Athira Pharma to Present Results from Phase 2/3 LIFT-AD Clinical Trial of Fosgonimeton at the Clinical Trials on Alzheimer’s Disease (CTAD) 2024 Meeting
Athira Pharma (NASDAQ: ATHA) announced that results from the Phase 2/3 LIFT-AD clinical trial of fosgonimeton for Alzheimer's disease will be presented at the 17th Annual Clinical Trials on Alzheimer's Disease (CTAD) meeting in Madrid, Spain. The presentation, titled "Fosgonimeton for the Treatment of Alzheimer's Disease; Efficacy and Safety Results from the LIFT-AD Trial," will be given by Dr. Anton P. Porsteinsson on October 29, 2024.
While the trial did not achieve statistical significance for its primary and key secondary endpoints, cognition and function directionally favored fosgonimeton treatment. In pre-specified subgroups with more rapid disease progression, improvements or stabilization were observed. Biomarker data showed directional changes supporting fosgonimeton's neuroprotective mechanism.
Athira is now focusing on ATH-1105, a novel oral small molecule for neurodegenerative diseases, currently in a Phase 1 trial with healthy volunteers. The company aims to begin dosing ALS patients in 2025.
Athira Pharma (NASDAQ: ATHA) ha annunciato che i risultati della sperimentazione clinica di fase 2/3 LIFT-AD del fosgonimeton per il morbo di Alzheimer saranno presentati alla 17ª Conferenza Annuale sulle Sperimentazioni Cliniche sul Morbo di Alzheimer (CTAD) che si svolgerà a Madrid, Spagna. La presentazione, intitolata "Fosgonimeton per il Trattamento del Morbo di Alzheimer; Risultati di Efficacia e Sicurezza dalla Sperimentazione LIFT-AD," sarà effettuata dal Dr. Anton P. Porsteinsson il 29 ottobre 2024.
Sebbene lo studio non abbia raggiunto significatività statistica per i suoi obiettivi primari e secondari chiave, la cognizione e la funzione hanno favorevolmente indirizzato il trattamento con fosgonimeton. In sottogruppi predefiniti con una progressione della malattia più rapida, sono stati osservati miglioramenti o stabilizzazione. I dati sui biomarcatori hanno mostrato cambiamenti direzionali a sostegno del meccanismo neuroprotettivo del fosgonimeton.
Athira si sta ora concentrando su ATH-1105, una nuova molecola orale per malattie neurodegenerative, attualmente in fase 1 con volontari sani. L'azienda prevede di iniziare a dosare i pazienti affetti da SLA nel 2025.
Athira Pharma (NASDAQ: ATHA) anunció que los resultados del ensayo clínico de fase 2/3 LIFT-AD del fosgonimeton para la enfermedad de Alzheimer se presentarán en la 17ª Reunión Anual de Ensayos Clínicos sobre la Enfermedad de Alzheimer (CTAD) que se llevará a cabo en Madrid, España. La presentación, titulada "Fosgonimeton para el Tratamiento de la Enfermedad de Alzheimer; Resultados de Eficacia y Seguridad del Ensayo LIFT-AD," será realizada por el Dr. Anton P. Porsteinsson el 29 de octubre de 2024.
Si bien el ensayo no logró alcanzar significancia estadística para sus objetivos primarios y secundarios clave, la cognición y la función favorecieron direccionalmente el tratamiento con fosgonimeton. En subgrupos predefinidos con una progresión de enfermedad más rápida, se observaron mejoras o estabilización. Los datos de biomarcadores mostraron cambios direccionales que apoyan el mecanismo neuroprotector del fosgonimeton.
Athira ahora se está enfocando en ATH-1105, una nueva molécula pequeña oral para enfermedades neurodegenerativas, actualmente en un ensayo de fase 1 con voluntarios sanos. La empresa espera comenzar a tratar a pacientes con ELA en 2025.
Athira Pharma (NASDAQ: ATHA)는 알츠하이머병에 대한 fosgonimeton의 2/3상 LIFT-AD 임상 시험 결과가 스페인 마드리드에서 열리는 제17회 알츠하이머병 임상 시험 회의(CTAD)에서 발표될 것이라고 발표했습니다. 발표 제목은 "알츠하이머병 치료를 위한 Fosgonimeton; LIFT-AD 시험의 효능 및 안전성 결과"이며, Dr. Anton P. Porsteinsson이 2024년 10월 29일에 발표할 예정입니다.
