PRX123 / Prothena - LARVOL DELTA

Prothena Reports First Quarter 2025 Financial Results and Business Highlights (Businesswire) - "PRX012: Prothena expects to report multiple clinical readouts starting around mid-2025 and continuing throughout the year from the ongoing Phase 1 ASCENT clinical trials. Prothena has currently enrolled approximately 260 patients in the ASCENT clinical trials BMS-986446 (formerly PRX005): Bristol Myers Squibb continues to enroll the ongoing Phase 2 Target Tau-1 clinical trial in approximately 475 patients with early Alzheimer’s disease; primary completion expected in 2027 (NCT06268886)....PRX123: Continuing to optimize capital allocation across our robust R&D pipeline, Prothena expects to update plans for Phase 1 clinical trial by year-end 2025....Prasinezumab: Roche will continue to evaluate data from PADOVA and will work together with health authorities to determine next steps around mid-year 2025."

New P1 trial • P1 data • P2b data • Trial completion date • Alzheimer's Disease • Parkinson's Disease

Prothena Reports Third Quarter 2024 Financial Results and Business Highlights (Businesswire) - "BMS-986446...Bristol Myers Squibb continues to enroll the ongoing Phase 2 clinical trial in approximately 475 patients with early Alzheimer’s disease; primary completion expected in 2027 (NCT06268886)...PRX123...Continuing to optimize capital allocation across our robust R&D pipeline, Prothena expects to update plans for Phase 1 clinical trial in 2025."

New P1 trial • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Prothena Reports First Quarter 2024 Financial Results and Business Highlights (Businesswire) - "The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PRX012 for the treatment of Alzheimer’s disease....Phase 1 clinical trial continues as planned and expect to update in 2024...The FDA cleared the investigational new drug (IND) application and granted Fast Track designation for PRX123 for the treatment of Alzheimer’s disease."

Fast track designation • IND • New trial • P1 data • Alzheimer's Disease • CNS Disorders

Dual Amyloid Beta/Tau Vaccine PRX123 Surrogate Results in Robust Clearance of Amyloid Plaques in Brains of Aggressive APP/PS1 Mouse Model (AAN 2024) - "These data demonstrate that PRX123 may generate high-quality antibody responses capable of clearing Aβ plaques at brain exposures that may be achievable in patients and support the continued development of PRX123 for the treatment and/or prevention of AD."

Preclinical • Alzheimer's Disease • CNS Disorders • APP • THY1

Prothena Provides Updates on PRX012, PRX123, Birtamimab and Portfolio Programs (Businesswire) - "PRX012...Ongoing Phase 1 trial continues as planned and expect to update in 2024....PRX123...Phase 1 timeline update expected in 2024 in order to optimize capital allocation across robust clinical portfolio..."

P1 data • Alzheimer's Disease • CNS Disorders

Prothena Reports Third Quarter 2023 Financial Results and Business Highlights (Businesswire) - P2 | N=312 | PASADENA (NCT03100149) | Sponsor: Hoffmann-La Roche | "PRX012...initial topline data expected by year-end 2023....Received $55 million payment from Bristol Myers Squibb for exclusive worldwide license to BMS-986446, optioned in July; Bristol Myers Squibb reported that Phase 1 data supports rapidly moving BMS-986446 into a Phase 2 clinical trial in first half 2024; PRX123....Investigational new drug (IND) application expected by year-end 2023....Roche presented data at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) from the open-label extension of the PASADENA study which shows that prasinezumab slowed the progression of motor deficits (MDS-UPDRS Part III OFF state score) in early-stage PD; Roche completed enrollment for the Phase 2b PADOVA clinical trial in patients with early PD (NCT04777331); topline results expected in 2024..."

Commercial • IND • New P2 trial • P1 data • P2 data • P2b data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Immunological response to dual Aβ/Tau vaccine PRX123 surrogate and effects on brain amyloid plaques in rapidly depositing transgenic animal model (AAIC 2023) - "Together these data demonstrate that PRX123 may be capable of generating high-quality antibody responses to clear Aβ plaques at brain exposures which may be achievable in patients and support the continued development of PRX123—a dual Aβ-tau conjugated linear peptide vaccine designed to treat and/or prevent Alzheimer’s disease."

