– Breadth of Alto’s pipeline and Precision
Psychiatry Platform™ will be highlighted across twelve posters and
presentations at the Society of Biological Psychiatry and American
Society of Clinical Psychopharmacology Annual Meetings –
– Presented comprehensive identification and
prospective replication of neurobiological markers linked to
cognitive impairment associated with schizophrenia; Results inform
design of planned ALTO-101 proof-of-concept study in CIAS –
– Importance of developing ALTO-100 in
depression characterized by poor cognition highlighted through new
analyses demonstrating baseline cognition does not moderate
response for vortioxetine and poor cognition in turn drives
functional impairment in depression –
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced
upcoming data presentations that highlight the company’s precision
psychiatry pipeline and biomarker-based analyses at the Society of
Biological Psychiatry (SOBP) and American Society of Clinical
Psychopharmacology (ASCP) Annual Meetings, to take place May 9-11
in Austin, TX, and May 28-31 in Miami Beach, FL, respectively.
“The vast amount of clinical and biomarker data we’ve generated
to date enables our team to make important contributions to the
scientific community and develop novel compounds for patients in
need, in both depression and schizophrenia,” said Amit Etkin, M.D.,
Ph.D., founder and chief executive officer of Alto Neuroscience.
“Alto’s precision psychiatry platform continues to get stronger
with each new dataset we analyze. Importantly, we have
systematically identified and prospectively replicated
neurobiological markers linked to cognitive impairment associated
with schizophrenia in a comprehensive analysis inclusive of all
major candidate biomarkers. Our rigorous data science approach
derives its impact from prospectively validating important
discoveries. In this case, doing so enables us to identify the most
pertinent and consistent signals to use as primary outcome measures
for proof-of-concept studies – with theta response as a notable
example of this in the planned ALTO-101 study.”
Summary of Data Presentations Across Clinical Programs
ALTO-100:
- Data from the completed Phase 2a study highlight the
identification, and prospective replication, of a memory-based
cognitive marker predicting greater antidepressant response to
ALTO-100.
- New analysis of vortioxetine Phase 3 data demonstrates that
baseline cognitive performance is not a moderator of response to
vortioxetine. Vortioxetine does not show greater benefit in
patients with poor baseline cognitive performance despite its
reported benefits for aspects of cognition.
- New analysis of a large depression trial demonstrates that poor
memory predicts worse functional outcomes in depression – further
highlighting the need for better treatment options for this
underserved population.
ALTO-101:
- Data from a completed randomized, double-blind,
placebo-controlled Phase 1 study in healthy adult volunteers
demonstrate significant effects of ALTO-101 on electrophysiological
measures relevant to cognitive processing, including theta
response, as well as information processing speed, an important
area of cognitive impairment associated with schizophrenia.
- A new analysis of the Bipolar and Schizophrenia Network for
Intermediate Phenotypes (BSNIP) studies identified, and
prospectively replicated, theta response as the EEG marker best
linked to schizophrenia diagnosis and cognitive impairment in
patients. A notable relationship between theta response and
processing speed, which is thought to underpin cognitive impairment
in schizophrenia, was observed.
ALTO-300:
- Data from the completed Phase 2a study highlight the
identification, and prospective replication, of an EEG-based
cognitive marker predicting greater response to ALTO-300.
The details of each presentation follow:
Society of Biological Psychiatry Annual Meeting
Thursday, May 9, 2024 Poster Session I: 5:30-7:30 p.m. CT,
Griffin Hall
- Presentation Title: Identification and Prospective
Replication of a Cognitive Biomarker for Predicting the
Antidepressant Effect of ALTO-100, a Novel Pro-plasticity Drug
Candidate, in Patients with Major Depression: Results from a Large
Phase 2a Study
- Poster Authors: Joshua T. Jordan, Ph.D., Nicholas J.
Cooper, Ph.D., Faizan Badami, M.S., Jessica Powell, Wei Wu, Ph.D.,
Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D.
