A Multi-Centre, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 (AL101) in Participants With Early Alzheimer's Disease

The study medicine GSK4527226 is being studied in participants with Alzheimer's Disease (AD) in study 219867 (the parent study, NCT06079190). This new study is an extension of that parent study called an open-label extension (OLE). An OLE is a clinical trial where all participants receive the same study medicine. Participants must already be in study 219867 to be able to take part in this study. This study will assess the long-term safety and efficacy of GSK4527226 in participants with early AD (including mild cognitive impairment [MCI] and mild dementia due to AD) who have completed the parent study.

开始日期2025-08-14

申办/合作机构

GSK Plc

[+1]

NCT06079190

/ Active, not recruiting临床2期

A Phase 2, Parallel Group, Randomized, Double- Blind, Placebo-Controlled, 3-Arm, Multicenter Treatment Study to Evaluate the Efficacy and Safety of GSK4527226 [AL101] Intravenous Infusion Compared With Placebo in Patients With Early Alzheimer's Disease

The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment [MCI] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.

开始日期2023-10-20

申办/合作机构

GSK Plc

[+1]

100 项与 Nivisnebart 相关的临床结果

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100 项与 Nivisnebart 相关的转化医学

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100 项与 Nivisnebart 相关的专利（医药）

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项与 Nivisnebart 相关的新闻（医药）

2026-04-30

·EndPoints

Avalyn's upsized IPO; Alector ends another study in GSK partnership; Teva's $700M buy

🔔 Avalyn Pharma’s $300M IPO: The Boston, MA-based biotech is selling over 16.5 million shares at $18 apiece. The company is set to start trading as $AVLN on the Nasdaq Thursday with the offering expected to close Friday. It had originally targeted a $182 million IPO. Avalyn is advancing inhaled treatments for rare respiratory diseases. Its lead candidate, called AP01, is in Phase 2 development for progressive pulmonary fibrosis. The company has 51 full-time employees, according to an SEC filing . – Ayisha Sharma 🛑 Alector ends study for GSK-partnered Alzheimer’s drug: The California biotech said it is ending a Phase 2 trial of nivisnebart after an independent committee found it was unlikely to meet the primary endpoint. GSK and Alector plan to discuss their collaboration, which was signed in 2021 and included $1.5 billion in potential milestones. In October last year, another GSK-partnered candidate called latozinemab flunked a Phase 3 study in dementia. Alector’s first-generation antibody-based neurology platform had a separate disappointment in November 2024, when its AbbVie-partnered candidate AL002 failed a Phase 2 Alzheimer’s trial. – Ayisha Sharma 🤝 Teva to acquire Tourette’s drug company for $700M upfront: At the heart of the deal is Emalex’s ecopipam, which is on track for an NDA filing in the second half of the year. Emalex is also eligible for up to $200 million in commercial milestones and royalties. The acquisition reflects Teva’s strategy of focusing on clinically de-risked assets that are “synergistic” with its broader neurology pipeline, CEO Richard Francis told Endpoints News in an interview. But Jefferies analysts wrote that “IP is unclear, given [ecopipam is] an old drug.” – Ayisha Sharma ⏸️ FDA places clinical hold on Newron’s schizophrenia drug: The decision came after the company flagged the sudden death of a patient enrolled in the Phase 3 ENIGMA-TRS 2 trial outside of the US. Newron said an independent board assessed the event and concluded the study should continue as is. The company added it is working to supply the FDA with the necessary information to get the hold lifted. Evenamide targets voltage-gated sodium channels. Newron has previously touted the drug’s strong safety profile as a potential differentiator from standard-of-care antipsychotics. – Ayisha Sharma Merck has discontinued an anti-CTLA-4 program: Known as MK-1308A, the fixed-dose coformulation included Keytruda plus the anti-CTLA-4 antibody quavonlimab. The treatment was part of Merck’s Litespark-012 study that examined combinations with Lenvima in first-line renal cell carcinoma. Merck announced earlier this month that both the MK-1308A regimen and a separate regimen involving Merck’s Welireg failed. — Lei Lei Wu Leo Pharma buys gene therapy player Replay : The deal is for $50 million upfront, and nets Leo a preclinical HSV-based gene therapy for dystrophic epidermolysis bullosa. Replay launched in 2022 with $55 million in seed funding as a hub-and-spoke gene therapy company. — Lei Lei Wu AstraZeneca gets a new protein degrader: The British pharma will license a bispecific antibody degrader from Pinetree Therapeutics, under a $500 million deal inked back in 2024. The candidate, called PTX-299, targets EGFR and has made “encouraging preclinical progress,” the companies announced on Thursday. The move triggers a $25 million payment to Pinetree, and gives AstraZeneca responsibility for future development and commercialization. — Nicole DeFeudis

