MEDI1341 / AstraZeneca, Takeda - LARVOL DELTA

An update on immune-based alpha-synuclein trials in Parkinson's disease. (PubMed, J Neurol) - "Specifically, UB-312, AFFITOPE PD01A, PD03A and ACI-7104.056 are designed to provoke an immune response against α-syn (active immunisation), while Prasinezumab and Cinpanemab, MEDI1341 and Lu AF82422 focus on directly targeting α-syn aggregates (passive immunisation). Despite some promising results, challenges such as variable efficacy and trial discontinuations persist. Future research must address these challenges to advance disease-modifying therapies for PD around this therapeutic target."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

A Study of TAK-341 in Treatment of Multiple System Atrophy (clinicaltrials.gov) - P2 | N=159 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Multiple System Atrophy

Study Design of TAK-341-2001: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-341 in Subjects With Multiple System Atrophy (AAN 2023) - P1, P2 | "Safety endpoints will also be evaluated. Results Recruiting Conclusions Trial results will yield insight into the role of alpha-synuclein in MSA disease progression, and further inform TAK-341’s risk-benefit profile."

Clinical • CNS Disorders • Movement Disorders • Multiple System Atrophy • Parkinson's Disease

Reducing a-Synuclein in Human CSF; An Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI1341, an a-Synuclein-specific antibody, in Healthy Volunteers and Parkinson’s Disease Patients (AAN 2023) - P1 | "The PK and PD data provide evidence of dose-dependent and selective ASN target engagement by MEDI1341 in the central compartment. Full study design and data from the Phase 1 studies will be presented."

Clinical • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease

IMMUNE RESPONSE AND IMMUNIZATION IN PARKINSON'S DISEASE: QSP MODELLING (ADPD 2023) - "Our QSP model reproduces data on α -synuclein accumulation in the CNS of PD mice, microglia activation and MHCII upregulation, which helps to recruit T -cells and aggravate inflammation, impair α -synuclein clearance and immune - mediated neurotoxicity. It also reproduces data on reduction of free synuclein in CSF and reduced brain synuclein accumulation after anti α -synuclein antibody MEDI1341 administration or vaccination by PV -1950D. Anti bodies restored dopaminergic loss in the model and reduced microgliosis in accordance with in vivo data from mice."

IO biomarker • CNS Disorders • Immune Modulation • Immunology • Inflammation • Movement Disorders • Parkinson's Disease • IFNG • IL10 • IL17A • IL6

A Study of TAK-341 in Treatment of Multiple System Atrophy (clinicaltrials.gov) - P2 | N=138 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Multiple System Atrophy

MEDI1341: Data from P1 trial (NCT04449484) for Parkinson's disease in Q4 2022 (AstraZeneca) - Q3 2022 Results

P1 data • CNS Disorders • Parkinson's Disease

A Study to evaluate Efficacy, Safety, Tolerability and Effects of TAK-341 in the human body in patients with Multiple System Atrophy (clinicaltrialsregister.eu) - P2 | N=138 | Ongoing | Sponsor: Takeda Development Center Americas, Inc.

New P2 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy

A Study of TAK-341 in Treatment of Multiple System Atrophy (clinicaltrials.gov) - P2 | N=138 | Not yet recruiting | Sponsor: Takeda

New P2 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy

Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Jan 2022 | Trial primary completion date: Jul 2022 ➔ Jan 2022

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

MEDI1341: Data from P1 trial (NCT04449484) for Parkinson's disease in H2 2022 (AstraZeneca) - Q1 2022 Results

P1 data • CNS Disorders • Parkinson's Disease

MEDI1341: Data from P1 trial (NCT04449484) for Parkinson's disease in H1 2022 (AstraZeneca) - FY2021 Results

P1 data • CNS Disorders • Parkinson's Disease

Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease (clinicaltrials.gov) - P1; N=25; Active, not recruiting; Sponsor: AstraZeneca; Recruiting ➔ Active, not recruiting; N=36 ➔ 25

Clinical • Enrollment change • Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease • MRI

MEDI1341: Data from P1 trial (NCT03272165) for healthy volunteers in Q4 2021 (AstraZeneca) - Q3 2021 Results: Data from P1 trial (NCT04449484) for Parkinson’s disease in 2022 or later

P1 data • CNS Disorders • Parkinson's Disease

MEDI1341: Regulatory approval for Parkinson's disease in FY 2025 or later (Takeda) - Q1 FY2021 Results

Regulatory • CNS Disorders • Parkinson's Disease

MEDI1341: Data from P1 trial (NCT03272165) in healthy volunteers in H2 2021 (AstraZeneca) - H1 2021 Results

P1 data • CNS Disorders • Parkinson's Disease

Immunotherapies for Parkinson's disease: Progression of Clinical Development. (PubMed, CNS Neurol Disord Drug Targets) - "This approach shows some positive outcomes on the efficacy in removing the aggregated species of alpha-synuclein, which is believed to be one of the causes of Parkinson's disease. In this review, an overview of how alpha-synuclein contributes to Parkinson's disease and the effects of a few new immunotherapeutic treatments, including BIIB054 (cinpanemab), MEDI1341, AFFITOPE and PRX002 (prasinezumab) that are currently under clinical development, will be discussed."

Clinical • Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

MEDI1341: Data from P1 trial (NCT03272165) in healthy volunteers in Q2 2021 (AstraZeneca) - Q1 2021 Results

P1 data • CNS Disorders • Parkinson's Disease

Single Ascending Dose Study of MEDI1341 in Healthy Volunteers (clinicaltrials.gov) - P1; N=49; Completed; Sponsor: AstraZeneca; Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

MEDI1341: Data from P1 trial (NCT03272165) in healthy volunteers in H1 2021 (AstraZeneca) - FY2020 Results: Data from P1 trial (NCT04449484) for Parkinson's disease in 2022 or later

P1 data • CNS Disorders • Parkinson's Disease

Single Ascending Dose Study of MEDI1341 in Healthy Volunteers (clinicaltrials.gov) - P1; N=41; Active, not recruiting; Sponsor: AstraZeneca; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

TAK-341: Regulatory approval for Parkinson's disease in FY 2027 or later (Takeda) - Wave 1 Pipeline Opportunity Call

Regulatory • CNS Disorders • Parkinson's Disease

Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: AstraZeneca; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

MEDI1341: Data from P1 trial (NCT04449484) for Parkinson's disease in 2021 or later (AstraZeneca) - Q3 2020 Results

P1 data • CNS Disorders • Parkinson's Disease

Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's Disease (clinicaltrials.gov) - P1; N=36; Active, not recruiting; Sponsor: AstraZeneca; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease