Prasinezumab
- Generic Name
- Prasinezumab
- Drug Type
- Biotech
- CAS Number
- 1960462-19-4
- Unique Ingredient Identifier
- P3Z0Z3P1ZI
- Background
Prasinezumab is under investigation in clinical trial NCT03100149 (A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's Disease).
Roche Advances Parkinson's Disease Research with Novel Assessment Methods and Digital Health Technologies
• Roche presented exploratory biomarkers for prasinezumab showing trends toward reduced neuromelanin loss and iron accumulation in brain regions affected by Parkinson's disease, potentially addressing the critical need for disease-modifying therapies.
• Digital Health Technologies (DHTs) demonstrated ability to detect disease progression in early Parkinson's patients on stable symptomatic treatment, with the bradykinesia simple sum score showing high test-retest reliability of 0.87.
• These advancements address a significant unmet need identified by key opinion leaders: the development of validated clinical endpoints and biomarkers to evaluate disease progression in Parkinson's disease clinical trials.
Prothena's Birtamimab Shows Promise in Phase 3 Trial for AL Amyloidosis with Focus on High-Risk Patients
• Prothena's Phase 3 AFFIRM-AL trial evaluates birtamimab in Mayo stage 4 AL amyloidosis patients, targeting a survival benefit with a p-value threshold of 0.10 per FDA agreement.
• Approximately 80% of trial participants are receiving daratumumab as standard of care, with researchers expecting mortality trends similar to previous VITAL trial observations.
• The company estimates 16,000 diagnosed and treated AL amyloidosis patients in the US, highlighting significant market potential for an anti-amyloid therapy that directly clears amyloid from vital organs.
Roche Launches SKYLINE: Four-Year Prevention Trial for Gantenerumab in Early-Stage Alzheimer's
• Roche initiates SKYLINE study, enrolling 1,250 participants aged 60-80 with early biological markers of Alzheimer's but no cognitive impairment, to evaluate gantenerumab's effectiveness in disease prevention.
• The study represents a significant investment in Alzheimer's research, featuring collaboration with prestigious institutions including Banner Alzheimer's Institute and Massachusetts General Hospital.
• Gantenerumab offers a potential advantage with its subcutaneous home administration option, distinguishing it from competitors requiring clinical infusions.
Inhibikase Halts Parkinson's Drug Development Following Phase II Trial Setback
• Inhibikase Therapeutics discontinues development of risvodetinib for Parkinson's disease after Phase II trial fails to show significant efficacy despite meeting safety endpoints.
• While the drug showed modest improvements in specific measures, including a 1.41-point improvement in MDS-UPDRS Part 2 scores at 100mg dosage, it failed to meet the primary functional endpoints.
• The company will pivot to focus on IkT-001Pro for pulmonary arterial hypertension, marking another setback in the challenging landscape of Parkinson's drug development.
FDA Expands Evrysdi Approval to Include Infants Under Two Months with Spinal Muscular Atrophy
• Roche and PTC Therapeutics' oral SMA drug Evrysdi (risdiplam) receives FDA approval for use in infants younger than two months, enabling treatment across all age groups from newborns to adults.
• The RAINBOWFISH study demonstrated significant efficacy, with treated pre-symptomatic babies achieving key developmental milestones including sitting, standing, and walking within 12 months.
• The expanded approval positions Evrysdi to compete directly with Biogen's Spinraza and Novartis' Zolgensma, while offering the advantage of at-home oral administration.
Medtronic's BrainSense Adaptive DBS Receives CE Mark for Personalized Parkinson's Therapy
• Medtronic's BrainSense Adaptive Deep Brain Stimulation (aDBS) and Electrode Identifier (EI) have received CE Mark approval in the EU and UK.
• The aDBS system offers real-time, self-adjusting brain stimulation for Parkinson's disease, adapting to individual patient's unique brain activity.
• BrainSense Electrode Identifier improves DBS programming by facilitating optimal initial contact selection, reducing programming time for clinicians.
• The first European patient has already been programmed with the new system at Amsterdam University Medical Center, marking a significant advancement.
Duvakitug Shows Promise in Phase 2 Ulcerative Colitis Trial with 50% Symptom Resolution Rate
A Phase 2 trial of duvakitug, jointly developed by Teva and Sanofi, has demonstrated significant efficacy in treating ulcerative colitis. The experimental antibody drug achieved symptom resolution in approximately 50% of patients receiving high doses after 14 weeks, compared to 20% in the placebo group.
Prasinezumab Phase IIb Trial Fails Primary Endpoint, Shows Promise in Parkinson's Subgroup
• Genentech's prasinezumab Phase IIb PADOVA study in early-stage Parkinson's missed its primary endpoint of delaying motor progression.
• A pre-specified analysis showed a more pronounced effect in patients treated with levodopa (HR=0.79), suggesting a potential benefit in this subgroup.
• The investigational monoclonal antibody continues to be well-tolerated, with ongoing open-label extension studies to further explore observed effects.
