Alector Announces First Patient Dosed in PROGRESS-AD Phase 2 Clinical Trial of AL101/GSK4527226 in Patients with Early Alzheimer’s Disease
08 Février 2024 - 1:00PM
Alector, Inc. (Nasdaq: ALEC) and GSK plc (LSE/NYSE: GSK) 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. Alector
and GSK are co-developing and will be co-commercializing AL101 for
the potential treatment of more prevalent neurodegenerative
diseases, including AD and Parkinson’s disease.
“In partnership with GSK, we are delighted to announce the
dosing of the first patient in PROGRESS-AD, the Phase 2 trial of
AL101 for the treatment of early Alzheimer’s disease, which remains
a high unmet need,” said Arnon Rosenthal, Ph.D., Chief Executive
Officer of Alector. “Modest reduction in the levels of progranulin
due to genetic mutations has been shown to be associated with an
increased risk of developing Alzheimer’s disease. Conversely, an
elevation of progranulin was shown to be protective in animal
models of Alzheimer’s disease. This provides a genetic and
biological rationale for considering the investigational testing of
AL101 in Alzheimer’s disease. To date, AL101 has been shown to be
generally well tolerated and elevated progranulin levels in healthy
volunteers. We look forward to continuing the development of AL101
in this Phase 2 trial with our partner GSK who is operationalizing
the trial. AL101 is an exciting addition to our expanding portfolio
of investigational dementia therapies, which includes the
TREM2-activating antibody AL002, currently in the final stages of a
Phase 2 trial in Alzheimer’s disease, and latozinemab, a
progranulin-elevating antibody, advancing through the final stages
of a pivotal Phase 3 trial in frontotemporal dementia due to a
progranulin gene mutation.”
PROGRESS-AD is a randomized, double-blind, placebo-controlled
Phase 2 clinical trial of AL101 enrolling approximately 282
patients with early Alzheimer’s disease at multiple sites globally.
The 76-week study is designed to assess the safety and
efficacy of two dose levels of AL101 compared to placebo.
Participants will be randomized to one of three treatment groups,
receiving AL101 or placebo intravenously. The primary endpoint of
the study is disease progression as measured by the Clinical
Dementia Rating Sum of Boxes (CDR®-SB). The CDR-SB is a validated
instrument that tracks the progression of cognitive impairments in
various categories. The trial also employs other clinical and
functional outcome assessments.
The Phase 1 study of AL101 was a randomized, double-blind,
placebo-controlled study in 88 healthy volunteers who received
either single or multiple doses of AL101 administered intravenously
(IV) or subcutaneously (SC). The study found that AL101 was
generally well tolerated and increased progranulin (PGRN)
levels in plasma and cerebrospinal fluid (CSF) in a dose-dependent
manner. The study results demonstrated that the PK and PD profile
supported the progression to Phase 2 clinical trials for more
prevalent neurodegenerative conditions, such as AD
and Parkinson’s disease.
Additional information about PROGRESS-AD (NCT06079190) may be
found at ClinicalTrials.gov.
About AL101AL101 is an
investigational human monoclonal antibody designed to elevate the
level of progranulin, a regulator of immune activity in the brain
with genetic links to multiple neurodegenerative disorders.
Mutations that moderately reduce the expression levels of
progranulin have been shown to increase the risk of developing
Alzheimer’s disease and Parkinson’s disease. Increased progranulin
levels have been demonstrated to be protective for these diseases
in animal models.
Collaboration with GSKIn July
2021, Alector entered into a collaboration and license agreement
with GSK (NYSE: GSK) to collaborate on the global development and
commercialization of progranulin-elevating monoclonal antibodies,
including investigational candidates latozinemab and AL101 for a
range of neurodegenerative diseases, including frontotemporal
dementia, amyotrophic lateral sclerosis, Alzheimer’s disease, and
Parkinson’s disease. Under the terms of the GSK agreement, Alector
received $700 million in upfront payments. In addition, Alector may
be eligible to receive up to an additional $1.5 billion in clinical
development, regulatory, and commercial launch-related milestone
payments. In the United States, the companies will equally share
profits and losses from commercialization of latozinemab and AL101.
Outside of the United States, Alector will be eligible for
double-digit tiered royalties.
About AlectorAlector is a
clinical-stage biotechnology company pioneering immuno-neurology, a
novel therapeutic approach for the treatment of neurodegenerative
diseases. Immuno-neurology targets immune dysfunction as a root
cause of multiple pathologies that are drivers of degenerative
brain disorders. Alector has discovered and is developing a broad
portfolio of innate immune system programs, designed to
functionally repair genetic mutations that cause dysfunction of the
brain’s immune system and enable rejuvenated immune cells to
counteract emerging brain pathologies. Alector’s immuno-neurology
product candidates are supported by biomarkers and seek to treat
indications, including Alzheimer’s disease and genetically defined
frontotemporal dementia patient populations. Alector is
headquartered in South San Francisco, California. For additional
information, please visit www.alector.com.
About GSK GSK is a global
biopharma company with a purpose to unite science, technology, and
talent to get ahead of disease together. Find out more at
gsk.com.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements in this press release include, but are
not limited to, statements regarding our product candidates, our
and our investigators' judgments and beliefs regarding the observed
safety and efficacy to date of our product candidates, planned and
ongoing preclinical studies and clinical trials, expected
milestones, including the timing of data from the PROGRESS-AD Phase
2 trial, and expectations of our collaborations. Such statements
are subject to numerous risks and uncertainties, including but not
limited to risks and uncertainties as set forth in Alector’s
Quarterly Report on Form 10-Q filed on November 7, 2023, with the
Securities and Exchange Commission (“SEC”), as well as the other
documents Alector files from time to time with the SEC. These
documents contain and identify important factors that could cause
the actual results for Alector to differ materially from those
contained in Alector’s forward-looking statements. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Alector specifically disclaims any
obligation to update any forward-looking statement, except as
required by law.
Alector Contacts:
Alector Katie Hogan 202-549-0557katie.hogan@alector.com
1AB (media)Dan Budwick973-271-6085 dan@1abmedia.com
Argot Partners (investors)Laura Perry Argot
Partners212-600-1902alector@argotpartners.com
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