Alto Neuroscience Announces Initiation of Phase 2 Study of ALTO-203 in Patients with Major Depressive Disorder
03 Abril 2024 - 6:05AM
Business Wire
Phase 2 study designed to evaluate the
pharmacodynamic effects, pharmacokinetics, and tolerability of
ALTO-203 in patients with major depressive disorder (MDD) and
higher levels of anhedonia
ALTO-203 demonstrated a favorable tolerability
profile across three Phase 1 clinical trials and produced a variety
of emotional and brain effects that support its unique
antidepressant potential
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced
the initiation of its Phase 2 double-blind, single- and
multiple-dose study to determine the pharmacodynamic effects of
ALTO-203 in MDD patients as well as assess its safety,
tolerability, and pharmacokinetics. To date, ALTO-203 has
demonstrated positive emotional and cognitive effects in healthy
participants after a single dose. The present study will evaluate
these effects in patients with MDD to determine the potential of
ALTO-203 as an antidepressant.
“This is the fifth Phase 2 study we have initiated across our
pipeline, a milestone that marks significant progress in our
efforts to redefine mental healthcare through our Precision
Psychiatry Platform,” said Jessica Powell, chief development
officer of Alto Neuroscience. “In a Phase 1 study, ALTO-203
demonstrated an acute increase in positive emotion relative to
placebo and across several dosage levels. We look forward to
completing this proof-of-concept study in patients as we believe
this response may be an important attribute of an antidepressant to
benefit patients with MDD and higher levels of anhedonia
specifically.”
ALTO-203 is a novel small molecule histamine H3 receptor inverse
agonist being developed for the treatment of patients with MDD and
elevated anhedonia, or the lack of motivation or pleasure. This
Phase 2 study consists of two sequential double-blind,
placebo-controlled treatment periods and examines two doses of
ALTO-203 and placebo given as monotherapy in patients with MDD.
The first period uses a randomized single-dose treatment design
to evaluate patient pharmacodynamic responses to ALTO-203 compared
to placebo. The powered primary outcome is measured by an acute
change in positive emotion assessed by the alertness and mood
components of the Bond-Lader Visual Analog Scale (BL-VAS), an
established scale of subjective feelings also used in a prior Phase
1 study of ALTO-203. The second period uses a 28-day, multi-dose
exposure design to assess the safety of ALTO-203 in patients with
MDD. Exploratory, non-powered objectives for the multi-dose period
will evaluate changes in measures of depression, anhedonia, and
other clinical symptoms, along with cognition, EEG, and
wearables.
Alto expects to enroll approximately 60 adult participants with
MDD and evidence of anhedonia, and report topline data from this
study in the first half of 2025. More information about this trial
will be available at ClinicalTrials.gov.
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-203 study, and the number of subjects to be 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 initiation, progress and
completion of the ALTO-203 study and clinical development of
ALTO-203; the risk that Alto may not achieve the targeted
enrollment in the ALTO-203 study or that enrollment may take longer
than expected; the availability and timing of results from the
ALTO-203 study; 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 Annual Report on
Form 10-K for the fiscal year ended December 31, 2023 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.
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Investor Contact Nick Smith
investors@altoneuroscience.com
Media Contact Jordann Merkert
media@altoneuroscience.com
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