• Roche plans to present full PADOVA study results at an upcoming medical meeting and will work with health authorities to determine next steps.
UCB's Minzasolmin Fails Phase 2 ORCHESTRA Trial for Early Parkinson's Disease
• UCB's minzasolmin, an oral alpha-synuclein misfolding inhibitor, did not meet primary or secondary endpoints in the Phase 2 ORCHESTRA trial for early Parkinson's.
• The ORCHESTRA study enrolled over 450 patients to assess minzasolmin's efficacy, safety, tolerability, and pharmacokinetics over 12-18 months.
• UCB will terminate the extension phase of the minzasolmin program and shift focus to glovadalen (UCB0022) and UCB7583 for Parkinson's treatment.
• Analysis of disease biomarker data from the ORCHESTRA study is ongoing, with findings to be submitted for publication in a peer-reviewed journal.
Alzheimer's Research Faces Scrutiny Amidst Rising Concerns of Scientific Misconduct
• Neurologist Matthew Schrag highlights the increasing prevalence of research misconduct in Alzheimer's disease studies, which he believes has slowed the development of effective treatments.
• Schrag identifies image manipulation, overly perfect data, and data aligning too perfectly with hypotheses as potential red flags for research fraud.
• He emphasizes the need for greater transparency and data sharing within the scientific community to address and rectify instances of misconduct.
• Concerns are raised about the ethical implications of ongoing clinical trials based on potentially flawed data, urging regulatory agencies to prioritize patient safety.
Parkinson's Disease Research Focuses on Disease-Modifying Therapies
• Research in the seven major markets (7MM) increasingly prioritizes disease-modifying therapies (DMTs) and treatments for non-motor symptoms of Parkinson's disease.
• 66% of the 93 products in Phase I-III development are prospective neuroprotective agents or DMTs targeting mechanisms like alpha-synuclein aggregation and neuroinflammation.
• 26% of pipeline DMTs target alpha-synuclein aggregation, though this approach has faced setbacks, highlighting the complexity of Parkinson's pathogenesis.
• There is also growing research into treatments for non-motor symptoms, with 3% of the pipeline specifically targeting Parkinson's disease dementia and psychosis.
Parkinson's Disease Research Focuses on Disease-Modifying Therapies
• Clinical research in the seven major markets (7MM) for Parkinson's disease (PD) is heavily focused on disease-modifying therapies (DMTs) to address unmet needs.
• 66% of the 93 products in Phase I-III development are prospective neuroprotective agents or DMTs targeting mechanisms like alpha-synuclein aggregation and neuroinflammation.
• Researchers are also focusing on therapies for non-motor symptoms and postural instability, with 18% of the pipeline classified as 'other antiparkinsonian agents'.
Prasinezumab Shows Sustained Benefit in Parkinson's Disease Motor Progression
• An exploratory analysis of the PASADENA trial indicates that early-start prasinezumab shows sustained reduction in motor progression in Parkinson's disease over four years.
• The study compared PASADENA trial participants with an external comparator arm from the Parkinson’s Progression Markers Initiative (PPMI) cohort.
• Disease modeling and propensity score analysis supported the finding that prasinezumab may slow motor decline, irrespective of symptomatic treatment.
• These findings suggest prasinezumab's potential as a disease-modifying agent for early-stage Parkinson's disease, warranting further investigation.
Device-Assisted Dopamine Therapy and TAK-071 Show Promise in Parkinson's Disease
• A device-assisted therapy delivering dopamine directly to the brain shows potential in treating Parkinson's disease by improving symptom control without dyskinesia.
• TAK-071, an acetylcholine M1 receptor positive allosteric modulator, improved cognition in Parkinson's patients with cognitive impairment in a Phase 2 trial.
• Subcutaneous carbidopa/levodopa demonstrates improved motor function, daily activities, sleep, and quality of life compared to oral formulations for Parkinson's.
• Adaptive deep brain stimulation (DBS) is preferred by patients and may become the standard of care, offering personalized electrical stimulation based on brain activity.
AbbVie's Tavapadon Shows Positive Phase 3 Results for Parkinson's Disease
• AbbVie's tavapadon met its primary endpoint in the Phase 3 TEMPO-1 trial, significantly improving disease burden in early Parkinson's patients.
• The trial also achieved a key secondary endpoint, demonstrating clinically meaningful improvements in motor aspects of daily living compared to placebo.
• Tavapadon is a selective D1/D5 dopamine receptor partial agonist, potentially offering a novel approach to managing Parkinson's symptoms.
• AbbVie plans to submit the TEMPO-1 data for regulatory approval, with results from the TEMPO-2 trial expected by the end of 2024.
Genentech's Phase IIb Study of Prasinezumab in Early-Stage Parkinson's Disease Misses Primary Goal
Genentech's Phase IIb study on Prasinezumab for early-stage Parkinson's disease did not meet its primary endpoint, but indicated potential benefits with a numerical delay in motor progression and positive trends on secondary endpoints.
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