시험은 주요 및 핵심 2차 목표에서 통계적 유의성을 달성하지 못했지만, 인지 기능과 기능은 fosgonimeton 치료에 방향성을 두고 긍정적인 결과를 보였습니다. 질병 진행이 더 빠른 사전 지정된 하위 그룹에서는 개선 또는 안정화가 관찰되었습니다. 바이오마커 데이터는 fosgonimeton의 신경 보호 메커니즘을 지원하는 방향성 변화를 보여주었습니다.
Athira는 현재 건강한 자원봉사자를 대상으로 하는 1상 시험 중인 신약인 ATH-1105에 집중하고 있습니다. 이 회사는 2025년부터 ALS 환자에 대한 투여를 시작할 계획입니다.
Athira Pharma (NASDAQ: ATHA) a annoncé que les résultats de l'essai clinique de phase 2/3 LIFT-AD du fosgonimeton pour la maladie d'Alzheimer seront présentés lors de la 17ème Réunion Annuelle des Essais Cliniques sur la Maladie d'Alzheimer (CTAD) à Madrid, Espagne. La présentation, intitulée "Fosgonimeton pour le Traitement de la Maladie d'Alzheimer; Résultats d'Efficacité et de Sécurité de l'Essai LIFT-AD," sera effectuée par le Dr. Anton P. Porsteinsson le 29 octobre 2024.
Bien que l'essai n'ait pas atteint la signification statistique de ses objectifs principaux et secondaires clés, la cognition et la fonction ont tendanciellement favorisé le traitement par fosgonimeton. Dans des sous-groupes prédéfinis avec une progression rapide de la maladie, des améliorations ou une stabilisation ont été observées. Les données sur les biomarqueurs ont montré des changements directionnels soutenant le mécanisme neuroprotecteur du fosgonimeton.
Athira se concentre maintenant sur ATH-1105, une nouvelle petite molécule orale pour les maladies neurodégénératives, actuellement dans un essai de phase 1 avec des volontaires sains. L'entreprise prévoit de commencer à administrer aux patients atteints de SLA en 2025.
Athira Pharma (NASDAQ: ATHA) hat angekündigt, dass die Ergebnisse der Phase 2/3 LIFT-AD-Studie mit fosgonimeton zur Behandlung von Alzheimer auf dem 17. Jahreskongress über Klinische Studien zur Alzheimer-Krankheit (CTAD) in Madrid, Spanien, präsentiert werden. Die Präsentation mit dem Titel "Fosgonimeton zur Behandlung von Alzheimer; Wirksamkeits- und Sicherheitsdaten aus der LIFT-AD-Studie" wird am 29. Oktober 2024 von Dr. Anton P. Porsteinsson gehalten.
Obwohl die Studie für ihre primären und wesentlichen sekundären Endpunkte keine statistische Signifikanz erzielte, zeigten sich bei Kognition und Funktion tendenziell positive Ergebnisse für die Behandlung mit fosgonimeton. In vordefinierten Untergruppen mit schnelleren Krankheitsverläufen wurden Verbesserungen oder Stabilisierung beobachtet. Biomarker-Daten zeigten Richtungsänderungen, die den neuroprotektiven Mechanismus von fosgonimeton unterstützen.
Athira konzentriert sich nun auf ATH-1105, ein neuartiges orales kleines Molekül für neurodegenerative Erkrankungen, das sich derzeit in einer Phase-1-Studie mit gesunden Probanden befindet. Das Unternehmen plant, 2025 mit der Verabreichung an ALS-Patienten zu beginnen.
- Presentation of LIFT-AD trial results at a major Alzheimer's disease conference
- Directional improvements in cognition and function for fosgonimeton in specific subgroups
- Biomarker data supporting fosgonimeton's neuroprotective mechanism
- Advancement of ATH-1105 to Phase 1 clinical trial
- Planned expansion of ATH-1105 to ALS patients in 2025
- LIFT-AD trial failed to achieve statistical significance for primary and key secondary endpoints
- Shift in focus from fosgonimeton to ATH-1105 suggests potential abandonment of the former drug candidate
Insights
The presentation of LIFT-AD trial results for fosgonimeton at CTAD 2024 is noteworthy, but the lack of statistical significance in primary and key secondary endpoints is concerning. However, the directional improvements in cognition and function, especially in subgroups with rapid disease progression, warrant attention.
The biomarker data showing favorable changes in protein pathology, inflammation and neurodegeneration markers aligns with fosgonimeton's proposed mechanism. This supports further investigation into HGF modulation for neurodegenerative diseases.
Athira's pivot to ATH-1105, a next-generation HGF modulator, for ALS and AD is strategic. The ongoing Phase 1 trial and plans to dose ALS patients in 2025 indicate a shift in pipeline focus. This approach could potentially address the limitations seen with fosgonimeton while leveraging insights gained from the LIFT-AD trial.
