (RG7935) / Roche
Preliminary validation of a novel, comprehensive digital biomarker smartphone application to assess motor symptoms in de-novo diagnosed Parkinson patients (Agora 2 West, Level 2) - Sep 24, 2019 - Abstract #MDSCongress2019MDS_662;
A smartphone application (app) comprised of 10 active tests (tremor, bradykinesia, rigidity/postural stability, cognition) and continuous passive monitoring is deployed in a Phase II study of Prasinezumab (PASADENA) in recently diagnosed PD patients...These results suggest that a comprehensive remote monitoring approach with smartphones and smartwatches is feasible and provide preliminary evidence of that sensor features are reliable and valid measures of motor symptom severity in recently diagnosed PD patients. The frequent sampling enabled by the remote monitoring approach, coupled with the high sensitivity of smartphone/-watch sensors, promises to increase signal-to-noise in measurements of motor symptom progression in clinical research and, in the future, also routine clinical assessments.
- prasinezumab (RG7935) / Roche
Digital biomarker sensor feature data reflect quality of life judgements (PDQ39) in recently diagnosed Parkinson’s disease patients (Agora 2 West, Level 2) - Sep 24, 2019 - Abstract #MDSCongress2019MDS_290;
These findings are notable in the context of the overall low rate of self-reported impairments. The pattern of relationships supports the convergent/divergent validity of the digital sensor data from active tests and passive monitoring.
- ||| prasinezumab (RG7935) / Roche
Enrollment closed, Trial primary completion date: PASADENA: A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (clinicaltrials.gov) - Dec 17, 2018
P2, N=316, Active, not recruiting, Sponsor: Hoffmann-La Roche
The pattern of relationships supports the convergent/divergent validity of the digital sensor data from active tests and passive monitoring. Trial primary completion date: Mar 2020 --> Dec 2019 | Recruiting --> Active, not recruiting
- |||| prasinezumab (RG7935) / Roche
Enrollment open: PASADENA: A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (clinicaltrials.gov) - Dec 10, 2018
P2, N=300, Recruiting, Sponsor: Hoffmann-La Roche
Trial primary completion date: Mar 2020 --> Dec 2019 | Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting
- ||| prasinezumab (RG7935) / Roche
Enrollment closed: PASADENA: A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (clinicaltrials.gov) - Dec 7, 2018
P2, N=316, Active, not recruiting, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting
- || prasinezumab (RG7935) / Roche
Trial completion date: PASADENA: A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (clinicaltrials.gov) - May 31, 2018
P2, N=300, Recruiting, Sponsor: Hoffmann-La Roche
Recruiting --> Active, not recruiting Trial completion date: Jun 2021 --> Feb 2021
- || prasinezumab (RG7935) / Roche
Trial primary completion date: PASADENA: A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (clinicaltrials.gov) - Sep 12, 2017
P2, N=300, Recruiting, Sponsor: Hoffmann-La Roche
Trial completion date: Jun 2021 --> Feb 2021 Trial primary completion date: Jul 2019 --> Mar 2020
- |||| prasinezumab (RG7935) / Roche
Enrollment open: PASADENA: A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (clinicaltrials.gov) - Jun 5, 2017
P2, N=300, Recruiting, Sponsor: Hoffmann-La Roche
Trial primary completion date: Jul 2019 --> Mar 2020 Not yet recruiting --> Recruiting
- ||||| prasinezumab (RG7935) / Roche
New P2 trial: PASADENA: A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease (clinicaltrials.gov) - Apr 4, 2017
P2, N=300, Not yet recruiting, Sponsor: Hoffmann-La Roche
- ||| prasinezumab (RG7935) / Roche
Trial completion: Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease (clinicaltrials.gov) - Oct 21, 2016
P1, N=64, Completed, Sponsor: Prothena Biosciences Limited
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || prasinezumab (RG7935) / Roche
Enrollment closed: Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease (clinicaltrials.gov) - Mar 30, 2016
P1, N=64, Active, not recruiting, Sponsor: Prothena Biosciences Limited
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || prasinezumab (RG7935) / Roche
Trial primary completion date: Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease (clinicaltrials.gov) - Mar 23, 2016
P1, N=64, Recruiting, Sponsor: Prothena Biosciences Limited
Recruiting --> Active, not recruiting Trial primary completion date: Jan 2016 --> Oct 2016
- | prasinezumab (RG7935) / Roche
Trial completion: Single Ascending Dose Study of PRX002 in Healthy Subjects (clinicaltrials.gov) - Feb 10, 2015
P1, N=40, Completed, Sponsor: Prothena Biosciences Limited
Trial primary completion date: Jan 2016 --> Oct 2016 Active, not recruiting --> Completed
- prasinezumab (RG7935) / Roche
Enrollment closed: Single Ascending Dose Study of PRX002 in Healthy Subjects (clinicaltrials.gov) - Dec 5, 2014
P1, N=40, Active, not recruiting, Sponsor: Neotope Biosciences Limited, a subsidiary of Prothena Corporation plc
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| prasinezumab (RG7935) / Roche
New P1 trial: Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's Disease (clinicaltrials.gov) - Jun 4, 2014
P1, N=60, Recruiting, Sponsor: Neotope Biosciences Limited
- | prasinezumab (RG7935) / Roche
New P1 trial: Single Ascending Dose Study of PRX002 in Healthy Subjects (clinicaltrials.gov) - Mar 20, 2014
P1, N=40, Recruiting, Sponsor: Neotope Biosciences Limited