Alector Announces First Patient Dosed in PROGRESS-AD Phase 2 Clinical Trial of AL101/GSK4527226 in Patients with Early Alzheimer’s Disease
February 08 2024 - 7:00AM
UK Regulatory
SOUTH SAN FRANCISCO, Calif., Feb. 08, 2024 (GLOBE
NEWSWIRE) -- 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 AL101
AL101 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 GSK
In 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 Alector
Alector 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 Statements
This 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
202-549-0557
katie.hogan@alector.com
1AB (media)
Dan Budwick
973-271-6085
dan@1abmedia.com
Argot Partners (investors)
Laura Perry
Argot Partners
212-600-1902
alector@argotpartners.com
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