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
the presentation of new data from its small molecule programs
enhancing the HGF/MET neurotrophic system. The data were presented
in oral and poster presentations at the American Academy of
Neurology (AAN) 2023 Annual Meeting taking place from April 22-27,
2023, in person in Boston, Mass. and virtually.
“We are pleased to report that a post hoc analysis showed
statistically significant improvements in Mini-Mental State Exam
(MMSE) scores in patients treated with fosgonimeton without
concomitant acetylcholinesterase inhibitors (AChEIs) in the
exploratory six month Phase 2 ACT-AD trial,” said Hans J. Moebius,
M.D., Ph.D., Chief Medical Officer, Athira Pharma. “These and other
data presented at this year’s AAN Annual Meeting further support
other previously reported post hoc findings from ACT-AD that showed
improvements in plasma biomarkers and measures of cognition.
Additionally, we reported new data that further elucidate the
interaction between fosgonimeton and AChEIs. Preclinical data
indicate that the neuroprotective effects of fosgonimeton are
reduced in combination with donepezil, and suggest this is due, in
part, to interference in AKT signaling, one of the multimodal
neuroprotective mechanisms enhanced by targeting the HGF/MET
system.”
Kevin Church, Ph.D., Chief Scientific Officer, Athira Pharma,
stated, “We are encouraged by the compelling preclinical evidence
with ATH-1105, which demonstrates statistically significant
improvements on survival and nerve and motor function in an ALS
animal model. We are advancing IND-enabling studies with ATH-1105
and plan to begin clinical evaluation next year.”
“The data presented at AAN 2023 add to our growing body of
evidence and we believe strongly support the therapeutic potential
of enhancing the HGF/MET system with our novel small molecule
product candidates, which are designed to protect and repair
neuronal networks in neurodegenerative diseases,” added Dr.
Church.
Oral presentation (Abstract: 4214, Program:
S26.008): “Fosgonimeton provides congruent improvements on
neurodegeneration biomarkers, significantly correlating with
composite clinical score of cognition and function in Alzheimer’s
disease”
Dr. Moebius presented data from the completed, exploratory six
month Phase 2 ACT-AD trial of fosgonimeton (ATH-1017) in
mild-to-moderate Alzheimer’s disease. Highlights from the oral
presentation showed fosgonimeton treatment without AChEIs:
- Led to a significant improvement in MMSE scores from
baseline (+1.6 pts, p=0.0350);
- Demonstrated a statistically significant decrease in
plasma NfL levels compared with placebo
(-6.48 pg/mL, p=0.0222); and
- Showed consistent and descriptive improvements compared with
placebo across biomarkers of neuroinflammation (GFAP and YKL-40)
and AD-specific protein pathology (Aβ 42/40 ratio and
p-Tau181).
In the full study population, statistically significant
associations were observed between change from baseline (CFB) of a
composite measure of cognition and function and CFB in
neurofilament light chain (NfL, an established biomarker of
neurodegeneration, p=0.0023), and GFAP (a biomarker of
neuroinflammation, p=0.0402).
Oral presentation (Abstract 3944, Program:
S14.008): “Therapeutic Potential
of Fosgonimeton, a Small-Molecule Positive Modulator of
the Neurotrophic HGF/MET Pathway, in Neurodegenerative
Conditions”
Dr. Church reviewed compelling preclinical data that continue to
elucidate fosgonimeton’s multimodal mechanism of action and
therapeutic potential in neurodegenerative diseases, including:
- Neurotrophic effects demonstrated by an increase in
synaptogenesis and neurite length in hippocampal and cortical
neurons, respectively;
- Neuroprotective effects on cortical neurons subjected to
various neurotoxic insults, including oxidative stress,
neuroinflammation, excitotoxicity, and mitochondrial
dysfunction;
- Reduced protein pathology including Aβ-induced p-tau
accumulation in cortical neurons and 6-OHDA–induced α-synuclein
aggregation in dopaminergic neurons; and
- Improved function in several animal models including an
LPS-induced neuroinflammation model of cognitive impairment and a
model of 6-OHDA–induced motor deficits.
Poster presentation (Abstract 3277, Program
P08.007): “Small Molecule Positive Modulator of
Hepatocyte Growth Factor (HGF)/MET, ATH-1105, Improves Function and
Reduces Disease Biomarkers in a TDP-43 Mouse Model of Amyotrophic
Lateral Sclerosis”
Preclinical findings with ATH-1105 demonstrated statistically
significant improvements on nerve and motor function, biomarkers of
inflammation and neurodegeneration, and survival in an animal model
of amyotrophic lateral sclerosis (ALS), including:
- Prolonged survival and delayed time to first mortality
(p=0.0035);
- Improvement in balance, coordination, and muscle strength in
motor function tests (p<0.0001);
- Protection against body weight reduction (p<0.01);
- Preservation of nerve function and structure (p<0.001);
and
- Reduction of plasma biomarkers of systemic inflammation and
neurodegeneration (p<0.0001).
All presentations will be available on the Scientific
Publications & Presentations page of the company’s website at
www.athira.com.
The ACT-AD trial was 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 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 positive modulator of the HGF/MET system. In
preclinical models of amyotrophic lateral sclerosis (ALS), ATH-1105
was shown to significantly improve survival while delayed time to
first death, motor and nerve function, preservation of motor neuron
demyelination and axon degeneration, as well as 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 aims to provide rapid cognitive
improvement and alter the course of neurological diseases with its
novel mechanism of action. Athira is currently 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 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;
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.
Investor & Media ContactJulie RathbunAthira
PharmaJulie.rathbun@athira.com206-769-9219
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