GSK4527226 / Alector, GSK - LARVOL DELTA

Alector Announces Completion of Enrollment in the PROGRESS-AD Phase 2 Clinical Trial of AL101/GSK4527226 in Individuals with Early Alzheimer’s Disease (GlobeNewswire) - "Alector, Inc...announced the completion of enrollment in PROGRESS-AD, a 76-week Phase 2 clinical trial evaluating the safety and efficacy of AL101/GSK4527226 in slowing disease progression in individuals with early Alzheimer’s disease (AD)."

Enrollment closed • Alzheimer's Disease

PROGRESS-AD: Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P2 | N=359 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

PROGRESS-AD: Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P2 | N=282 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Feb 2029 ➔ Nov 2026

Trial completion date • Alzheimer's Disease • CNS Disorders

Alector Reports on Recent Progress and Outlines Strategic Priorities for 2025 (GlobeNewswire) - "Topline data from the pivotal INFRONT-3 Phase 3 clinical trial of latozinemab in FTD-GRN expected by Q4 2025; Completion of enrollment in the PROGRESS-AD Phase 2 trial of AL101/GSK4527226 for early Alzheimer’s disease anticipated in mid-2025, with approximately 75% target recruitment achieved..."

Enrollment status • P3 data: top line • Alzheimer's Disease • Dementia • Frontotemporal Lobar Degeneration

Drug Development. (PubMed, Alzheimers Dement) - P2 | "This study of the anti-sortilin antibody, GSK4527226, will comprehensively evaluate its efficacy, safety and effects on pathogenesis in early AD."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Inflammation • GRN • SORT1

Alector to Present Data on Pipeline Focus Areas at the Alzheimer’s Association International Conference (AAIC) 2024 (GlobeNewswire) - "Alector, Inc...today announced presentations related to the Company’s TREM2 and progranulin programs at the upcoming Alzheimer's Association International Conference 2024 (AAIC) being held online and in Philadelphia, Pennsylvania from July 28 – August 1, 2024. Poster presentations will be available for on-demand viewing beginning on July 28 at 8:00 a.m. ET."

Clinical • P2 data • Preclinical • Alzheimer's Disease • CNS Disorders

PROGRESS-AD: a phase 2 study to evaluate efficacy and safety of GSK4527226 (AL101), an anti-sortilin monoclonal antibody, in patients with early Alzheimer's disease (AAIC 2024) - P2 | "This study of the anti-sortilin antibody, GSK4527226, will comprehensively evaluate its efficacy, safety and effects on pathogenesis in early AD."

Clinical • P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Inflammation • GRN • SORT1

Alector Reports First Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Alector and GSK plan to present a poster on the design of the AL101 Phase 2 trial at the Alzheimer's Association International Conference 2024 (AAIC) in Philadelphia from July 28 to August 1, 2024....The INVOKE-2 Phase 2 clinical trial of AL002 is fully enrolled, and data from the trial are anticipated in the fourth quarter of 2024."

Clinical protocol • Enrollment closed • P2 data • Alzheimer's Disease • CNS Disorders

PROGRESS-AD: Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P2 | N=282 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

Alector Announces First Patient Dosed in PROGRESS-AD Phase 2 Clinical Trial of AL101/GSK4527226 in Patients with Early Alzheimer’s Disease (Yahoo Finance) - "Alector, Inc...and GSK plc...today announced that the first patient has been dosed in PROGRESS-AD, the global Phase 2 clinical trial of AL101/GSK4527226 in patients with early Alzheimer’s disease (AD), including mild cognitive impairment and mild dementia due to AD. AL101 is an investigational human monoclonal antibody designed to block and downregulate the sortilin receptor to elevate the level of progranulin in the brain in a manner similar to investigational latozinemab but with different pharmacokinetic (PK) and pharmacodynamic (PD) properties."

Trial status • Alzheimer's Disease • CNS Disorders

PROGRESS-AD: Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P2 | N=282 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P2 trial • Alzheimer's Disease • CNS Disorders

Repeat IV and SC Dosing of the Anti-Sortilin Antibody AL101 (AAN 2023) - "Conclusions Repeat IV or SC administration of AL101 is generally safe and well tolerated. AL101 is a potent modulator of PGRN levels in the CSF, with a PK/PD profile that supports its further development in neurodegenerative diseases."

Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • Movement Disorders • Parkinson's Disease • SORT1

REPEAT IV AND SC DOSING OF THE ANTISORTILIN ANTIBODY AL101 (CTAD 2022) - "Multiple IV or SC administration of AL101 is generally safe and well tolerated in healthy volunteers. AL101 is a potent modulator of PGRN levels in the CSF, with a PK/PD profile that supports its further development in chronic neurological conditions such as Alzheimer’s and Parkinson’s disease."

Alzheimer's Disease • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • Immunology • Movement Disorders • Parkinson's Disease • SORT1

Alector Presents Results from First-in-Human Phase 1 Study of AL101 for the Treatment of Neurodegenerative Diseases (GlobeNewswire) - P1 | N=88 | NCT04111666 | Sponsor: Alector Inc. | “Alector, Inc…reported safety and biomarker data from a first-in-human Phase 1 healthy volunteer study of AL101…The data will be presented today during a poster session at the 15th Clinical Trials on Alzheimer's Disease (CTAD) conference held in San Francisco from November 29–December 2, 2022. AL101 is being developed for the potential treatment of neurodegenerative diseases, including Alzheimer’s disease (AD) and Parkinson’s disease (PD)…AL101 was found to be generally well tolerated following MD IV (q4w) and SC (q2w) administrations….MD administration of AL101 increased plasma and CSF PGRN levels, with a higher elevation observed in the AL101 30 mg/kg MD IV group than in the AL101 300 mg MD SC group. Multiple IV doses of AL101 at 30 mg/kg increased and maintained the levels of PGRN at approximately 160% to 200% (2.6- to 3-fold) above baseline in plasma..."