Preclinical • Alzheimer's Disease • CNS Disorders • APP • THY1

Prothena Presents New Research in the Treatment of Alzheimer’s Disease at Alzheimer’s Association International Conference 2023 (AAIC) (Businesswire) - "Preclinical results demonstrated that a PRX123 vaccine surrogate elicited robust antibody responses that bound with high avidity to Aβ plaques in Alzheimer’s disease brain ex vivo and significantly reduced Aβ brain plaques in a transgenic mouse model of Alzheimer’s disease pathology....Results from two preclinical studies were presented comparing a PRX012-surrogate (PRX012s) to lecanemab and donanemab. In the first study, Surface Plasmon Resonance (SPR) was used to compare PRX012s to lecanemab and showed that PRX012s had approximately 20-fold higher affinity to Aβ protofibrils when compared to lecanemab, tested under the same conditions."

Preclinical • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies

Prothena to Present New Data from Alzheimer’s Disease Programs at Alzheimer’s Association International Conference 2023 (AAIC) (Businesswire) - "Prothena will highlight results in a poster presentation from a single ascending dose (SAD) study in healthy volunteers receiving PRX005...that specifically binds with high affinity to the R1, R2, and R3 repeats within the microtubule binding region (MTBR) of tau and targets both 3R and 4R tau isoforms....Prothena will present preclinical data in a late breaker poster presentation on the immunological response to the dual Aβ/Tau vaccine PRX123 surrogate and the effects on brain amyloid plaques in a rapidly depositing transgenic animal model....Prothena will present an encore poster presentation of data originally presented at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) on preclinical data from the PRX012 program comparing a PRX012-surrogate1 (PRX012s) with lecanemab and donanemab."

Clinical data • Preclinical • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies

Prothena Reports Fourth Quarter and Full Year 2022 Financial Results, and Provides Financial Guidance and Business Highlights (Businesswire) - “PRX012: Significant presence at upcoming International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) in March/April 2023 highlighted by oral presentation of preclinical data showing superior binding characteristics of PRX012 and a symposium featuring key thought leaders. Ongoing Phase 1 SAD and MAD studies; topline data expected year end 2023….PRX005: Ongoing Phase 1 MAD study; topline data expected year end 2023. PRX123: Investigational new drug (IND) application filing expected by year end 2023….NNC6019: Ongoing Phase 2 study in patients with ATTR cardiomyopathy is being conducted by Novo Nordisk (NCT05442047); topline data expected in 2024.”

IND • P1 data • P2 data • Preclinical • Alzheimer's Disease • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • CNS Disorders

Prothena Reports Third Quarter 2022 Financial Results and Business Highlights (Businesswire) - “Neurodegenerative Diseases Portfolio: Alzheimer’s Disease (AD): PRX012…Phase 1 multiple ascending dose (MAD) study initiation expected by year-end 2022; Topline data from Phase 1 study expected in 2023. PRX005…Topline data from Phase 1 study expected by year-end 2022; PRX123…IND filing expected in 2023….Research and development (R&D) expenses totaled $39.9 million and $98.7 million for the third quarter and first nine months of 2022, respectively, as compared to $18.0 million and $60.2 million for the third quarter and first nine months of 2021, respectively. The increase in R&D expense for the third quarter and first nine months of 2022 compared to the same periods in the prior year was primarily due to higher manufacturing costs primarily related to the birtamimab, PRX012, PRX019, PRX123 and PRX005 programs…”

Commercial • IND • New P1 trial • P1 data • Alzheimer's Disease • CNS Disorders

Prothena (PRTA) Stock Gains 51% in a Year: What Lies Ahead? (Yahoo Finance) - “The FDA recently cleared the investigational new drug (IND) application for Prothena’s PRX012…The company expects to initiate the phase I multiple ascending dose study by year-end 2022. Prothena is advancing an early-stage pipeline of programs for a number of potential neurological indications with Bristol Myers BMY. This includes PRX005 — a potential treatment for AD…A phase I study was initiated in 2021, and top-line data is expected in 2022. The company is also developing a dual Aβ-Tau vaccine…An IND for the vaccine is anticipated in 2023.”

IND • New P1 trial • P1 data • Alzheimer's Disease • CNS Disorders