– 300 patients enrolled in the study, including
patients with and without the cognitive biomarker –
– On track to report topline data in October
2024 –
– Alto to host investor day focused on ALTO-100
on September 9, 2024 –
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO), a clinical-stage
biopharmaceutical company focused on the development of novel
precision medicines for neuropsychiatric disorders, today announced
the completion of enrollment in its Phase 2b study of ALTO-100 in
adults with major depressive disorder (MDD). Topline results from
this study are expected to be reported in October 2024.
“The completion of enrollment in this study marks an important
achievement,” said Amit Etkin, M.D., Ph.D., founder and chief
executive officer of Alto Neuroscience. “We look forward to
reporting topline results later this year, which, if positive, will
propel us into Phase 3 and ultimately bring us one step closer to
realizing the potential of precision psychiatry.”
The Phase 2b study is a randomized, double-blind,
placebo-controlled study evaluating ALTO-100 in adults with major
depressive disorder (MDD). The study is designed to determine the
efficacy of ALTO-100 in MDD patients defined by an objective
cognitive biomarker assessed prior to randomization. The Phase 2b
study is enriched for patients exhibiting the predictive cognitive
marker but also includes patients without the marker. The primary
endpoint is the change from baseline to the end of the 6-week
double-blind treatment period on the Montgomery-Åsberg Depression
Rating Scale (MADRS), which is the standard regulatory endpoint in
depression, in the prospectively identified patient population
based on a specific memory deficit. The study was conducted across
34 sites in the U.S. and enrolled 300 adults with MDD. For more
information about the ongoing study, visit ClinicalTrials.gov
(NCT05712187).
“Major depressive disorder is among the most prevalent CNS
conditions and is a leading cause of disability worldwide,” said
Adam Savitz, M.D., Ph.D., chief medical officer of Alto. “If we are
successful, new targeted therapies like ALTO-100 represent the
future of psychiatric care. We are pleased with the receptivity to
our neurocognitive test. The execution of this study demonstrates
the potential for this test to be implemented broadly in clinical
practice. We are grateful to the patients in the study, physicians,
trial site staff, and partnerships with advocacy organizations for
their efforts in helping us to reach this point.”
Alto Investor Day Focused on ALTO-100
in MDD
The company plans to host an investor day on September 9, 2024
focused on ALTO-100. The Company expects to provide information
regarding the baseline characteristics of study participants,
mechanistic and clinical rationale for ALTO-100, and the predictive
cognitive test being used to select patients in the Phase 2b study.
More details regarding the investor day are forthcoming and will be
made available on the Company’s investor relations website.
About ALTO-100
ALTO-100 is a novel oral small molecule that has shown evidence
of a pro-neurogenesis/neuroplasticity mechanism of action and
first-in-class therapeutic potential. ALTO-100 is being developed
for major depressive disorder (MDD). In a Phase 2a clinical trial,
ALTO-100 demonstrated favorable safety and tolerability, and
significantly greater treatment response in patients with an
objectively defined cognitive biomarker.
About the ALTO-100 Cognitive Biomarker
Alto leverages its Precision Psychiatry Platform™ to identify
brain-based biomarkers as predictors of response to medication. The
predictive biomarker identified, and prospectively replicated, for
ALTO-100 is a test of verbal memory, or the ability to recall lists
of unrelated words. Verbal memory is a direct measure of
hippocampal neuroplasticity; therefore, selecting patients based on
poor performance on this test provides a clear biological link
between the proposed pro-plasticity mechanism of ALTO-100 and this
characteristic of responsive patients. The test used to compute the
biomarker score is Alto’s digital adaptation of a well validated
instrument that has been used in clinical practice for assessing
memory for more than 80 years and is highly test-retest reliable.
The web-based memory test is self-administered and can be completed
by the patient in less than 20 minutes in any setting, including at
home. This convenient, reliable, and efficient test enables
high-quality data collection at a broad clinical scale.
About Alto Neuroscience
Alto Neuroscience is a clinical-stage biopharmaceutical company
with a mission to redefine psychiatry by leveraging neurobiology to
develop personalized and highly effective treatment options. Alto’s
Precision Psychiatry Platform™ measures brain biomarkers by
analyzing EEG activity, neurocognitive assessments, wearable data,
and other factors to better identify which patients are more likely
to respond to Alto product candidates. Alto’s clinical-stage
pipeline includes novel drug candidates in depression, PTSD,
schizophrenia, and other mental health conditions. For more
information, visit www.altoneuroscience.com or follow Alto on
X.
Forward Looking Statements
This press release may contain forward-looking statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by words such as “aims,” “anticipates,” “believes,” “could,”
“estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,”
“plans,” “possible,” “potential,” “seeks,” “will” and variations of
these words or similar expressions that are intended to identify
forward-looking statements, although not all forward-looking
statements contain these words. Forward-looking statements in this
press release include, but are not limited to, statements regarding
Alto’s expectations for the timing, progress, and results of the
ALTO-100 study, and the final total number of subjects enrolled in
the study. Actual results or events could differ materially from
the plans, intentions and expectations disclosed in these
forward-looking statements as a result of various factors,
including uncertainties inherent in the timing, progress and
completion of the ALTO-100 study and clinical development of
ALTO-100; the availability and timing of results and other
information from the ALTO-100 study; the success and impact of
Alto’s approach to drug development; and other important factors,
any of which could cause Alto’s actual results to differ from those
contained in the forward-looking statements, which are described in
greater detail in the section titled “Risk Factors” in Alto’s
Quarterly Report on Form 10-Q for the fiscal quarter ended March
31, 2024 filed with the Securities and Exchange Commission (“SEC”)
as well as in other filings Alto may make with the SEC in the
future. Any forward-looking statements contained in this press
release speak only as of the date hereof, and Alto expressly
disclaims any obligation to update any forward-looking statements
contained herein, whether because of any new information, future
events, changed circumstances or otherwise, except as required by
law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240716223697/en/
Investor Contact Nick Smith
investors@altoneuroscience.com
Media Contact Jordann Merkert
media@altoneuroscience.com
Alto Neuroscience (NYSE:ANRO)
過去 株価チャート
から 12 2024 まで 1 2025
Alto Neuroscience (NYSE:ANRO)
過去 株価チャート
から 1 2024 まで 1 2025
