Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage
biopharmaceutical company focused on developing small molecules to
restore neuronal health and slow neurodegeneration, presented new
clinical and preclinical data further highlighting the therapeutic
potential of fosgonimeton at the AD/PD™ 2024 International
Conference on Alzheimer’s and Parkinson’s Diseases and Related
Neurological Disorders, being held in Lisbon, Portugal March 5 – 9,
2024.
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.
“Data presented at AD/PD, in tandem with the existing body of
preclinical and clinical evidence, continue to support the
potential of targeting the neurotrophic HGF system to treat
neurodegenerative diseases, including Parkinson’s disease,
Alzheimer’s disease and dementia with Lewy bodies,” said Mark
Litton, Ph.D., President and Chief Executive Officer of Athira. “We
believe safety and efficacy outcomes from the exploratory SHAPE
Phase 2 clinical trial presented at this year’s AD/PD, along with
previous clinical data, support the continued development of
fosgonimeton. The encouraging pro-cognitive effects observed in the
40 mg dose group, assessed for fosgonimeton for the first time in
Parkinson’s disease dementia and dementia with Lewy bodies,
underscore our confidence in the Phase 2/3 LIFT-AD trial, which is
evaluating fosgonimeton at 40 mg as a potential treatment for
mild-to-moderate Alzheimer’s disease, with data expected in the
second half of 2024.”
Athira presented an expanded dataset from the exploratory SHAPE
Phase 2 clinical trial evaluating fosgonimeton in Parkinson’s
disease dementia and dementia with Lewy bodies as a follow up from
data shared in December 2023. While the primary endpoint was not
met by protocoled analysis compared with placebo, as previously
disclosed, the data indicated a favorable safety and tolerability
profile for fosgonimeton in trial participants. In addition,
changes in ADAS-Cog13 observed in the fosgonimeton 40 mg dose arm
were suggestive of a pro-cognitive effect, which was assessed for
fosgonimeton for the first time in these disease states. These
findings support the potential therapeutic benefit of modulating
the neurotrophic HGF system with fosgonimeton for neurodegenerative
diseases.
“We’re pleased to be presenting additional preclinical data
highlighting the neuroprotective effects of fosgonimeton in models
of both Alzheimer’s and Parkinson’s diseases at AD/PD 2024,” said
Kevin Church, Ph.D., Chief Scientific Officer of Athira. “In
Alzheimer’s disease models, key results showed that the
neuroprotective effects of fosgonimeton against glutamate toxicity
in vitro are driven, in part, by activation of pro-survival
signaling pathways that may help to counteract neurodegenerative
hallmarks such as tau pathology and mitochondrial dysfunction.”
Dr. Church continued, “In models of Parkinson’s, the dataset
highlights the ability of fosgonimeton to mitigate pathological
alterations associated with α-synuclein toxicity in vitro and in
vivo. In an aged mouse model of Parkinson’s that included
α-synuclein pathology and GBA1 inhibition, fosgonimeton improved
motor function, promoted dopaminergic neuron survival, and reduced
α-synuclein aggregation. This continued research of fosgonimeton
adds to the body of evidence that positive modulation of the
neurotrophic HGF system is a potential therapeutic approach for
Parkinson’s and other neurodegenerative diseases.”
Presentation Details
Title: Results from SHAPE: A Phase 2 Study of
Fosgonimeton in Patients with Parkinson’s Disease Dementia and
Dementia with Lewy Bodies Abstract Number and Board
Number: #1857; #0465Date/Time: Wednesday,
March 6, 9:00 a.m. WET – Thursday, March 7, 6:00 p.m.
WETPresenter: Hans Moebius, M.D., Ph.D., Senior
Scientific Advisor, Athira Pharma
Title: Neuroprotective Mechanisms of
Fosgonimeton Against Excitotoxicity in Primary Neuron Culture
Abstract Number and Board Number: #1757;
#0209Date/Time: Friday, March 8, 9:00 a.m. WET –
Saturday, March 9, 6:00 p.m. WETPresenter: Sherif
Reda, Ph.D., Associate Director, Discovery Biology, Athira
Pharma
Title: Fosgonimeton protects against
α-synuclein-mediated pathology in preclinical models of Parkinson’s
disease Abstract Number and Board Number: #1243;
#0546Date/Time: Friday, March 8, 9:00 a.m. WET –
Saturday, March 9, 6:00 p.m. WETPresenter: Sharay
Setti, Ph.D., Senior Scientist II, Athira Pharma
The presentations are available on the Scientific Publications
& Presentations page of the company’s website at
www.athira.com.
About FosgonimetonFosgonimeton is a small
molecule designed to enhance the activity of the neurotrophic
hepatocyte growth factor signaling system, an endogenous repair
mechanism for a healthy nervous system. The function of the
neurotrophic HGF system may be impaired in conditions of
neurodegeneration. Targeting the protection and repair of neuronal
networks, fosgonimeton has disease-modifying potential to address a
broad range of neurodegenerative diseases, including Alzheimer’s
disease, Parkinson’s disease, and dementia with Lewy bodies.
About SHAPE (NCT04831281)SHAPE was a
randomized, double-blind, placebo-controlled, parallel-group Phase
2 trial for ATH-1017 (fosgonimeton) in subjects with Parkinson's
disease dementia or dementia with Lewy bodies. The SHAPE trial was
originally designed to enroll approximately 75 individuals, but
Athira elected to end enrollment in October 2022 at 28 subjects due
to subsequently identified study design limitations and a
prioritization of resources toward the LIFT-AD trial in
mild-to-moderate Alzheimer’s disease. Study participants were
randomized across two dose groups and one placebo group on a 1:1:1
basis to receive a subcutaneous injection of ATH-1017
(fosgonimeton) or placebo once daily over a treatment course of 26
weeks. The primary endpoint for SHAPE was a composite score of the
change in Event-Related-Potential (ERP) P300 latency and cognition
(ADAS-Cog13), which was not met by protocoled
analysis.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
diseases by advancing its pipeline of therapeutic candidates that
modulate the neurotrophic HGF system, including fosgonimeton, which
is being evaluated for the potential treatment of mild-to-moderate
Alzheimer’s disease in the Phase 2/3 LIFT-AD trial that is expected
to report topline data in the second half of 2024. For more
information, visit www.athira.com. You can also follow Athira
on Facebook, LinkedIn, 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; future
development plans; the anticipated reporting of data; 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 similar expressions. 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
its financial condition and 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
Athira Pharma (NASDAQ:ATHA)
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