BOTHELL, Wash., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that results from the Phase 2/3 LIFT-AD clinical trial of fosgonimeton to treat Alzheimer’s disease (AD) will be presented at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) taking place October 29 - November 1, 2024, in Madrid, Spain.
Presentation Details:
Title: Fosgonimeton for the Treatment of Alzheimer’s Disease; Efficacy and Safety Results from the LIFT-AD Trial
Session: Oral Communications: OC2
Date/Time: Tuesday, October 29 at 5:10 p.m., CET
Presenter: Anton P. Porsteinsson, M.D., Director of the University of Rochester Alzheimer’s Disease Care, Research, and Education Program (AD-CARE) and a LIFT-AD investigator
As previously reported, topline results from the LIFT-AD trial did not achieve statistical significance for the primary endpoint of the Global Statistical Test (GST) nor its key secondary endpoints compared with placebo at 26 weeks. However, both components of GST, cognition (ADAS-Cog11) and function (ADCS-ADL23), directionally favored fosgonimeton treatment, and in pre-specified subgroups characterized by more rapid disease progression (moderate AD and APOE4 carriers), cognition and function improved or stabilized in the fosgonimeton treated group. In addition, data across biomarkers of protein pathology (Aβ42/40, p-Tau181, and p-Tau217), inflammation (GFAP) and neurodegeneration (NfL) showed directional changes in favor of fosgonimeton treatment that are consistent with the broad neuroprotective mechanism of HGF modulation.
“We believe the totality of the data supports the potential of HGF modulation for the treatment of neurodegenerative diseases,” said Javier San Martin, M.D., Chief Medical Officer of Athira.
Athira is focused on advancing the clinical development program for ATH-1105, a novel, oral, next-generation small molecule positive modulator of the neurotrophic hepatocyte growth factor (HGF) system, as a potential treatment for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease (AD). Athira is conducting a first-in-human Phase 1 (NCT 06432647) double-blind, placebo-controlled trial that is enrolling up to 80 healthy volunteers. The study is evaluating the safety and tolerability of ATH-1105 and includes measurements of pharmacokinetic outcomes. Athira completed the first cohort of healthy volunteers in June 2024 and expects to complete the full study by year-end 2024, with a goal to begin dosing ALS patients in 2025.
About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to alter the course of neurological diseases by advancing its pipeline of drug candidates that modulate the neurotrophic HGF system. For more information, visit www.athira.com. You can also follow Athira on Facebook, LinkedIn, X (formerly known as Twitter) and Instagram.
Forward-Looking Statements
This communication contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: Athira’s drug candidates as potential treatments for Alzheimer’s disease, amyotrophic lateral sclerosis, and other neurodegenerative diseases; future development plans; the anticipated timing of its ongoing clinical trials and planned clinical trials; the potential learnings from preclinical studies and other nonclinical data, the LIFT-AD trial, and the ongoing Phase 1 trial of ATH-1105 and their ability to inform and improve future clinical development plans; expectations regarding the potential efficacy and commercial potential of Athira’s drug candidates and regarding the safety and tolerability of ATH-1105; Athira’s ability to advance its drug candidates into later stages of development; Athira’s planned focus on the development of ATH-1105 for the treatment of amyotrophic lateral sclerosis; the ability to advance product candidates into later stages of development; and other information that is not historical information. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “on track,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” “continue,” “suggest,” “potential,” “target” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the data from preclinical and clinical trials may not support the safety, efficacy and tolerability of Athira’s drug candidates; development of drug candidates may cease or be delayed; regulatory authorities could object to protocols, amendments and other submissions; future potential regulatory milestones for drug candidates, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; Athira may not be able to recruit sufficient patients for its clinical trials; the outcome of legal proceedings that have been or may in the future be instituted against Athira, its directors and officers; possible negative interactions of Athira's drug candidates with other treatments; Athira’s assumptions regarding its financial condition and the sufficiency of its cash, cash equivalents and investments to fund its planned operations may be incorrect; adverse conditions in the general domestic and global economic markets; the impact of competition; the impact of new or changing laws and regulations; Athira may be unable to enter into new partnerships, financings or collaborations; as well as the other risks detailed in Athira’s filings with the Securities and Exchange Commission from time to time. These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements. Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.
Investor & Media Contact:
Julie Rathbun
Athira Pharma
Julie.rathbun@athira.com
206-769-9219
Corporate Development Contact:
Maya Kneip
Program Manager, Portfolio & Program Management
Maya.kneip@athira.com
(206) 412-9078
FAQ
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