Alto Neuroscience Receives Funding Award from Wellcome Trust to Accelerate Development of ALTO-100 in Bipolar Depression Leveraging Precision Psychiatry Approach
Alto Neuroscience (NYSE: ANRO) has received an $11.7 million funding award from Wellcome Trust to advance ALTO-100, a first-in-class small molecule, in a 200-patient Phase 2b study for bipolar depression. The study will leverage a cognitive biomarker previously identified in MDD and PTSD patients. This marks the first precision psychiatry trial in bipolar depression, an area of high unmet need.
ALTO-100 is believed to enhance neural plasticity and is currently in Phase 2b development for MDD, with results expected in October 2024. The new study for bipolar depression will use the same memory biomarker and design as the ongoing MDD study. The primary endpoint is the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) over a six-week treatment period.
Alto Neuroscience (NYSE: ANRO) ha ricevuto un finanziamento di 11,7 milioni di dollari dal Wellcome Trust per sviluppare ALTO-100, una molecola innovativa, in uno studio di Fase 2b su 200 pazienti per la depressione bipolare. Lo studio sfrutterà un biomarcatore cognitivo precedentemente identificato nei pazienti con DMD e PTSD. Questo segna il primo trial di psichiatria di precisione nella depressione bipolare, un'area con un elevato bisogno insoddisfatto.
Si ritiene che ALTO-100 migliori la plasticità neurale ed è attualmente in sviluppo di Fase 2b per la DMD, con risultati attesi per ottobre 2024. Il nuovo studio per la depressione bipolare utilizzerà lo stesso biomarcatore della memoria e il design dello studio in corso per la DMD. L'endpoint primario è il cambiamento rispetto al basale sulla scala di valutazione della depressione di Montgomery-Åsberg (MADRS) durante un periodo di trattamento di sei settimane.
Alto Neuroscience (NYSE: ANRO) ha recibido un financiamiento de 11.7 millones de dólares del Wellcome Trust para avanzar en ALTO-100, una molécula innovadora, en un estudio de Fase 2b con 200 pacientes para la depresión bipolar. El estudio aprovechará un biomarcador cognitivo previamente identificado en pacientes con DMD y PTSD. Esto marca el primer ensayo de psiquiatría de precisión en la depresión bipolar, un área de alta necesidad no satisfecha.
Se cree que ALTO-100 mejora la plasticidad neuronal y actualmente está en desarrollo de Fase 2b para la DMD, con resultados esperados para octubre de 2024. El nuevo estudio para la depresión bipolar utilizará el mismo biomarcador de memoria y diseño que el estudio en curso para la DMD. El objetivo primario es el cambio desde el inicio en la Escala de Evaluación de Depresión de Montgomery-Åsberg (MADRS) durante un período de tratamiento de seis semanas.
알토 뉴로사이언스(뉴욕증권거래소: ANRO)는 1170만 달러의 자금 지원을 웰컴 트러스트로부터 받아 ALTO-100, 최초의 클래스 소분자에 대한 200명 환자를 대상으로 한 제2b상 연구를 진행하게 됩니다. 이 연구는 MDD(주요 우울 장애) 및 PTSD(외상 후 스트레스 장애) 환자에서 이전에 확인된 인지 바이오마커를 활용합니다. 이는 양극성 우울증에 대한 첫 번째 정밀 정신의학 시험을 의미합니다, 이는 충족되지 않은 높은 수요가 있는 분야입니다.
ALTO-100은 신경가소성을 증진시키는 것으로 알려져 있으며 현재 MDD에 대해 제2b상 개발 중이며, 2024년 10월에 결과가 나올 예정입니다. 양극성 우울증에 대한 새로운 연구는 진행 중인 MDD 연구와 동일한 기억 바이오마커와 디자인을 사용할 것입니다. 주요 목표는 6주 치료 기간 동안 Montgomery-Åsberg 우울증 평가 척도(MADRS)의 기준선 변화입니다.
Alto Neuroscience (NYSE : ANRO) a reçu une subvention de financement de 11,7 millions de dollars de la Wellcome Trust pour faire avancer ALTO-100, une petite molécule de première classe, dans une étude de Phase 2b impliquant 200 patients atteints de dépression bipolaire. L'étude s'appuiera sur un biomarqueur cognitif précédemment identifié chez des patients atteints de DMD et de PTSD. Cela marque le premier essai de psychiatrie de précision dans la dépression bipolaire, un domaine de besoins non satisfaits importants.
