Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage
biopharmaceutical company focused on developing small molecules to
restore neuronal health and slow neurodegeneration, is presenting
new data supporting its pipeline of small molecule therapeutic
candidates designed to enhance the HGF/MET neurotrophic system. The
data are being presented in three poster presentations at the
Alzheimer’s Association International Conference (AAIC) 2023,
taking place July 16 – 20, 2023, virtually and in Amsterdam,
Netherlands.
“These findings underscore the potential clinical utility of
biomarkers of neurodegeneration and neuroinflammation in
Alzheimer's disease, and help elucidate the neuroprotective
mechanisms of this promising product candidate,” said Hans J.
Moebius, M.D., Ph.D., Chief Medical Officer of Athira Pharma. “Even
with the recent advancements in Alzheimer’s disease drug
development, there remains significant need for treatments that can
rescue cells from neurodegeneration to aid in preserving and
protecting the memories and independence of people living with this
progressive disease. Additional new preclinical data being
presented at AAIC 2023 suggest that fosgonimeton treatment protects
neurons by attenuating the toxic effects of amyloid-beta, including
reduction of p-Tau levels, which may be driven by recovery of
mediators of autophagy.”
Kevin Church, Ph.D., Chief Scientific Officer, Athira Pharma,
commented, “We are encouraged by the growing body of preclinical
research supporting ATH-1105, which shows that the molecule is
protective against several pathologies common to ALS and FTD animal
models. The consistency and breadth of these effects in reducing
markers of inflammation, neurodegeneration, and TPD-43 protein
pathology continue to support the broad therapeutic potential and
continued advancement of ATH-1105.”
Poster Presentation (Poster 80009; Session
P4-06): “Biomarker analyses from the phase 2, randomized,
placebo-controlled ACT-AD and open-label extension clinical trials
of fosgonimeton in patients with mild-to-moderate Alzheimer’s
disease”
Dr. Moebius is presenting data suggesting that improvements in
plasma biomarkers of neurodegeneration (neurofilament light chain
or NfL) and neuroinflammation (glial fibrillary acidic protein, or
GFAP) correlate with improvements of clinical measures of cognition
and function in patients with mild-to-moderate Alzheimer’s
disease.
- This was a post-hoc analysis of the randomized,
placebo-controlled Phase 2 ACT-AD study and data from the
open-label extension study in patients with mild-to-moderate
Alzheimer’s disease.
- Change from baseline in NfL and GFAP concentrations both
significantly correlated with improvements in ADAS-Cog11
(Alzheimer’s Disease Assessment Scale–Cognitive Subscale).
- Further, change from the double-blind period baseline in NfL
concentrations significantly correlated with improvements in MMSE
(Mini-Mental State Examination) scores at the transition to the
open label extension study. Change from baseline in GFAP trended
toward correlation with improvements in MMSE scores.
- NfL and GFAP improvements significantly correlate with a
composite score of cognition and function, further supporting the
clinical utility of these biomarkers.
Poster Presentation (Poster 79759; Session
P2-05): “Fosgonimeton, a small-molecule positive modulator of the
HGF/MET system, attenuates amyloid-beta-mediated toxicity in
primary neuron cultures”
Sherif Reda, Ph.D., Associate Director, Discovery Biology,
Athira Pharma, is presenting a preclinical study demonstrating that
fosgonimeton attenuates amyloid-ß-mediated toxicity in vitro.
- Treatment with fosgonimeton reduced tau phosphorylation and
protected cultured cortical neurons from amyloid-ß-induced
degeneration.
- Fosgonimeton drove pro-survival signaling cascades that under
the conditions tested counteracted protein pathology, apoptotic
signaling, oxidative stress and autophagy impairment.
- Results highlight fosgonimeton’s potential as a therapeutic
candidate to slow disease progression and restore neuronal
health.
Poster Presentation (Poster 80041; Session
P4-05): “ATH-1105, a small-molecule positive modulator of the
HGF/MET system, is neuroprotective and attenuates TDP-43 protein
pathology in ALS and frontotemporal dementia-relevant preclinical
models”
Jewel Johnson, Ph.D., Director, In Vivo Pharmacology, Athira
Pharma, is presenting findings in preclinical models demonstrating
that ATH-1105 offers protection against several pathologies common
to ALS and FTD, supporting its strong therapeutic potential and
continued development in these indications. The data showed that
treatment with ATH-1105:
- Reduced markers of inflammation, neurodegeneration, and TDP-43
pathology in a mouse model of ALS and FTD;
- Attenuated LPS-induced cognitive impairment in vivo;
- Enhanced neurite outgrowth and synaptogenesis in primary rat
hippocampal neurons;
- Protected against neurotoxic injury in primary rat cortical
neurons; and
- Mitigated lipopolysaccharide (LPS)-stimulated cytokine release
of THP-1 macrophages.
All presentations will be available on the Scientific
Publications & Presentations page of the company’s website
at www.athira.com.
The ACT-AD trial and the related open-label extension for ACT-AD
participants were supported by a grant from the National Institute
on Aging of the National Institutes of Health under Award Number
R01AG06268. The information presented in this press release is
solely the responsibility of Athira Pharma and does not necessarily
represent the official views of the National Institutes of
Health.
About FosgonimetonFosgonimeton is a small
molecule designed to enhance the activity of hepatocyte growth
factor (HGF) and its receptor, MET, an endogenous repair mechanism
for a healthy nervous system. The function of the HGF/MET
neurotrophic 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 ATH-1105ATH-1105 is an orally available
small molecule designed to positively modulate the HGF/MET system.
In preclinical models of amyotrophic lateral sclerosis (ALS),
ATH-1105 was shown to significantly increase survival and delay
time to first death, enhance motor and nerve function, reduce motor
neuron demyelination and axon degeneration, and improve biomarkers
of neurodegeneration and inflammation.
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 Pharma aims to alter the course of
neurological diseases by advancing its pipeline of therapeutic
candidates targeting the HGF/MET neurotrophic system for
Alzheimer’s and Parkinson’s disease, Dementia with Lewy bodies, and
amyotrophic lateral sclerosis (ALS). For more information,
visit www.athira.com. You can also follow Athira Pharma
on Facebook, LinkedIn and @athirapharma
on 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, Dementia with Lewy bodies, and other
neurodegenerative diseases, such as amyotrophic lateral sclerosis
and frontotemporal dementia; Athira’s platform technology and
potential therapies; future 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 for our
product candidates from our preclinical and clinical trials not
supporting the safety, efficacy and tolerability of our product
candidates; cessation or delay of Athira’s development of product
candidates may occur; 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; the
impact of the COVID-19 pandemic on Athira’s business, research and
clinical development plans and timelines, and the regulatory
process for Athira product candidates; 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 us and certain of our directors and officers; clinical
trials may not demonstrate safety and efficacy of any of Athira’s
product candidates; 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 the COVID-19 pandemic,
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. 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.
Media ContactJanine BogrisEvoke Canale for
Athira PharmaJanine.bogris@canalecomm.com201-245-6838
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