并购临床3期IPO临床2期基因疗法

2026-04-30

·FierceBiotech

GSK’s $700M Alector bet blows up as Alzheimer’s drug flunks phase 2

Two GSK-Alector assets have failed key clinical trials in the past six months.\n GSK and Alector have stopped a phase 2 trial of their Alzheimer’s disease drug candidate after an interim analysis found the study was unlikely to hit its primary endpoint. The study randomized 367 people with early Alzheimer’s to receive one of two doses of the anti-sortilin 1 antibody nivisnebart or placebo. GSK and Alector bet that downregulating the sortilin receptor would elevate levels of progranulin, a protein that supports neurons and microglia in the brain, and thereby improve outcomes in Alzheimer’s. However, a futility analysis found the phase 2 study was unlikely to meet its primary endpoint of slowing disease progression at completion. GSK and Alector responded by stopping the trial and working with investigators to get the news to participants.The result effectively ends Alector’s partnership with GSK, TD Cowen analysts said in a note to investors. GSK paid $700 million upfront to partner with Alector in 2021, securing the right to co-develop two drug candidates. Both molecules have failed key clinical trials in the past six months. Latozinemab, another antibody designed to boost progranulin by blocking sortilin, failed a phase 3 trial in frontotemporal dementia last year. TD Cowen analysts said latozinemab’s failure and discontinuation “led to skepticism about the viability of targeting progranulin.” The discontinuation of the phase 2 trial of nivisnebart, a molecule with the same mechanism as latozinemab, was expected, the analysts said.The setbacks follow the failure of Alector’s AbbVie-partnered Alzheimer\'s prospect in 2024. That drug candidate was designed to activate TREM2, a microglial receptor that genetic and preclinical research suggests plays a central role in Alzheimer’s.TREM2 and progranulin are “exciting targets for microglial activation and neuroprotection,” William Blair analysts said in their own note to investors April 29. While the analysts had been “energized” by the scientific rationale, they said central nervous system penetration of the antibody-based agonists in humans remains an open question. A recent presentation of latozinemab data raised the question again, the analysts said.Alector’s next wave of assets uses technology for crossing the blood-brain barrier. The biotech plans to file to test an anti-amyloid beta antibody that uses the technology in humans in the first quarter of next year. TD Cowen analysts said preclinical data on the technology are “initially promising,” but cautioned that clinical data “remain distant.”

临床2期抗体药物偶联物

2026-04-30

·Firstwordpharma

Another miss for GSK, Alector after Phase II Alzheimer's trial halted

Another experimental drug emerging from the partnership between Alector and GSK has fallen short, with the companies pulling the plug on a Phase II Alzheimer's disease trial after an interim analysis found the therapy being tested was unlikely to work. The decision marks the second high-profile failure from the collaboration. Alector said Wednesday that the PROGRESS-AD study of nivisnebart (AL101/GSK4527226) in early Alzheimer's disease will be halted following a pre-specified futility review by an independent monitoring committee. The panel concluded that the anti-sortilin 1 (SORT1) monoclonal antibody was unlikely to meet its primary endpoint of slowing disease progression. The outcome marks the latest setback for the alliance, which was formed in 2021 with a $700-million upfront payment from GSK and the promise of up to $1.5 billion in milestones to co-develop two progranulin-targeting antibodies. The first programme, latozinemab (AL001), failed in a Phase III study in frontotemporal dementia last October, a result that triggered steep layoffs and the resignation of Alector's head of R&D. Alector said it would present full data from PROGRESS-AD at a future medical meeting, but for now the focus shifts to earlier-stage programmes built on its Alector Brain Carrier (ABC) blood-brain barrier delivery platform. "We remain committed to progressing our broader pipeline of programmes targeting neurodegenerative disease, including multiple wholly owned candidates enabled by our ABC platform," said CEO Arnon Rosenthal. The company is advancing its Alzheimer's candidate AL037/AL137 toward an IND filing in early 2027. It says the antibody incorporates ABC with tuned transferrin receptor binding to facilitate brain penetration and plaque removal while minimising haematologic effects. Alector is also developing a gene-silencing platform designed to allow peripheral dosing and potentially more convenient administration compared to the usual intrathecal delivery. Its AL064/AL164 programme targets tau in Alzheimer's and other tauopathies, and is moving towards IND-enabling studies.

100 项与 Nivisnebart 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	临床2期	美国	GSK Plc	2023-10-20
阿尔茨海默症	临床2期	美国	Alector, Inc.	2023-10-20
阿尔茨海默症	临床2期	阿根廷	Alector, Inc.	2023-10-20
阿尔茨海默症	临床2期	阿根廷	GSK Plc	2023-10-20
阿尔茨海默症	临床2期	澳大利亚	GSK Plc	2023-10-20
阿尔茨海默症	临床2期	澳大利亚	Alector, Inc.	2023-10-20
阿尔茨海默症	临床2期	加拿大	GSK Plc	2023-10-20
阿尔茨海默症	临床2期	加拿大	Alector, Inc.	2023-10-20
阿尔茨海默症	临床2期	芬兰	Alector, Inc.	2023-10-20
阿尔茨海默症	临床2期	芬兰	GSK Plc	2023-10-20