ALTO-100 est censé améliorer la plasticité neurale et est actuellement en développement de Phase 2b pour la DMD, avec des résultats attendus en octobre 2024. La nouvelle étude pour la dépression bipolaire utilisera le même biomarqueur de mémoire et le même design que l'étude DMD en cours. L'objectif principal est le changement par rapport à la ligne de base sur l'échelle d'évaluation de la dépression de Montgomery-Åsberg (MADRS) pendant une période de traitement de six semaines.
Alto Neuroscience (NYSE: ANRO) hat eine Fördermittel in Höhe von 11,7 Millionen US-Dollar vom Wellcome Trust erhalten, um ALTO-100, ein erstes Mittel seiner Klasse, in einer Phase-2b-Studie mit 200 Patienten zur bipolaren Depression voranzutreiben. Die Studie wird einen kognitiven Biomarker nutzen, der zuvor bei Patienten mit MDD und PTSD identifiziert wurde. Dies stellt die erste Präzisionspsychiatrie-Studie bei bipolaren Depressionen dar, einem Bereich mit hohem ungedecktem Bedarf.
Es wird angenommen, dass ALTO-100 die neuronale Plastizität verbessert und sich derzeit in der Phase 2b-Entwicklung für MDD befindet, mit Ergebnissen, die im Oktober 2024 erwartet werden. Die neue Studie zur bipolaren Depression wird denselben Gedächtnisbiomarker und das Design wie die laufende MDD-Studie verwenden. Der primäre Endpunkt ist die Veränderung vom Ausgangswert auf der Montgomery-Åsberg Depression Rating Scale (MADRS) über einen Zeitraum von sechs Wochen Behandlung.
- Received $11.7 million funding from Wellcome Trust for Phase 2b study
- First precision psychiatry trial in bipolar depression, addressing high unmet need
- Leveraging cognitive biomarker previously identified in MDD and PTSD patients
- ALTO-100 showed positive results in Phase 2a study for MDD and PTSD
- Ongoing Phase 2b study for MDD with results expected in October 2024
- None.
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– Alto will leverage the same cognitive biomarker being used in the ongoing Phase 2b MDD, which was previously identified and replicated in MDD and PTSD patients –
– This study represents the first precision psychiatry trial in bipolar depression, an indication identified by Wellcome Trust as an area of high unmet need in mental health with under-representation across drug development efforts –
“Bipolar depression is among the most challenging psychiatric conditions, yet the only available treatments are antipsychotics, which carry limited efficacy and substantial side effects,” said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. “Bipolar depression is associated with memory, cognitive, and neuroplasticity abnormalities at similar or greater rates than seen in major depression. Given the pro-neuroplasticity mechanism of ALTO-100, we have an opportunity to address an important subset of patients displaying a similar neurobiological profile. We are grateful to Wellcome for their commitment to addressing this devastating condition and eagerness to accelerate our late-stage clinical program as we work to develop the first precision treatment for bipolar disorder.”
Dr. Lynsey Bilsland, Head of Mental Health Translation at Wellcome, added, “We are committed to funding research and innovation to advance early intervention in mental health, helping create a world where people do not feel held back from the lives they wish to lead. We’re encouraged by Alto’s precision psychiatry drug candidate, which has the potential to have a significant impact on patients affected by bipolar depression and other mental health conditions. To make meaningful and effective progress, we must support these opportunities that promote targeted treatment approaches for patients, particularly in an industry that has relied on trial-and-error for too long.”
ALTO-100, a first-in-class, oral small molecule believed to work through enhancing neural plasticity, is currently in Phase 2b development for the treatment of major depressive disorder (MDD), with topline results expected in October 2024. Previously, Alto reported positive results from a Phase 2a study of ALTO-100 in MDD and post-traumatic stress disorder (PTSD), in which favorable safety and tolerability were established, and patients with a memory-based cognitive biomarker signature exhibited greater response to the drug candidate.
The Company is leveraging the same memory biomarker and study design being employed in the ongoing Phase 2b study of ALTO-100 in MDD. The randomized, double-blind, placebo-controlled study is expected to enroll approximately 200 adults with bipolar depression. Patients will be evaluated over a six-week treatment period. The primary endpoint is the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS), consistent with the endpoint in the ongoing Phase 2b MDD study, and the commonly used endpoint in registrational studies in bipolar depression.
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.
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
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) and bipolar depression, disease states characterized by cognitive impairment with no currently available treatments targeting these symptoms. In Phase 2a clinical trials, 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.
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 Alto’s Phase 2b study of Alto-100 in patients with bipolar depression, 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 Alto’s Phase 2b study of Alto-100 in patients with bipolar depression; the risk that Alto may not achieve the targeted enrollment in the study or that enrollment may take longer than expected; the availability and timing of results from the 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, 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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Source: Alto Neuroscience, Inc.
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