- Presentation Title: Identification and Prospective
Replication of Electrophysiological Markers Linked to Cognitive
Impairment in Schizophrenia
- Poster Authors: Chao Wang, Ph.D., Sam Goncalves, M.S.,
Joshua T. Jordan, Ph.D., Maimon Rose, Ph.D., Akshay Sujatha
Ravindran, Ph.D., Mike Avissar, M.D., Ph.D., Greg Hajcak, Ph.D.,
Faizan Badami, M.S., Yueqi Guo, Ph.D., Wei Wu, Ph.D., Jessica
Powell, Amit Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D.
- Presentation Title: Verbal Memory and Inhibitory Control
Predict Functional Capacity in Major Depressive Disorder: A
Secondary Analysis of the ReMIND SWITCH Trial
- Poster Authors: Joshua T. Jordan, Ph.D, Li Shen, Ph.D,
Wei Wu, Ph.D., Adam J. Savitz, M.D., Ph.D., Amit Etkin, M.D.,
Ph.D.
Friday, May 10, 2024 Concurrent Symposia: 4:00-6:00 p.m. CT, JW
Grand Ballroom 2
- Session Title: Bringing Precision Psychiatry out of the
Lab and Into the Clinic: Developing Biomarkers for Diagnosis, Drug
Development, Treatment Selection and Tracking Clinical Status
- Speakers: Amit Etkin, M.D., Ph.D., founder and CEO of
Alto will serve as Chair, and Adam Savitz, M.D., Ph.D., CMO of
Alto, will serve as Co-chair of the session. Additional presenters
include Daniel Mathalon, M.D., Ph.D., University of California, San
Francisco; Magali Haas, M.D., Ph.D., Cohen Veterans Bioscience;
Katharine Dunlop, Ph.D., University of Toronto
- Dr. Etkin will present from 5:25-5:50 p.m. CT: Development and
Prospective Replication of Biomarkers for Predicting Treatment
Outcome With ALTO-100 and ALTO-300 in Major Depression: Data from
Multiple Phase 2 Programs. Dr. Savitz will serve as a discussant
for the panel.
Poster Session II: 6:00-8:00 p.m. CT, Griffin Hall
- Presentation Title: Identification and Prospective
Replication of an EEG Biomarker for Predicting the Antidepressant
Effect of ALTO-300 in Patients with Major Depression: Results from
a Large Phase 2a Study
- Poster Authors: Maimon Rose, Ph.D., Joshua T. Jordan,
Ph.D., Chao Wang, Ph.D., Faizan Badami, M.S., Jessica Powell, Fadi
Abdel, M.D., Wei Wu, Ph.D., Amit Etkin, M.D., Ph.D., Adam J.
Savitz, M.D., Ph.D.
- Presentation Title: Baseline Cognition is Not Associated
with Depression Outcomes with Vortioxetine for Major Depressive
Disorder: Findings from Placebo-Controlled Trials
- Poster Authors: Joshua T. Jordan, Ph.D., Li Shen, Ph.D.,
Nicholas J. Cooper, Ph.D., Samantha V. Goncalves, M.S., Madhukar H.
Trivedi, M.D., Alan F. Schatzberg, M.D., Wei Wu, Ph.D., Adam J.
Savitz, M.D., Ph.D., & Amit Etkin, M.D., Ph.D.
Saturday, May 11, 2024 Poster Session III: 5:00-7:00 p.m. CT,
Griffin Hall
- Presentation Title: Identification of
Brain/Behavior-based Pro-cognitive Pharmacodynamic Effects for
ALTO-101 in Healthy Volunteers: Results from a Randomized,
Double-blind Phase 1 Study
- Poster Authors: Akshay Ravindran, Ph.D., Guhan Sundar,
Samantha Goncalves, M.S., Chao Wang, Ph.D., Li Shen, Maimon Rose,
Ph.D., Joshua T. Jordan, Ph.D., Nicholas J. Cooper, Ph.D.,
Sebastian Marquez, Ph.D., Faizan Badami, M.S., Wei Wu, Ph.D., Amit
Etkin, M.D., Ph.D., Adam J. Savitz, M.D., Ph.D.
