Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage
biopharmaceutical company focused on developing small molecules to
restore neuronal health and slow neurodegeneration, today provided
a clinical pipeline outlook and business update for 2024.
“The new year is off to a strong start with the completion of
enrollment in our Phase 2/3 LIFT-AD clinical trial of fosgonimeton
as a potential treatment for mild-to-moderate Alzheimer’s disease
(AD), which we expect will enable topline data readout from the
study in the second half of 2024,” said Mark Litton, Ph.D.,
President and Chief Executive Officer of Athira. “The potential of
fosgonimeton as a treatment for AD is supported by the independent,
unblinded interim efficacy and futility analysis of the first 100
subjects in the Phase 2/3 LIFT-AD study and the results from the
exploratory Phase 2 ACT-AD clinical trial, which showed potential
congruent improvements in biomarkers of neurodegeneration,
inflammation and Alzheimer’s disease protein pathologies as well as
measures of cognition and function.”
“The totality of data shared to date strengthens our confidence
in and supports the potential of our small molecule approach to
targeting the neurotrophic hepatocyte growth factor (HGF) system
for diseases including Alzheimer’s, Parkinson’s, and amyotrophic
lateral sclerosis (ALS). The consistency of data from preclinical
models across various neurodegenerative diseases and in Alzheimer’s
patients suggests that our small molecule drug candidates may be
neuroprotective, neurotrophic, procognitive and potentially
disease-modifying. This includes our recently reported findings
from the exploratory SHAPE Phase 2 clinical trial, the results of
which 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.”
“We look forward to an exciting year ahead with key preclinical
and clinical milestones on the horizon. Importantly, we continue to
advance and expand our understanding of the potential for
modulating the neurotrophic HGF system and have a strong balance
sheet to support these initiatives through key inflection
points.”
“Finally, I want to thank Dr. Hans Moebius for his considerable
contributions as Athira’s Chief Medical Officer and congratulate
him on his retirement. In addition to his five years with Athira,
Hans has more than 30 years of industry experience and is an
internationally recognized expert in neuropsychiatry, drug research
and development, and regulatory strategy. We look forward to a
continued relationship with Hans in his new role as Senior
Scientific Advisor to Athira,” added Dr. Litton.
Athira’s 2024 Clinical Pipeline Outlook: Status and
Upcoming Milestones
Athira’s drug development pipeline consists of potential
first-in-class (fosgonimeton) and next-generation small molecule
therapeutic candidates (ATH-1105 and ATH-1020) designed to promote
the neurotrophic HGF system, which activates neuroprotective,
neurotrophic and anti-inflammatory pathways in the central nervous
system. Athira’s therapeutic candidates have distinct properties,
which the Company believes may be applicable to a broad range of
neurodegenerative diseases.
Fosgonimeton (ATH-1017) – A
potentially first-in-class, once daily, subcutaneously administered
drug candidate initially targeted for the potential treatment of
Alzheimer’s disease.
LIFT-AD Phase 2/3 clinical trial of fosgonimeton in
mild-to-moderate Alzheimer’s disease
(NCT04488419)
- The LIFT-AD study is investigating the effects of fosgonimeton
40 mg compared with placebo in mild-to-moderate AD patients who are
not receiving background therapy.
- In October 2022, following an unblinded interim efficacy and
futility analysis, an independent data monitoring committee
recommended continuation of the LIFT-AD study in patients with
mild-to-moderate AD who are not receiving background
therapy. The committee also determined that the study
would be well powered to achieve the primary endpoint with
approximately 300 patients given the preliminary effect size
observed in the unblinded interim analysis of approximately 100
patients treated.
- In May 2023, Athira selected the 40 mg dose for further
development and potential regulatory approval.
- In January 2024, Athira announced completion of enrollment in
the LIFT-AD study, ultimately randomizing approximately 315
patients in the primary analysis population.
- The Company expects to report topline data in the second half
of 2024.
