Athira Pharma Completes First Cohort in Phase 1 Clinical Trial of ATH-1105, an Oral, Small Molecule Drug Candidate for Amyotrophic Lateral Sclerosis (ALS)
June 11 2024 - 7:00AM
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
that it has completed the first cohort of healthy volunteers in its
ongoing, first-in-human, dose escalation Phase 1 clinical study
evaluating ATH-1105, an oral, small molecule positive modulator of
the neurotrophic hepatocyte growth factor (HGF) system in
development for the treatment of amyotrophic lateral sclerosis
(ALS).
“We are particularly excited about the potential for ATH-1105 as
a treatment for ALS based on our compelling preclinical data that
have shown ATH-1105 can improve motor function, preserve nerve
health and structure, and prolong survival in a mouse model of
ALS,” said Javier San Martin, M.D., Chief Medical Officer of
Athira. “We look forward to continued development of this promising
therapeutic candidate for people with ALS, who are in need of
therapies that improve the course of disease.”
“We are pleased to start this Phase 1 clinical trial and we are
eager to explore the potential of ATH-1105 in ALS patients, which
we are targeting to initiate in 2025,” said Mark Litton, Ph.D.,
President and Chief Executive Officer of Athira. “Our robust
preclinical data to date have demonstrated ATH-1105's
neuroprotective effects including a consistent reduction in plasma
neurofilament light chain (NfL) levels, an established biomarker of
neurodegeneration in ALS. By modulating the neurotrophic HGF
system, we believe we can prevent or slow the progressive decline
of motor and nerve function, reduce inflammation, preserve body
weight and extend survival for patients suffering with this
devastating neurodegenerative condition that has few treatment
options.”
The Phase 1 (NCT 06432647) double-blind, placebo-controlled
trial will enroll up to 80 healthy volunteers and evaluate single
and multiple oral ascending doses. The study will evaluate the
safety and tolerability of ATH-1105 and will include measurement of
pharmacokinetic outcomes. Completion is expected by year-end
2024.
About ATH-1105ATH-1105 is a next-generation,
orally administered, small molecule drug candidate in development
for the potential treatment of ALS. In preclinical models of ALS,
ATH-1105 has been shown to significantly increase survival, enhance
motor and nerve function, reduce peripheral nerve demyelination and
axon degeneration, and improve 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 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 Statements This 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: Athira’s drug
candidates as a potential treatment for amyotrophic lateral
sclerosis, Alzheimer’s disease, and other neurodegenerative
diseases; future development plans; the anticipated reporting of
data; the potential learnings from preclinical studies and other
nonclinical data and their ability to inform and improve future
clinical development plans; expectations regarding the potential
efficacy and commercial potential of Athira’s drug candidates; and
Athira’s ability to advance its drug 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 drug candidates; development
of drug candidates may cease or be delayed; regulatory authorities
could object to protocols, amendments and other submissions; future
potential regulatory milestones for drug 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 drug
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; the impact of expanded
drug candidate 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 Contacts:Julie RathbunAthira
PharmaJulie.rathbun@athira.com 206-769-9219
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