FDA Grants Latozinemab Breakthrough Therapy Designation for Frontotemporal Dementia Due to a Progranulin Gene Mutation (FTD-GRN)
February 07 2024 - 6:00AM
Alector, Inc. (Nasdaq: ALEC) and GSK plc (LSE/NYSE: GSK) today
announced that the U.S. Food and Drug Administration (FDA) has
granted Breakthrough Therapy Designation to latozinemab, an
investigational human monoclonal antibody designed to block
sortilin to elevate progranulin (PGRN) levels for the potential
treatment of frontotemporal dementia with a progranulin gene
mutation (FTD-GRN).
“In partnership with GSK, we are encouraged and excited by this
FDA Breakthrough Designation. FTD-GRN is a rare and rapidly
progressing neurodegenerative disease and one of the most common
causes of early onset dementia," said Arnon Rosenthal, Ph.D., Chief
Executive Officer of Alector. “With this designation, we look
forward to continued productive conversations with the FDA,
recognizing the unmet need for people living with FTD-GRN, a
serious condition for which there are no FDA-approved treatment
options available. Latozinemab, the most advanced
progranulin-elevating candidate in clinical development for
FTD-GRN, is currently being studied in the pivotal INFRONT-3 Phase
3 study, which achieved target enrollment in October 2023.”
The FDA granted latozinemab Breakthrough Therapy Designation for
FTD-GRN based upon data from the INVOKE-2 Phase 2 clinical trial of
latozinemab in FTD-GRN participants. The FDA's Breakthrough Therapy
Designation is granted to expedite the development and review of
drugs in the United States that are intended to treat a serious
condition, when preliminary clinical evidence indicates the drug
may demonstrate substantial improvement over available therapy on a
clinically significant endpoint(s).1
About Latozinemab Latozinemab (AL001) is an
investigational human monoclonal antibody designed to modulate
progranulin (PGRN), a key regulator of immune activity in the brain
with genetic links to multiple neurodegenerative disorders,
including frontotemporal dementia (FTD), Alzheimer’s disease, and
Parkinson’s disease. Latozinemab aims to increase the level of PGRN
in humans by inhibiting sortilin, a degradation receptor for PGRN.
Latozinemab has received Orphan Drug Designation for the treatment
of FTD as well as both Breakthrough Therapy and Fast Track
designations for the treatment of FTD due to a progranulin gene
mutation (FTD-GRN) from the U.S. Food and Drug Administration.
About Frontotemporal Dementia (FTD)
Frontotemporal dementia (FTD) is a rare neurodegenerative disease,
but it is one of the most common causes of early onset dementia..2
It affects an estimated 50,000 to 60,000 people in the United
States and roughly 110,000 in the European Union, with potentially
higher prevalence in Asia and Latin America.3,4 There are multiple
heritable forms of FTD, and FTD patients with a progranulin gene
mutation (FTD-GRN) represent 5% to 10% of all people with FTD.5
Patients with FTD frequently develop symptoms such as behavioral
changes, lapses in judgment, and diminished language skills when
they are in their 40’s and 50’s with the disease running its course
in 7-10 years.6 There are no U.S. Food and Drug
Administration-approved treatment options available for any form of
FTD.2
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
latozinemab and AL101 (GSK4527226). 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, the expectation
regarding the implications of Breakthrough Therapy Designation,
planned and ongoing preclinical studies and clinical trials,
expected milestones, including the timing of data from our
INFRONT-3 trial, and expectations of our collaborations. Such
statements are subject to numerous risks and uncertainties that may
cause actual events or results to differ materially from current
expectations and beliefs, including but not limited to risks and
uncertainties as set forth in Alector’s Annual Reports on Form 10-K
and Quarterly Reports on Form 10-Q, as well as the other documents
Alector files from time to time with the Securities and Exchange
Commission. 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.
REFERENCES
- U.S. Food and Drug Administration (FDA). Breakthrough
Therapy.
- The Association for Frontotemporal Degeneration (AFTD).
- Patient estimates based on internal forecasting analysis using
published literature sources.
- E.U. estimates include EU5 countries only (Spain, Italy,
France, U.K. and Germany).
- FTD Disorders Registry.
- Moore KM, Nicholas J, Grossman M, et al. Lancet Neurol. 2020
Feb; 19 (2).
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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