BMS-986495 / Prothena, BMS - LARVOL DELTA

Phase 1 Study of PRX019 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: Prothena Biosciences Ltd. | Recruiting ➔ Completed

First-in-human • Trial completion

Business Highlights and Upcoming Milestones (Businesswire) - "Roche is conducting the Phase 3 PARAISO clinical trial in approximately 900 participants with early-stage Parkinson's disease; primary completion expected in 2029 (NCT07174310)...Roche has stated that prasinezumab has peak sales potential greater than $3.5 billion...Bristol Myers Squibb is conducting the Phase 2 TargetTau-1 clinical trial in approximately 310 patients with early Alzheimer’s disease; primary completion expected in 1H 2027 (NCT06268886)...PRX019, a potential treatment of neurodegenerative diseases in development in collaboration with Bristol Myers Squibb...Prothena could potentially earn a $55 million clinical milestone payment if Bristol Myers Squibb decides to advance the program; BMS decision expected by YE 2026."

Pipeline update • Sales • Trial completion date • Alzheimer's Disease • Parkinson's Disease

Prothena Announces Corporate Restructuring (Businesswire) - "Company expects initial data in August from Phase 1 ASCENT clinical trials of its wholly owned PRX012 program in Alzheimer’s disease; Novo Nordisk expects to share data from its Phase 2 clinical trial evaluating coramitug for ATTR-CM in the second half of 2025; Company expects to complete a Phase 1 clinical trial for PRX019 in collaboration with Bristol Myers Squibb in 2026."

Clinical data • Trial status • Alzheimer's Disease • Amyloidosis • Cardiomyopathy

Prothena Reports Fourth Quarter and Full Year 2024 Financial Results, and Provides Financial Guidance and Business Highlights (Businesswire) - "PRX019: Phase 1 clinical trial expected to complete in 2026. Birtamimab: The ongoing confirmatory Phase 3 AFFIRM-AL clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA with a primary endpoint of all-cause mortality (time-to-event) at a statistical significance level of 0.10. Topline results from confirmatory Phase 3 AFFIRM-AL clinical trial expected in 2Q 2025. Coramitug: Phase 2 clinical trial has completed enrollment of approximately 99 patients with trial completion expected in 1H 2025."

P3 data: top line • Trial completion date • Amyloidosis • Cardiomyopathy • CNS Disorders

Phase 1 Study of PRX019 in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Prothena Biosciences Ltd.

New P1 trial

Prothena Announces Bristol Myers Squibb Opt-in for Exclusive Global License for PRX019, the Second Program from Global Neuroscience Research and Development Collaboration (Businesswire) - "Prothena Corporation plc...announced that Bristol Myers Squibb obtained the exclusive global license for PRX019 and will pay Prothena $80 million....Prothena plans to initiate the Phase 1 clinical trial for PRX019 by year-end 2024....As part of the PRX019 global license with Bristol Myers Squibb, Prothena will be eligible to receive additional development, regulatory, and sales milestone payments of up to $617.5 million. Prothena also will be eligible to receive tiered royalties on net sales."

Licensing / partnership • New P1 trial • CNS Disorders

Prothena Reports First Quarter 2024 Financial Results and Business Highlights (Businesswire) - "Topline results from Phase 2b PADOVA clinical trial in patients with early Parkinson’s disease, which has completed enrollment, expected in 2H 2024 (NCT04777331)...PRX019, a potential treatment of neurodegenerative diseases with an undisclosed target...Phase 1 clinical trial timeline update expected in 2024..."

Enrollment closed • New P1 trial • P2b data • CNS Disorders • Parkinson's Disease