Alto Neuroscience Initiates Phase 2 Study of ALTO-101, a Novel PDE4 Inhibitor, in Cognitive Impairment Associated with Schizophrenia
20 Giugno 2024 - 2:05PM
Business Wire
– ALTO-101 has been shown to positively impact
cognition and key cognition-related EEG markers in humans when
delivered orally –
– Novel transdermal formulation of ALTO-101
exhibited favorable pharmacokinetics and tolerability, greater drug
exposure, and fewer PDE4 associated adverse events compared to
ALTO-101 administered orally –
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced
the initiation of a Phase 2 double-blind, placebo-controlled study
of its transdermal formulation of ALTO-101, a novel PDE4 inhibitor
in development for the treatment of cognitive impairment associated
with schizophrenia (CIAS). Alto expects to report top-line data
from the Phase 2 study in the second half of 2025.
“We are excited to initiate our sixth Phase 2 study as a
company, across our pipeline programs, as we continue to redefine
mental healthcare with Alto’s Precision Psychiatry Platform,” said
Amit Etkin, M.D., Ph.D., founder and CEO of Alto Neuroscience.
“Cognitive impairment is disabling in many psychiatric disorders
including schizophrenia, depression, and neurodegenerative
diseases. ALTO-101 has the potential to address the cognitive
aspects of these diseases with a known pro-cognitive mechanism,
while also overcoming the side effects typically associated with
PDE4 inhibitors. We look forward to completing this
proof-of-concept study, as we believe ALTO-101 may benefit patients
with CIAS and potentially become an important therapeutic option
for a broad range of indications.”
Alto recently completed a Phase 1 study of ALTO-101 in healthy
adults, demonstrating positive effects on cognition and
electroencephalography (EEG) measures relevant to cognitive
function. Alto’s novel transdermal formulation of ALTO-101
exhibited greater systemic drug exposure than orally administered
ALTO-101 while also demonstrating a reduction in typical
class-related adverse events.
The Phase 2 study announced today consists of a cross-over
double-blind, placebo-controlled, dose-escalating treatment with
ALTO-101 and placebo in patients with CIAS. Alto expects to enroll
approximately 70 adult participants between 21-55 years old with
schizophrenia and a demonstrable level of cognitive impairment.
Alto will evaluate the effects of ALTO-101 on EEG markers relevant
to cognitive function and will also explore its effects on
cognitive performance. The primary outcome in the study is the
effect of ALTO-101 on theta band activity as measured using EEG at
the end of each dose period.
Alto recently presented data at the Society of Biological
Psychiatry (SOBP) Annual Meeting demonstrating that theta band
activity has both the greatest correlation with cognitive function
in patients with schizophrenia among a comprehensive set of EEG
measures as well as greatest case-control sensitivity. The findings
on these measures, which were prospectively replicated, support the
suitability of the primary outcome measure being evaluated in the
present study to demonstrate robust proof-of-concept of ALTO-101 as
a potential treatment for CIAS.
About ALTO-101
ALTO-101 is a novel small molecule PDE4 inhibitor being
developed for cognitive impairment associated with schizophrenia, a
disease state defined by negative and cognitive symptoms with no
currently available targeted treatments. Through a proprietary
transdermal delivery system, ALTO-101 is designed to provide steady
state concentrations to improve drug safety, tolerability, and
pharmacokinetics. The proprietary transdermal delivery system for
ALTO-101 has been developed in partnership with MEDRx. In Phase 1
clinical trials, ALTO-101 demonstrated human brain penetration,
robust CNS-relevant pharmacodynamic effects, and was well tolerated
across therapeutically relevant dose ranges.
About Cognitive Impairment Associated with
Schizophrenia
Schizophrenia is a serious, persistent, and often disabling
mental illness impacting how a person thinks, feels, and behaves.
The illness affects nearly 24 million people worldwide, including
2.8 million people in the United States. It is characterized by
multiple symptom domains, including: positive symptoms
(hallucinations and delusions), negative symptoms (difficulty
enjoying life and withdrawal from others), and cognitive impairment
(deficits in memory, concentration, and decision-making). A large
proportion of people living with schizophrenia struggle to live
independent lives and often rely on life-long caregiver support.
Approximately 70% of people with schizophrenia have cognitive
impairment associated with the illness, and there are currently no
approved treatments to specifically address the negative and
cognitive symptoms associated with schizophrenia.
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, design, and results of the
ALTO-101 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 design, initiation,
progress and completion of the ALTO-101 study and clinical
development of ALTO-101; the risk that Alto may not achieve the
targeted enrollment in the ALTO-101 study or that enrollment may
take longer than expected; the availability and timing of results
from the ALTO-101 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 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.
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Investor Contact Nick Smith
investors@altoneuroscience.com
Media Contact Jordann Merkert
media@altoneuroscience.com
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