Alto Neuroscience Announces Peer-Reviewed Publication in the Journal of Clinical Psychiatry Demonstrating Baseline Cognitive Performance is Not a Moderator of Response to Standard-of-Care Antidepressants
Alto Neuroscience (NYSE: ANRO) has published a peer-reviewed analysis in The Journal of Clinical Psychiatry, revealing that baseline cognitive performance does not moderate response to standard antidepressants in major depressive disorder (MDD) patients. The study, involving 1,812 participants across four placebo-controlled trials, found that vortioxetine, despite its cognitive benefits, does not show greater efficacy in MDD patients with cognitive impairment.
This underscores the unmet need for effective treatments for MDD patients with cognitive impairment, who comprise up to 50% of the MDD population. Alto Neuroscience is developing ALTO-100, a first-in-class oral small molecule designed to enhance neural plasticity, as a potential treatment for this subgroup. Topline data from the Phase 2b MDD study of ALTO-100 is expected in October 2024.
Alto Neuroscience (NYSE: ANRO) ha pubblicato un'analisi peer-reviewed nel The Journal of Clinical Psychiatry, rivelando che le performance cognitive di base non moderano la risposta agli antidepressivi standard nei pazienti con disturbo depressivo maggiore (DDM). Lo studio, che ha coinvolto 1.812 partecipanti in quattro studi controllati con placebo, ha riscontrato che la vortioxetina, nonostante i suoi benefici cognitivi, non mostra una maggiore efficacia nei pazienti DDM con compromissione cognitiva.
Questo sottolinea il bisogno non soddisfatto di trattamenti efficaci per i pazienti DDM con compromissione cognitiva, che rappresentano fino al 50% della popolazione DDM. Alto Neuroscience sta sviluppando ALTO-100, una piccola molecola orale di prima classe progettata per migliorare la plasticità neurale, come potenziale trattamento per questo sottogruppo. I dati principali dello studio di Fase 2b del DDM di ALTO-100 sono attesi per ottobre 2024.
Alto Neuroscience (NYSE: ANRO) ha publicado un análisis revisado por pares en The Journal of Clinical Psychiatry, revelando que el rendimiento cognitivo inicial no modera la respuesta a los antidepresivos estándar en pacientes con trastorno depresivo mayor (TDM). El estudio, que involucró a 1.812 participantes en cuatro ensayos controlados con placebo, encontró que la vortioxetina, a pesar de sus beneficios cognitivos, no muestra mayor eficacia en pacientes con TDM y deterioro cognitivo.
Esto subraya la necesidad no satisfecha de tratamientos efectivos para pacientes con TDM y deterioro cognitivo, que representan hasta el 50% de la población de TDM. Alto Neuroscience está desarrollando ALTO-100, una molécula pequeña oral de primera clase diseñada para mejorar la plasticidad neural, como tratamiento potencial para este subgrupo. Se esperan los datos principales del estudio de Fase 2b sobre el TDM de ALTO-100 en octubre de 2024.
Alto Neuroscience (NYSE: ANRO)는 The Journal of Clinical Psychiatry에 동료 심사를 거친 분석 결과를 발표하였으며, 이 결과는 기초 인지 능력이 주요 우울장애(MDD) 환자에게 표준 항우울제에 대한 반응을 조절하지 않는다는 것입니다. 1,812명의 참가자가 포함된 네 개의 위약 대조 임상 시험에서 vortioxetine이 인지 치료 효과에도 불구하고 MDD 환자 중 인지 장애가 있는 경우 더 큰 효능을 보이지 않는다는 것을 발견했습니다.
이는 인지 장애가 있는 MDD 환자에게 효과적인 치료법에 대한 충족되지 않은 요구를 보여주며, 이러한 환자는 MDD 인구의 최대 50%를 차지합니다. Alto Neuroscience는 이 하위 그룹을 위한 잠재적 치료로 신경 가소성을 향상하도록 설계된 최초의 경구용 소분자인 ALTO-100을 개발 중입니다. ALTO-100의 MDD에 대한 2b상 임상시험의 주요 데이터는 2024년 10월에 발표될 예정입니다.
Alto Neuroscience (NYSE: ANRO) a publié une analyse examinée par des pairs dans The Journal of Clinical Psychiatry, révélant que la performance cognitive de base ne modère pas la réponse aux antidépresseurs standards chez les patients atteints de trouble dépressif majeur (TDM). L'étude, impliquant 1 812 participants dans quatre essais contrôlés par placebo, a trouvé que la vortioxétine, malgré ses avantages cognitifs, ne montre pas une plus grande efficacité chez les patients TDM avec un trouble cognitif.
Cela souligne le besoin non satisfait de traitements efficaces pour les patients TDM avec un trouble cognitif, qui représentent jusqu'à 50 % de la population TDM. Alto Neuroscience développe ALTO-100, une petite molécule orale de première classe conçue pour améliorer la plasticité neuronale, comme traitement potentiel pour ce sous-groupe. Les résultats principaux de l'étude de Phase 2b sur le TDM d'ALTO-100 sont attendus en octobre 2024.
