Lu AF20513 / Lundbeck, Otsuka - LARVOL DELTA

Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD (clinicaltrials.gov) - P1; N=3; Terminated; Sponsor: H. Lundbeck A/S; Trial primary completion date: Mar 2019 ➔ Jun 2019

Trial primary completion date

Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - P1; N=50; Terminated; Sponsor: H. Lundbeck A/S; Trial primary completion date: Jan 2019 ➔ Jul 2019

Clinical • Trial primary completion date

A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD) (clinicaltrials.gov) - P1; N=18; Terminated; Sponsor: H. Lundbeck A/S; Trial primary completion date: Feb 2019 ➔ May 2019

Clinical • Trial primary completion date

Study to Evaluate the Safety and Tolerability of a New Drug Named Lu AF20513 in Patients With Mild Alzheimer's Disease (clinicaltrials.gov) - P1; N=50; Terminated; Sponsor: H. Lundbeck A/S; Trial completion date: Dec 2019 ➔ Jul 2019; Active, not recruiting ➔ Terminated; Trial primary completion date: Oct 2019 ➔ Jan 2019; New data: The study was terminated based on new efficacy data from another study

Clinical • Trial completion date • Trial primary completion date • Trial termination

Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD (clinicaltrials.gov) - P1; N=3; Terminated; Sponsor: H. Lundbeck A/S; N=28 ➔ 3; Trial completion date: Dec 2019 ➔ Jun 2019; Active, not recruiting ➔ Terminated; Trial primary completion date: Dec 2019 ➔ Mar 2019; New data: The study was terminated based on new efficacy data from another study

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination

A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD) (clinicaltrials.gov) - P1; N=18; Terminated; Sponsor: H. Lundbeck A/S; Active, not recruiting ➔ Terminated; New data: The study was terminated based on new efficacy data from another study

Clinical • Trial termination

Product discontinued (Lundbeck Press Release) - Alzheimer's Disease

Discontinuation

Double-digit growth for all strategic brands and DKK 4,234 million in revenue and DKK 1,200 million in EBIT (Lundbeck Press Release) - "Lu AF20513 – phase I...It has been decided to discontinue the development project currently in phase I following increased uncertainty around the biological rationale. Lundbeck continues to be committed to developing treatments for Alzheimer’s."

Discontinuation

A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD) (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: H. Lundbeck A/S; Enrolling by invitation ➔ Active, not recruiting; N=57 ➔ 18; Trial completion date: Feb 2022 ➔ May 2019; Trial primary completion date: Feb 2022 ➔ May 2019

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD (clinicaltrials.gov) - P1; N=28; Active, not recruiting; Sponsor: H. Lundbeck A/S; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: H. Lundbeck A/S; Trial completion date: Jun 2019 ➔ Jan 2020; Trial primary completion date: Apr 2019 ➔ Jan 2020

Clinical • Trial completion date • Trial primary completion date

A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD) (clinicaltrials.gov) - P1; N=57; Enrolling by invitation; Sponsor: H. Lundbeck A/S; Trial completion date: Nov 2020 ➔ Feb 2022; Trial primary completion date: Nov 2020 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date

Study With Lu AF20513 in Patients With Mild Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI) Due to AD (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: H. Lundbeck A/S

Clinical • New P1 trial

IMMUNOLOGICAL AGENTS FOR NEUROCOGNITIVE DISORDERS- A REVIEW OF THE CURRENT EVIDENCE (EPA 2019) - "Finished trials with published Results were investigating a tau vaccine (AADvac 1- positive Results , phase 1 trial) and several vaccines directed against beta-amyloid plaques (ACC-001- negative Results , two phase 2A trials, gantenerumab- it may be efficient, but more trials are needed, bapineuzumab failed, phase 3 trial, BAN2401- it was efficient in a single phase 2A trial, AN1792- phase 2A trial produced positive effects and a follow-up after 4.6 years detected low anti-AN1792 antibody titers, and CAD106- only a phase 1 trial). The level of evidence for current immunological therapies targeting AD is not very encouraging, but many trials are currently ongoing or will start in near future."