American Society of Clinical Psychopharmacology Annual
Meeting
Tuesday, May 28, 2024 Pharmaceutical Pipeline Session: 2:00-4:00
p.m. ET, Salon 3
- Presentation Title: Pro-cognitive Pharmacodynamic
Effects of ALTO-101: Results from Brain and Behavioral Outcomes in
a Randomized, Double-blind Phase 1 Study
- Poster Authors: Akshay Ravindran, Ph.D., Guhan Sundar,
Samantha Goncalves, M.S., Chao Wang, Ph.D., Li Shen, Ph.D., Maimon
Rose, Ph.D., Joshua T. Jordan, Ph.D., Nicholas J. Cooper, Ph.D.,
Sebastian Marquez, Ph.D., Tabitha Carreira, MPH, Jessica Powell,
Faizan Badami, M.S., Wei Wu, Ph.D., Amit Etkin, M.D., Ph.D., Adam
J. Savitz, M.D., Ph.D.
Workshop: 4:15-6:15 p.m. ET, Poinciana 3-4
- Presentation Title: Good News/Bad News: Precision
Neuroscience and the Clinical Trials Ecosystem
- Speakers: Mark Opler, Ph.D., M.P.H. (Chair); Adam
Savitz, M.D., Ph.D., Alto Neuroscience; Seth C. Hopkins, Ph.D.,
Sumitomo Pharma America; John Carlos Diaz, GeoSera; John
Sonnenberg, Ph.D., Uptown Research Institute; Barbara Echevarria,
Ph.D., WCG; George Garibaldi, M.D., Garibaldi Consulting GMBH
Wednesday, May 29, 2024 Individual Research Reports: 3:00-4:30
p.m. ET, Salon 2
- Presentation Title: Baseline Cognition is not Associated
with Depression Outcomes with Vortioxetine for Major Depressive
Disorder: Findings from Placebo-controlled Trials
- Poster Authors: Joshua T. Jordan, Ph.D., Li Shen, Ph.D.,
Nicholas J. Cooper, Ph.D., Samantha V. Goncalves, M.S., Madhukar H.
Trivedi, M.D., Alan F. Schatzberg, M.D., Wei Wu, Ph.D., Adam J.
Savitz, M.D., Ph.D., & Amit Etkin, M.D., Ph.D.
Thursday, May 30, 2024 Poster Session II: 12:30-2:15 p.m. ET,
Salon 4
- Presentation Title: A Biomarker-Based Enrichment
Strategy for Neuropsychiatric Drug Development: Examples from Two
Ongoing Phase 2b Studies
- Poster Authors: Michael Avissar, M.D., Ph.D., Joshua T.
Jordan, Ph.D., Nicholas Cooper, Ph.D., Maimon Rose, Ph.D., Chao
Wang, Ph.D., Faizan Badami, M.S., Peter Emmel, Kaitlly Zhu, Jessica
Powell, Fadi Abdel, M.D., Amit Etkin, M.D., Ph.D., Adam J. Savitz,
M.D., Ph.D.
- Presentation Title: Prevalence and Correlates of
Cognitive Impairment in Depression: Findings from the Texas
Resilience Against Depression Study
- Poster Authors: Joshua T. Jordan, Ph.D., Li Shen, Ph.D.,
Cherise Chin-Fatt, Ph.D., Adam J. Savitz, M.D., Ph.D., Amit Etkin,
M.D., Ph.D., & Madhukar H. Trivedi, M.D.
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 its
studies. 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 Alto’s studies 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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version on businesswire.com: https://www.businesswire.com/news/home/20240509520733/en/
Investor Contact Nick Smith
investors@altoneuroscience.com
Media Contact Jordann Merkert
media@altoneuroscience.com
Alto Neuroscience (NYSE:ANRO)
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