Alector Presents Results from First-in-Human Phase 1 Study of AL101 for the Treatment of Neurodegenerative Diseases
30 November 2022 - 3:05AM
Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology and innate immuno-oncology,
reported safety and biomarker data from a first-in-human Phase 1
healthy volunteer study of AL101, a human monoclonal antibody that
blocks the sortilin receptor to increase progranulin levels. 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), under Alector’s collaboration with GSK.
In a randomized, double-blind, placebo-controlled Phase 1 study
in 88 heathy volunteers who received either single or multiple
doses of AL101 administered intravenously (IV) or subcutaneously
(SC), AL101 was generally well tolerated and elevated PGRN levels
in the cerebrospinal fluid (CSF). The study results that will be
presented today from the multiple-dose (MD) cohorts demonstrated
that the product candidate’s pharmacokinetic (PK) and
pharmacodynamic (PD) profile supports development in multiple
dosing schedules for chronic neurodegenerative conditions, such as
AD and PD.
“Phase 1 study results demonstrated that AL101 elevated
progranulin levels, and these results pave the way for exploring
multiple indications and dosing schedules for AL101,” said Gary
Romano, M.D., Ph.D., Chief Medical Officer of Alector. “Human
genetics have shown that even moderately reduced progranulin
expression may lead to an increased risk of developing
neurodegenerative disorders, such as Alzheimer’s disease and
Parkinson’s disease. We are excited to have the opportunity to test
the hypothesis that increasing progranulin in the brain of patients
suffering from these diseases may counteract disease
pathology.”
New Dosing Data from Phase 1 Study of AL101The
data that will be presented at CTAD 2022 from the multiple-dose
(MD) cohorts of the Phase 1 study build upon previous data reported
at CTAD 2021 from the single-dose (SD) cohorts, which demonstrated
that AL101 was well tolerated and increased PGRN levels in plasma
and CSF in a dose-dependent manner. In the two MD cohorts, 27
healthy volunteers received either AL101 30 mg/kg IV every four
weeks (q4w) for a total of four doses [n=11] or AL101 300 mg SC
every two weeks (q2w) for a total of seven doses [n=13]. Three
volunteers received MD IV placebo. Key highlights from the study
include the following:
- AL101 was found to be generally well tolerated following MD IV
(q4w) and SC (q2w) administrations.
- Consistent with previously presented data following single
doses, AL101 was measurable in the CSF following multiple IV and SC
doses.
- 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 and approximately 80% (1.8-fold) above
baseline in the CSF.
- The PK and PD profile of AL101 following single and multiple IV
doses support future development in chronic neurodegenerative
conditions such as AD and PD.
Additional details will be presented during the poster
presentation at CTAD 2022 and can be found in the published poster
and abstract. The poster is available on the CTAD 2022 digital
platform, www.ctad-alzheimer.com. The abstract will be available on
the digital platform on December 2, 2022, at 5pm Pacific
Standard Time (PST).
Poster Presentation DetailsPoster
Number: P040Title: Repeat IV and SC
Dosing of the Anti-Sortilin Antibody AL101Date &
Time: Tuesday, November 29 at 4pm PST to Wednesday,
November 30 at 6pm PSTLocation: Onsite at CTAD
2022
About AL101
AL101 is a human monoclonal antibody designed to elevate the
level of progranulin1, 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.
AL101 received orphan drug designation from the U.S. Food and
Drug Administration for the treatment of frontotemporal dementia in
July 2019. In July 2021, Alector and GSK announced a global
collaboration to co-develop and co-commercialize two
progranulin-elevating candidates, latozinemab (AL001) and AL101,
for a range of neurodegenerative diseases, including frontotemporal
dementia, amyotrophic lateral sclerosis, Alzheimer’s disease, and
Parkinson’s disease.
About Alector
Alector is a clinical-stage biotechnology company pioneering
immuno-neurology, a novel therapeutic approach for the treatment of
neurodegenerative diseases, and innate immuno-oncology.
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 target
genetically defined patient populations in frontotemporal dementia
and Alzheimer’s disease. This scientific approach is also the basis
for the company’s innate immuno-oncology programs. Alector is
headquartered in South San Francisco, California. For additional
information, please visit www.alector.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 business plans,
business strategy, product candidates, planned preclinical studies,
clinical trials, expected milestones, expectations of our
collaborations, and financial and cash guidance. 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, as filed on November 8, 2022, 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:
1AB (media)Dan Budwick973-271-6085dan@1abmedia.com
Argot Partners (investors)Laura Perry/Carrie McKimArgot
Partners212.600.1902alector@argotpartners.com
1 Ward, M., Yeh, F., Park, L., et al., 2022, November.
Repeat IV and SC Dosing of the Anti-Sortilin Antibody AL101. 15th
Clinical Trials on Alzheimer’s Disease (CTAD), San Francisco.
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