Alto Neuroscience Announces Enrollment Completion in Phase 2b Study of ALTO-100 in Major Depressive Disorder
Alto Neuroscience (NYSE: ANRO) has completed enrollment in its Phase 2b study of ALTO-100 for major depressive disorder (MDD). The study includes 300 adult patients with and without a specific cognitive biomarker. Topline results are expected in October 2024. The randomized, double-blind, placebo-controlled study aims to determine ALTO-100's efficacy in MDD patients defined by an objective cognitive biomarker. The primary endpoint is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) over a 6-week treatment period. Alto plans to host an investor day on September 9, 2024, focusing on ALTO-100 and providing information on study participants, mechanistic rationale, and the predictive cognitive test used for patient selection.
- Completed enrollment of 300 patients in Phase 2b study for ALTO-100 in MDD
- On track to report topline data in October 2024
- Study design includes patients with and without the cognitive biomarker, potentially broadening the drug's applicability
- Successful execution demonstrates potential for broad implementation of the neurocognitive test in clinical practice
- None.
Insights
Alto Neuroscience's announcement regarding the completion of enrollment for their Phase 2b study of ALTO-100 in major depressive disorder (MDD) patients lays a promising groundwork for future developments in precision medicine. The study's design, which includes patients both with and without a specific cognitive biomarker, is particularly noteworthy.
The primary endpoint in this study is the change in the Montgomery-Åsberg Depression Rating Scale (MADRS), a gold-standard measure in depressive disorders. The inclusion of a cognitive biomarker is a progressive approach that could potentially enhance the specificity and effectiveness of treatments. Precision psychiatry is receiving increasing attention and if ALTO-100 demonstrates efficacy based on the cognitive biomarker, this could signify a shift in how treatments for MDD are personalized and administered.
However, it is important to remain cautious as these outcomes are expected only in October 2024. As a retail investor, understanding this timeline is critical, as the stock may not see significant movement until the release of these results. The delay between now and the topline data readout means investors must be patient and vigilant regarding any emerging data or related developments in the interim.
From a financial perspective, the completion of enrollment in the Phase 2b study is an important milestone for Alto Neuroscience. This milestone demonstrates operational efficiency and could instill confidence among investors regarding the company's ability to execute complex clinical trials. The potential move to Phase 3, contingent on positive results in October 2024, would mark a significant value inflection point for Alto.
Alto's focus on high-prevalence conditions such as MDD aligns well with its potential market opportunity. However, investors should note that clinical trials can be unpredictable and the risk of not achieving favorable outcomes remains. The announcement of an investor day on September 9, 2024, also provides a marker for potential short-term stock movement as more detailed information about the study becomes available. This event could serve as a catalyst, dependent on the nuances of the data shared and any forward-looking statements made by the management.
Retail investors should keep an eye on secondary indicators such as patient adherence rates, trial dropout rates and any emerging safety concerns, as these could impact the trial's outcomes and the company's valuation.
– 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 –
“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
“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.
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Investor Contact
Nick Smith
investors@altoneuroscience.com
Media Contact
Jordann Merkert
media@altoneuroscience.com
Source: Alto Neuroscience, Inc.
FAQ
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