Athira Pharma Completes Enrollment of Phase 2/3 LIFT-AD Clinical Trial of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease
03 Janeiro 2024 - 9:00AM
Athira Pharma, Inc. (NASDAQ: ATHA), a late
clinical-stage biopharmaceutical company focused on developing
small molecules to restore neuronal health and slow
neurodegeneration, today announced completion of enrollment in the
Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential
treatment for mild-to-moderate Alzheimer’s disease.
Fosgonimeton is a potentially first-in-class,
investigational, small molecule designed to positively modulate the
hepatocyte growth factor (HGF) system, which can activate
neuroprotective, neurotrophic and anti-inflammatory pathways in the
central nervous system.
“The successful completion of enrollment in LIFT-AD marks an
important milestone for Athira and enables the topline data readout
in the second half of 2024,” said Mark Litton, Ph.D., President and
Chief Executive Officer of Athira. “We believe LIFT-AD has the
potential to meet the study’s primary endpoint based on the
unblinded interim efficacy and futility analysis performed by an
independent committee on the first 100 patients who completed
the trial. This interim analysis gives us confidence in a
potentially positive outcome for LIFT-AD, as stringent evaluation
criteria were applied based on validated and clinically meaningful
cognitive and functional outcomes.”
“We are also encouraged that more than 85% of participants who
completed the LIFT-AD and ACT-AD clinical trials elected to
participate in the open label extension trial (OLEX). Notably,
there are currently more than 60 patients in this open label trial
who are continuing fosgonimeton treatment beyond 18 months, which
is unexpected in a progressive mild-to-moderate Alzheimer’s disease
population. We also recently reported findings from the exploratory
SHAPE Phase 2 clinical trial, which investigated the use of
fosgonimeton in patients with Parkinson’s disease dementia and
dementia with Lewy Bodies. The results showed positive effects on
several cognitive measures in the fosgonimeton 40 mg dose group,
which is the same dose being investigated in the LIFT-AD trial.
Collectively, the extended duration of OLEX participation and the
SHAPE findings add to our confidence for a positive LIFT-AD outcome
and support the potential of our HGF modulation franchise in
neurodegeneration,” added Dr. Litton.
The Phase 2/3 LIFT-AD clinical trial, which targeted an
enrollment of 298 patients in the primary analysis population,
ultimately enrolled approximately 315 patients with
mild-to-moderate Alzheimer’s disease in a 26-week, randomized,
double-blind, placebo-controlled clinical trial evaluating
once-daily subcutaneous injections of fosgonimeton 40 mg compared
to placebo. The primary endpoint is the Global Statistical Test
(GST), a composite of the co-key secondary endpoints ADAS-Cog11 and
ADCS-ADL23. Key secondary and exploratory endpoints include changes
in plasma biomarkers of neurodegeneration, protein pathology, and
neuroinflammation. Additional information about the LIFT-AD study
can be found at: NCT04488419.
About Athira Pharma, Inc.Athira Pharma, Inc.,
headquartered in the Seattle, Washington area, is a late
clinical-stage biopharmaceutical company focused on developing
small molecules to restore neuronal health and slow
neurodegeneration. Athira aims to alter the course of neurological
disease by advancing its pipeline of therapeutic candidates
targeting the neurotrophic HGF system for Alzheimer’s and
Parkinson’s disease, Dementia with Lewy bodies, and amyotrophic
lateral sclerosis. For more information, visit www.athira.com.
You can also follow Athira on Facebook, LinkedIn and
@athirapharma on X, formerly known
as Twitter, and Instagram.
Forward-Looking StatementsThis communication
contains “forward-looking statements” within the meaning of Section
27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and the Private Securities Litigation Reform
Act of 1995. These forward-looking statements are not based on
historical fact and include statements regarding: product
candidates as a potential treatment for Alzheimer’s disease,
Parkinson’s disease, Parkinson’s disease dementia, Dementia with
Lewy bodies, and other neurodegenerative diseases, such as
amyotrophic lateral sclerosis; future development plans; the
anticipated reporting of data; the potential learnings from the
SHAPE trial and LIFT-AD unblinded interim efficacy and futility
analysis and their ability to inform and improve future clinical
development plans; expectations regarding the potential efficacy
and commercial potential of Athira’s product candidates; and
Athira’s ability to advance its product candidates into later
stages of development. Forward-looking statements generally include
statements that are predictive in nature and depend upon or refer
to future events or conditions, and include words such as “may,”
“will,” “should,” “on track,” “would,” “expect,” “plan,” “believe,”
“intend,” “pursue,” “continue,” “suggest,” “potential,” and other
similar expressions, among others. Any forward-looking statements
are based on management’s current expectations of future events and
are subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to, the data from
preclinical and clinical trials may not support the safety,
efficacy and tolerability of Athira’s product candidates;
development of product candidates may cease or be delayed;
regulatory authorities could object to protocols, amendments and
other submissions; future potential regulatory milestones for
product candidates, including those related to current and planned
clinical studies, may be insufficient to support regulatory
submissions or approval; Athira may not be able to recruit
sufficient patients for its clinical trials; the outcome of legal
proceedings that have been or may in the future be instituted
against Athira, its directors and officers; possible negative
interactions of Athira's product candidates with other treatments;
Athira’s assumptions regarding the sufficiency of its cash, cash
equivalents and investments to fund its planned operations may be
incorrect; adverse conditions in the general domestic and global
economic markets; the impact of competition; regulatory agencies
may be delayed in reviewing, commenting on or approving any of
Athira’s clinical development plans as a result of pandemics or
health epidemics, which could further delay development timelines;
the impact of expanded product development and clinical activities
on operating expenses; the impact of new or changing laws and
regulations; as well as the other risks detailed in Athira’s
filings with the Securities and Exchange Commission from time to
time. These forward-looking statements speak only as of the date
hereof and Athira undertakes no obligation to update
forward-looking statements. Athira may not actually achieve the
plans, intentions, or expectations disclosed in its forward-looking
statements, and you should not place undue reliance on the
forward-looking statements.
Investor & Media Contact:
Julie RathbunAthira
PharmaJulie.rathbun@athira.com206-769-9219
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