Alto Neuroscience Announces Favorable Outcome from Interim Analysis of ALTO-300 Phase 2b Major Depressive Disorder Trial
Alto Neuroscience (NYSE: ANRO) announced favorable interim analysis results for its Phase 2b trial of ALTO-300, an adjunctive treatment for major depressive disorder (MDD). The trial will continue with an increased target of approximately 200 biomarker-positive patients in the final analysis sample, up from the current 87 patients.
The double-blind, placebo-controlled study is enrolling patients characterized by an EEG biomarker signature. ALTO-300, an oral small molecule acting as a melatonin agonist and 5-HT2C antagonist, is being tested as an addition to background antidepressant therapy in patients with inadequate response. The primary outcome measure is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) score.
The company reported an estimated preliminary 2024 year-end cash balance of $168 million, expected to support planned operations into 2028. Topline results are anticipated in mid-2026.
Alto Neuroscience (NYSE: ANRO) ha annunciato risultati favorevoli dell'analisi intermedia per il suo studio di Fase 2b su ALTO-300, un trattamento adiuvante per il disturbo depressivo maggiore (MDD). Lo studio proseguirà con un obiettivo aumentato di circa 200 pazienti positivi ai biomarcatori nel campione finale di analisi, rispetto ai 87 pazienti attuali.
Lo studio, in doppio cieco e controllato con placebo, sta arruolando pazienti caratterizzati da una firma biomarker EEG. ALTO-300, una piccola molecola orale che funge da agonista della melatonina e antagonista del 5-HT2C, è in fase di test come aggiunta alla terapia antidepressiva di base in pazienti con risposta inadeguata. L'indice principale di valutazione è il cambiamento nel punteggio della Montgomery-Åsberg Depression Rating Scale (MADRS).
La società ha riportato un saldo di cassa preliminare stimato per la fine del 2024 di $168 milioni, previsto per supportare le operazioni pianificate fino al 2028. I risultati preliminari sono attesi per metà del 2026.
Alto Neuroscience (NYSE: ANRO) anunció resultados favorables del análisis intermedio para su ensayo de Fase 2b de ALTO-300, un tratamiento adjunto para el trastorno depresivo mayor (MDD). El ensayo continuará con un objetivo aumentado de aproximadamente 200 pacientes positivos a biomarcadores en la muestra de análisis final, en comparación con los 87 pacientes actuales.
El estudio, doble ciego y controlado con placebo, está inscribiendo pacientes caracterizados por una firma de biomarcadores EEG. ALTO-300, una pequeña molécula oral que actúa como agonista de la melatonina y antagonista del 5-HT2C, se está probando como un complemento a la terapia antidepressiva de fondo en pacientes con respuesta inadecuada. La medida de resultado primaria es el cambio en la puntuación de la Escala de Evaluación de la Depresión de Montgomery-Åsberg (MADRS).
La empresa reportó un saldo de caja preliminar estimado para finales de 2024 de $168 millones, que se espera que apoye las operaciones planificadas hasta 2028. Se anticipan resultados preliminares para mediados de 2026.
알토 뉴로사이언스 (NYSE: ANRO)는 ALTO-300의 2b상 시험 중간 분석 결과가 유리하다고 발표했습니다. 이는 주요 우울 장애(MDD)에 대한 보조 치료제입니다. 이 시험은 최종 분석 샘플에서 약 200명의 바이오마커 양성 환자로 목표를 증가시키며, 현재 87명의 환자에서 증가합니다.
이 연구는 EEG 바이오마커 서명이 있는 환자를 등록하는 이중 맹검, 위약 대조 연구입니다. ALTO-300은 멜라토닌 작용제이자 5-HT2C 길항제로 작용하는 경구용 소분자로, 반응이 불충분한 환자에게 기존 항우울제 치료에 추가로 시험되고 있습니다. 주요 결과 측정 기준은 몽고메리-아스베리 우울증 평가 척도(MADRS) 점수의 변화입니다.
회사는 2024년 말 예상되는 초기 현금 잔고가 $168 million으로, 2028년까지 계획된 운영을 지원할 것으로 예상된다고 보고했습니다. 최종 결과는 2026년 중반에 예상됩니다.
Alto Neuroscience (NYSE: ANRO) a annoncé des résultats d'analyse intermédiaire favorables pour son essai de Phase 2b sur ALTO-300, un traitement complémentaire pour le trouble dépressif majeur (MDD). L'essai se poursuivra avec un objectif accru d'environ 200 patients positifs aux biomarqueurs dans l'échantillon d'analyse final, contre 87 patients actuellement.