Open Label Extension (OLEX) fosgonimeton trial
(NCT04886063)
- Eligible participants who complete the LIFT-AD or ACT-AD trials
and elect to participate in the ongoing OLEX are able to receive up
to 30 months of open-label treatment.
- Greater than 85% of participants who completed either study
have elected to enroll in OLEX to date.
- Currently more than 60 patients are continuing fosgonimeton
treatment beyond 18 months, which is unexpected in a progressive
mild-to-moderate Alzheimer’s disease population.
- Athira believes OLEX will complement its long-term safety
database and provide insights into fosgonimeton’s long-term effects
for up to three years of investigational treatment.
SHAPE Phase 2 clinical trial of fosgonimeton in
mild-to-moderate Parkinson’s disease dementia and Dementia with
Lewy bodies
(NCT04831281)
- In December 2023, Athira announced encouraging results from the
exploratory SHAPE Phase 2 clinical trial of fosgonimeton for the
potential treatment of Parkinson's disease dementia and Dementia
with Lewy bodies.
- Treatment with fosgonimeton 40 mg (n=5) compared to placebo
(n=7) showed positive effects in cognitive measures including
ADAS-Cog13, MMSE, and COWAT over the 6-month double-blind treatment
period.
- The primary endpoint, a composite score of the change in
Event-Related-Potential (ERP) P300 latency and cognitive assessment
(ADAS-Cog13), was not met compared with placebo.
- Fosgonimeton was generally well tolerated, with a favorable
safety profile. There were no treatment-related serious adverse
events observed in the study. The most common adverse event
in the treatment groups was injection site
reactions.
ATH-1105 – A next-generation, orally
administered drug candidate developed for the potential treatment
of amyotrophic lateral sclerosis as the Company’s initial
indication.
- ATH-1105’s potential as a treatment for ALS is supported by a
growing body of preclinical evidence demonstrating statistically
significant improvements on nerve and motor function, biomarkers of
inflammation and neurodegeneration, and survival in various ALS
animal models.
- These data were presented throughout 2023 at a variety of key
scientific and medical meetings including the American Association
of Neurology (AAN), the Alzheimer’s Association International
Congress (AAIC), the Northeast Amyotrophic Lateral Sclerosis
Consortium® (NEALS), and the Motor Neurone Disease Association
(MNDA).
- The initiation of first-in-human studies of ATH-1105 is
targeted for the first half of 2024 to evaluate this promising drug
candidate as a treatment for ALS.
Management Team UpdateHans Moebius, MD, PhD, is
retiring as Chief Medical Officer effective January 5, 2024, and
will continue as Athira’s Senior Scientific Advisor. The Company
has initiated a search to fill the Chief Medical Officer
position.
Financial Position Athira has unaudited
cash, cash equivalents and investments of approximately $147.4
million as of December 31, 2023, to support the advancement of the
Company’s innovative pipeline through key inflection points.
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. 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, such as
amyotrophic lateral sclerosis; future development plans; the
anticipated reporting of data; the potential learnings from the
ACT-AD and SHAPE trials 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;
preliminary and unaudited estimates of Athira’s cash, cash
equivalents, and investments; 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. Furthermore, Athira is in the process
of finalizing its financial results for the fourth quarter and
fiscal year ended December 31, 2023, and therefore such finalized
and audited results and final analysis of those results are not yet
available. The preliminary expectations regarding year-end cash,
cash equivalents, and investments are the responsibility of
management, are subject to management’s review, and actual results
could differ from management’s expectations. The actual results are
also subject to audit by Athira’s independent registered public
accounting firm and no assurance is given by its independent
registered public accounting firm on such preliminary expectations.
No conclusions should be made as to any other financial results as
of and for the year ended December 31, 2023, based on the foregoing
estimates.
Investor & Media Contact:
Julie RathbunAthira
PharmaJulie.rathbun@athira.com206-769-9219
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