Alto Neuroscience (NYSE: ANRO) hat eine begutachtete Analyse im The Journal of Clinical Psychiatry veröffentlicht, die zeigt, dass die kognitiven Grundwerte die Reaktion auf Standardantidepressiva bei Patienten mit einer Major Depression (MDD) nicht moderieren. In der Studie, an der 1.812 Teilnehmer in vier placebokontrollierten Studien beteiligt waren, wurde festgestellt, dass Vortioxetin trotz seiner kognitiven Vorteile keine höhere Wirksamkeit bei MDD-Patienten mit kognitiven Beeinträchtigungen zeigt.
Dies verdeutlicht den ungedeckten Bedarf an effektiven Behandlungen für MDD-Patienten mit kognitiven Beeinträchtigungen, die bis zu 50 % der MDD-Population ausmachen. Alto Neuroscience entwickelt ALTO-100, ein oral einzunehmendes kleines Molekül der ersten Klasse, das darauf abzielt, die neuronale Plastizität zu verbessern, als potenzielles Behandlungsmittel für diese Subgruppe. Die Hauptdaten aus der Phase-2b-Studie zu MDD mit ALTO-100 werden für Oktober 2024 erwartet.
- Publication of peer-reviewed analysis in The Journal of Clinical Psychiatry
- Development of ALTO-100 as a potential treatment for MDD patients with cognitive impairment
- Phase 2b MDD study of ALTO-100 with topline data expected in October 2024
- Current standard-of-care antidepressants, including vortioxetine, show no greater efficacy in MDD patients with cognitive impairment
Insights
This publication highlights a critical gap in current major depressive disorder (MDD) treatments. The analysis reveals that baseline cognitive performance does not predict response to standard antidepressants, including vortioxetine, which has been touted for its cognitive benefits. This finding is significant for several reasons:
- It challenges the assumption that cognitive-enhancing antidepressants are more effective for MDD patients with cognitive impairment.
- It underscores the unmet need for targeted therapies for the
50% of MDD patients who experience cognitive deficits. - It supports the potential value of novel approaches like Alto's ALTO-100, which targets neural plasticity rather than monoamine systems.
The study's robust design, involving 1,812 participants across four placebo-controlled trials, lends credibility to these findings. This research could shift focus towards developing more specialized treatments for cognitively impaired MDD patients, potentially opening new avenues for drug development and patient care strategies.
From an investment perspective, this publication has mixed implications for Alto Neuroscience (NYSE: ANRO). On the positive side:
- It highlights a significant market opportunity in MDD patients with cognitive impairment, potentially up to
50% of the MDD population. - It positions Alto's ALTO-100 as a potential first-in-class treatment addressing an unmet need, which could drive substantial value if successful.
- The planned topline data release in October 2024 provides a clear catalyst for potential stock movement.
However, investors should note:
- The Phase 2b study results are still pending and clinical success is not guaranteed.
- The competitive landscape may evolve before ALTO-100 reaches the market.
- The company's financial position and burn rate should be closely monitored, as clinical development is costly.
Overall, while the publication supports Alto's strategic direction, investors should weigh the potential upside against the inherent risks in early-stage biotech investments.
– Despite its reported benefits for aspects of cognition, vortioxetine does not demonstrate greater clinical efficacy in major depressive disorder (MDD) patients with cognitive impairment–
– Findings further underscore the importance of developing ALTO-100 in depression characterized by poor cognition–
Prior studies have shown that patients with depression, who are characterized by poor cognition, are generally more chronic, disabled, resistant to treatment and experience greater functional impairment. The current analysis suggests that, despite its reported benefits for aspects of cognition, the monoamine-based agent vortioxetine does not show greater benefit on depressive symptoms in MDD patients with cognitive impairment.
“These findings highlight the lack of effective treatment options for patients with MDD who experience cognitive impairment, comprising up to
In the publication, which was a reanalysis of individual-level data from 1,812 participants with MDD across four placebo-controlled trials, baseline cognition was measured by the Digit Symbol Substitution Test (DSST), the primary measure used to demonstrate vortioxetine’s procognitive effects in clinical studies. The DSST assesses processing speed and attention, as well as executive function, associative learning and working memory. Baseline DSST did not predict placebo-adjusted treatment effects of vortioxetine on depressive symptoms (pooled Cohen d = −0.02,
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 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 “believe,” “could,” “expects,” “look forward,” “plans,” “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 with regard to the potential benefits, activity, effectiveness and safety of its product candidates and its ability to bring its product candidates to patients, Alto’s expectations for the timing and results of Alto’s Phase 2b study of ALTO-100, and other statements that are not historical fact. 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 clinical trials and clinical development of Alto’s product candidates; availability and timing of results from clinical trials; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that clinical trials may have unsatisfactory outcomes; 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 June 30, 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.
Availability of Information on Alto’s Website
Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240904102112/en/
Nick Smith
investors@altoneuroscience.com
Media Contact:
Mari Purpura
media@altoneuroscience.com
Source: Alto Neuroscience, Inc.
FAQ
What did Alto Neuroscience's study reveal about antidepressant efficacy in MDD patients with cognitive impairment?
When will Alto Neuroscience (ANRO) report topline data from its Phase 2b MDD study of ALTO-100?
What percentage of MDD patients experience cognitive impairment, according to Alto Neuroscience's press release?
How is ALTO-100 different from current antidepressants for MDD patients with cognitive impairment?
