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
findings from the exploratory SHAPE Phase 2 clinical trial to
evaluate fosgonimeton (ATH-1017) in patients with Parkinson’s
disease dementia and dementia with Lewy Bodies.
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.
“In this small exploratory trial, once daily treatment with
fosgonimeton 40 mg showed positive effects in cognitive measures
compared to placebo, with an observed statistically significant
difference in ADAS-Cog13, and numeric positive differences in MMSE
and COWAT over the 6-month double-blind treatment period,” said
Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira. “These
findings support the potential of targeting HGF system positive
modulation as a broadly applicable strategy for treating
neurodegenerative diseases.”
Kevin Church, Ph.D., Chief Scientific Officer of Athira,
commented, “The findings from the cognitive measures in the SHAPE
trial add to the data we have generated from preclinical models of
dementia. Collectively, these preclinical and clinical outcomes
support continued development of our HGF system positive modulators
in diseases with differing pathologies.”
The primary endpoint of SHAPE, a composite score of the change
in Event-Related-Potential (ERP) P300 latency and cognitive
assessment (ADAS-Cog13), was not met compared with placebo.
However, all five patients in the modified intent to treat (mITT)
population treated with fosgonimeton 40 mg once daily saw
improvement in ADAS-Cog13 individually and collectively showed a
statistically significant improvement (-7.2 points at 26 weeks)
compared with placebo (n=7 mITT, p=0.0321). In addition,
directional improvements in other cognitive, functional and
biomarker measurements were observed in the fosgonimeton 40 mg
treatment group. Results for patients in the 70 mg treatment group
were inconsistent, potentially due, in part, to a higher dropout
rate (50%) from baseline enrollment than both the 40 mg (22%) and
placebo (22%) groups.
Fosgonimeton was generally well tolerated, with a favorable
safety profile. There were no treatment-related serious adverse
events or deaths observed in the study. The most common adverse
event in the treatment groups was injection site reactions.
“These encouraging findings from the SHAPE trial further bolster
our confidence in the ongoing Phase 2/3 LIFT-AD trial of
fosgonimeton as a potential treatment for Alzheimer’s disease and
support our May 2023 amendment to the LIFT-AD protocol to pursue
the 40 mg dose versus placebo and discontinue the 70 mg dose. We
expect to complete enrollment of the LIFT-AD trial early in 2024
and to report topline results in the second half of 2024,” said
Mark Litton, Ph.D., President and Chief Executive Officer of
Athira. “More broadly, we are encouraged by the clinical and
preclinical evidence that support the potential therapeutic effects
of HGF system positive modulation across a wide range of
neurodegenerative diseases.”
About SHAPE (NCT04831281)SHAPE was a
randomized, double-blind, placebo-controlled, parallel-group Phase
2 trial for ATH-1017 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 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 or placebo once daily over a treatment course
of 26 weeks. 29% of participants were on background therapy with
acetylcholinesterase inhibitors (AChEIs). The primary endpoint for
SHAPE was change in Event-Related-Potential (ERP) P300 latency, a
functional measure of working memory processing speed, and the
composite Global Statistical Test, which is an unbiased
mathematical algorithm that combines the scores from the cognitive
assessment.
SHAPE results are expected to be presented at an upcoming
medical conference.
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
targeting the neurotrophic HGF system for Alzheimer’s and
Parkinson’s disease, Dementia with Lewy bodies, and amyotrophic
lateral sclerosis. 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
SHAPE trial and their ability to inform and improve future clinical
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 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 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 ContactJulie RathbunAthira
PharmaJulie.rathbun@athira.com 206-769-9219
Athira Pharma (NASDAQ:ATHA)
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