L'étude en double aveugle et contrôlée par placebo recrute des patients caractérisés par une signature de biomarqueurs EEG. ALTO-300, une petite molécule orale agissant comme agoniste de la mélatonine et antagoniste du 5-HT2C, est testé en complément d'une thérapie antidépresseur de fond chez des patients avec une réponse insuffisante. L'indice principal de résultat est le changement dans le score de l'échelle d'évaluation de la dépression de Montgomery-Åsberg (MADRS).
L'entreprise a rapporté un solde de trésorerie préliminaire estimé à la fin de 2024 de $168 millions, prévu pour soutenir les opérations prévues jusqu'en 2028. Les résultats préliminaires sont attendus pour mi-2026.
Alto Neuroscience (NYSE: ANRO) hat günstige Ergebnisse der Zwischenanalyse seiner Phase-2b-Studie zu ALTO-300 bekannt gegeben, einer ergänzenden Behandlung für die Major Depression (MDD). Die Studie wird mit einem erhöhten Ziel von etwa 200 biomarker-positiven Patienten in der endgültigen Analyseprobe fortgesetzt, verglichen mit derzeit 87 Patienten.
Die doppelblinde, placebo-kontrollierte Studie rekrutiert Patienten, die durch ein EEG-Biomarker-Signatur charakterisiert sind. ALTO-300, ein orales kleines Molekül, das als Melatonin-Agonist und 5-HT2C-Antagonist wirkt, wird als Ergänzung zur Hintergrundtherapie mit Antidepressiva bei Patienten mit unzureichender Reaktion getestet. Die primäre Ergebnisgröße ist die Veränderung des Montgomery-Åsberg Depression Rating Scale (MADRS) Scores.
Das Unternehmen berichtete von einem geschätzten vorläufigen Kassenbestand zum Jahresende 2024 von $168 Millionen, der voraussichtlich die geplanten Operationen bis 2028 unterstützen wird. Die Hauptresultate werden für mitte 2026 erwartet.
- Favorable interim analysis results supporting trial continuation
- Strong cash position of $168M expected to fund operations into 2028
- Clear pathway to completion with defined timeline for topline results
- Extended timeline to topline results (mid-2026)
- Need to increase patient enrollment by approximately 50 biomarker positive patients
Insights
The favorable interim analysis of Alto Neuroscience's ALTO-300 Phase 2b trial reveals several critical insights for investors. The decision to continue the trial with an expanded biomarker-positive population of ~200 patients suggests strong preliminary signals in the initial 87-patient cohort. This biomarker-driven approach, using EEG signatures to select patients, represents a significant advancement in precision psychiatry, potentially increasing the probability of success compared to traditional psychiatric drug development, which typically sees success rates below
The trial's design as an adjunctive therapy is particularly strategic, addressing the substantial market of patients with inadequate response to current antidepressants. ALTO-300's dual mechanism targeting both melatonin and 5-HT2C pathways could provide a distinctive therapeutic advantage in this difficult-to-treat population. The rigorous site and patient eligibility review prior to the interim analysis demonstrates strong clinical trial governance, potentially reducing data noise and increasing the likelihood of detecting true drug effects.
From a financial perspective, the
The precision medicine approach using EEG biomarkers could revolutionize psychiatric treatment by moving away from the current trial-and-error prescription model. If successful, this could lead to higher reimbursement rates and better market penetration, as payers increasingly favor treatments with predictive response markers. The focus on biomarker-positive patient selection could also result in higher effect sizes and more robust clinical data, potentially leading to stronger market positioning.
– Interim analysis resulted in a recommendation to continue the study with a total targeted biomarker population of ~200 patients in the final analysis sample –
– Topline results are expected in mid-2026 –
– The company recently reported an estimated preliminary 2024 year-end cash balance of approximately
“The outcome of this interim analysis marks an important milestone for the ALTO-300 program,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “The interim analysis was an opportunity to leverage valuable insight from the completed ALTO-100 Phase 2b trial, and we are encouraged by these results. We look forward to reporting topline data in mid-2026.”
Prior to the interim analysis, a blinded committee conducted an in-depth site and patient eligibility review that resulted in the prospective exclusion of sites and patients from the analysis population. Following the eligibility review, the biomarker positive population in the interim analysis consisted of 87 patients.
The double-blind, placebo-controlled study (NCT05922878) is enrolling patients characterized by an electroencephalogram (EEG) biomarker signature. The company expects to enroll approximately 200 biomarker positive patients in the final analysis sample. Patients are randomized to receive ALTO-300 or placebo in addition to a background antidepressant, to which they have had inadequate response, over a six-week treatment period. The primary outcome is the change from baseline on the Montgomery-Åsberg Depression Rating Scale, or MADRS, score.
ALTO-300, an oral, small molecule designed to act as a melatonin agonist and 5-HT2C antagonist, is being developed as an adjunctive treatment in
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, schizophrenia, and other mental health conditions. For more information, visit www.altoneuroscience.com or follow Alto on X.
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Source: Alto Neuroscience, Inc.
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