Biomarker • P1 data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101 (clinicaltrials.gov) - P1 | N=88 | Completed | Sponsor: Alector Inc. | Active, not recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ Jun 2022

Trial completion • Trial completion date

Alector Reports Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - “Progranulin Assets (Latozinemab, AL101): The company expects to report data at a medical conference later this year from the Phase 1 trial of AL101 in healthy volunteers. AL101 is being developed to elevate progranulin levels in a manner similar to latozinemab (AL001) with plans to investigate AL101 for the treatment of AD and Parkinson’s disease….Total research and development expenses for the quarter ended June 30, 2022, were $54.5 million, compared to $47.8 million for the quarter ended June 30, 2021. The increase in R&D expenses was mainly driven by increased personnel-related expenses, including stock-based compensation, as well as an increase in AL101 expenses.”

Commercial • P1 data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101 (clinicaltrials.gov) - P1 | N=79 | Active, not recruiting | Sponsor: Alector Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

Alector Reports First Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Alector, Inc...today reported first quarter 2022 financial results and recent portfolio and business updates. As of March 31, 2022, Alector’s cash, cash equivalents, and marketable securities totaled $868.6 million....Alector completed enrollment in the ongoing Phase 1 clinical trial to test multiple doses of AL101 administered intravenously and subcutaneously....The company expects to report data from the Phase 1 trial in the second half of 2022."

Enrollment closed • P1 data • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

A First-in-Human Study of the Anti-Sortilin Antibody AL101 (AAN 2022) - "AL101 was generally safe and well tolerated with single-dose IV or SC administration in healthy volunteers. AL101 is a potent modulator of PGRN levels in the CSF, with a PK/PD profile that supports development of SC AL101 in chronic conditions."

P1 data • Alzheimer's Disease • Anemia • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • Hematological Disorders • Immunology • Movement Disorders • Pain • Parkinson's Disease • SORT1

Development of the Monoclonal Antibody AL101 to block the Sortilin/Progranulin Interaction as a Potential Therapy for Neurodegenerative Diseases (AAN 2022) - "AL101 is being developed for the treatment of Alzheimer's Disease and Parkinson's Disease."

Alzheimer's Disease • CNS Disorders • Immunology • Inflammation • Movement Disorders • Parkinson's Disease • SORT1

Alector Reports Fourth Quarter and Full Year 2021 Financial Results (Yahoo Finance) - “Twelve-month data from Alector’s INFRONT-2 Phase 2 clinical trial of AL001 in a cohort of patients with FTD with a C9orf72 genetic mutation have been accepted for presentation at the International Conference on Alzheimer’s and Parkinson’s Diseases (ADPD) in March 2022….The AL101 Phase 1 study is continuing to enroll additional cohorts to test further dosages of AL101 administered intravenously or subcutaneously and is expected to be completed by the end of 2022….Alector plans to initiate the first-in-human study for AL044 in the second half of 2022. AL044 targets MS4A, a risk gene family for Alzheimer’s disease.”

New trial • P2 data • Trial completion date • Alzheimer's Disease • CNS Disorders • Frontotemporal Lobar Degeneration • Parkinson's Disease

A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101 (clinicaltrials.gov) - P1; N=79; Recruiting; Sponsor: Alector Inc.; N=53 ➔ 79; Trial completion date: Oct 2021 ➔ Sep 2022; Trial primary completion date: Aug 2021 ➔ Jun 2022

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

Alector Presents New Data from Multiple Pipeline Programs at 2021 CTAD Conference (Yahoo Finance) - P1, N=54; INTERCEPT (NCT03822208); P1, N=53; NCT04111666; Sponsor: Alector Inc.; “Alector, Inc…shared data from its AL003 and AL101 programs in poster presentations…AL003 showed a favorable safety and pharmacokinetic profile for once-monthly intravenous dosing. AL003 demonstrated target engagement of CD33 in both blood and central nervous system (CNS) compartments at well tolerated doses…Phase 2 trial evaluating AL003 for the treatment of early Alzheimer’s disease is being planned for the second half of 2022….AL101 was found to be generally safe and well tolerated. The majority of on-study adverse events (AEs) were considered mild to moderate in severity, with the most frequent AEs being headache, anemia and procedural pain….Data for AL003 and AL101, as well as a trial design poster for the Phase 3 INFRONT-3 clinical trial of AL001, are being presented at CTAD in poster presentations.”

Clinical protocol • New P2 trial • P1 data • Alzheimer's Disease • CNS Disorders • Frontotemporal Lobar Degeneration

A First-in-human Study of the anti-Sortilin antibody AL101 (CTAD 2021) - "AL101 has been generally safe and well tolerated with single-dose IV or SC administration in healthy volunteers. AL101 is a potent modulator of PGRN levels in the CSF, with a PK/PD profile that supports development of SC AL101 in chronic conditions."

P1 data • Alzheimer's Disease • Anemia • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • Hematological Disorders • Immunology • Movement Disorders • Pain • Parkinson's Disease • SORT1

ONCOTELIC TO ACQUIRE LATE-STAGE DRUG CANDIDATE FOR PARKINSON DISEASE, ERECTILE DYSFUNCTION, AND FEMALE SEXUAL DYSFUNCTION. (GlobeNewswire) - "Oncotelic Therapeutics, Inc...executed a binding term sheet with Autotelic Inc. to license AL-101 (intranasal apomorphine). Oncotelic intends to develop AL-101 via fast-to-market 505(b)2 regulatory pathway for Parkinson Disease ('PD')..."

Licensing / partnership • Parkinson's Disease