Athira Pharma Presents Preclinical Data Demonstrating New Insights into the Mechanism by Which Fosgonimeton Protects Neurons from Alzheimer’s Disease-Related Pathology at the Alzheimer’s Association International Conference (AAIC) 2024
Athira Pharma (NASDAQ: ATHA) presented new preclinical data on fosgonimeton at the Alzheimer's Association International Conference (AAIC) 2024. The data demonstrated fosgonimeton's ability to mitigate amyloid-β-induced toxicity, lower pTau levels, and reduce disruption of protein clearance mechanisms in Alzheimer's disease models. Notably, fosgonimeton showed neuroprotective effects against amyloid-β toxicity in primary neurons, both alone and in combination with lecanemab. The research suggests that fosgonimeton may attenuate pTau pathology by improving autophagy, a cellular process impaired in Alzheimer's. These findings support Athira's approach of targeting the neurotrophic HGF system as a potential Alzheimer's treatment and suggest potential benefits of combining fosgonimeton with amyloid-β-targeting monoclonal antibodies.
Athira Pharma (NASDAQ: ATHA) ha presentato nuovi dati preclinici su fosgonimeton durante la Conferenza Internazionale 2024 dell'Associazione Alzheimer (AAIC). I dati hanno dimostrato la capacità di fosgonimeton di mitigare la tossicità indotta da amiloide-β, ridurre i livelli di pTau e diminuire la destabilizzazione dei meccanismi di clearance proteica nei modelli di malattia di Alzheimer. In particolare, fosgonimeton ha mostrato effetti neuroprotettivi contro la tossicità da amiloide-β in neuroni primari, sia da solo che in combinazione con lecanemab. La ricerca suggerisce che fosgonimeton potrebbe attenuare la patologia da pTau migliorando l'autofagia, un processo cellulare compromesso nell'Alzheimer. Questi risultati supportano l'approccio di Athira di mirare al sistema neurotrofico HGF come potenziale trattamento per l'Alzheimer e suggeriscono vantaggi potenziali della combinazione di fosgonimeton con anticorpi monoclonali diretti contro l'amiloide-β.
Athira Pharma (NASDAQ: ATHA) presentó nuevos datos preclínicos sobre fosgonimeton en la Conferencia Internacional de la Asociación de Alzheimer (AAIC) 2024. Los datos demostraron la capacidad de fosgonimeton para mitigar la toxicidad inducida por amiloide-β, reducir los niveles de pTau y disminuir la alteración de los mecanismos de eliminación de proteínas en modelos de enfermedad de Alzheimer. Cabe destacar que fosgonimeton mostró efectos neuroprotectores contra la toxicidad de amiloide-β en neuronas primarias, tanto solo como en combinación con lecanemab. La investigación sugiere que fosgonimeton podría atenuar la patología de pTau mejorando la autofagia, un proceso celular afectado en Alzheimer. Estos hallazgos respaldan el enfoque de Athira de dirigir el sistema neurotrófico HGF como un tratamiento potencial para el Alzheimer y sugieren beneficios potenciales de combinar fosgonimeton con anticuerpos monoclonales dirigidos contra amiloide-β.
아티라 파마(Athira Pharma, NASDAQ: ATHA)는 2024년 알츠하이머 협회 국제 회의(AAIC)에서 포스고니메톤(fosgonimeton)에 대한 새로운 전임상 데이터를 발표했습니다. 데이터는 포스고니메톤이 아밀로이드-β 유도 독성 완화, pTau 수치 감소, 알츠하이머 모델에서 단백질 제거 메커니즘의 혼란을 줄이는 능력을 보여주었습니다. 특히 포스고니메톤은 주로 뉴런에서 아밀로이드-β 독성에 대한 신경 보호 효과를 보였으며, 단독으로 사용하거나 레카네맙(lecanemab)과 함께 사용할 때 모두 효과적이었습니다. 연구는 포스고니메톤이 pTau 병리 완화에 기여할 수 있을 것으로 시사하며, 이는 알츠하이머에서 손상된 세포 과정인 자가포식을 개선함으로써 이루어질 수 있습니다. 이러한 결과는 알츠하이머에 대한 잠재적인 치료법으로 신경영양 HGF 시스템을 목표로 하는 아티라의 접근 방식을 지원하며, 아밀로이드-β를 타겟으로 하는 단클론 항체와 포스고니메톤을 결합할 가능성과 이점에 대한 시사를 제공하고 있습니다.
Athira Pharma (NASDAQ: ATHA) a présenté de nouvelles données précliniques sur le fosgonimeton lors de la Conférence Internationale de l’Association Alzheimer (AAIC) 2024. Les données ont démontré la capacité du fosgonimeton à atténuer la toxicité induite par l'amiloïde-β, à réduire les niveaux de pTau et à diminuer la perturbation des mécanismes d'élimination des protéines dans des modèles de la maladie d'Alzheimer. Notamment, le fosgonimeton a montré des effets neuroprotecteurs contre la toxicité de l'amiloïde-β dans des neurones primaires, tant seul qu'en combinaison avec lecanemab. La recherche suggère que le fosgonimeton pourrait atténuer la pathologie pTau en améliorant l'autophagie, un processus cellulaire compromis dans l'Alzheimer. Ces résultats soutiennent l'approche d'Athira visant à cibler le système neurotrophique HGF comme traitement potentiel contre la maladie d'Alzheimer et suggèrent des bénéfices potentiels de la combinaison du fosgonimeton avec des anticorps monoclonaux ciblant l'amiloïde-β.
Athira Pharma (NASDAQ: ATHA) hat auf der Internationalen Alzheimer-Konferenz 2024 (AAIC) neue präkli-nische Daten zu fosgonimeton präsentiert. Die Daten zeigten die Fähigkeit von fosgonimeton, die durch Amyloid-β induzierte Toxizität zu mindern, die pTau-Spiegel zu senken und die Störung der Mechanismen zur Proteinverwertung in Alzheimer-Modellen zu reduzieren. Besonders bemerkenswert ist, dass fosgonimeton neuroprotektive Effekte gegen die Toxizität von Amyloid-β in primären Neuronen zeigte, sowohl allein als auch in Kombination mit lecanemab. Die Forschung legt nahe, dass fosgonimeton pTau-Pathologie abschwächen könnte, indem es die Autophagie verbessert, einen zellulären Prozess, der bei Alzheimer beeinträchtigt ist. Diese Ergebnisse unterstützen den Ansatz von Athira, das neurotrophe HGF-System als potenzielle Alzheimer-Therapie anzusprechen, und deuten auf mögliche Vorteile einer Kombination von fosgonimeton mit Monoklonalen Antikörpern hin, die auf Amyloid-β abzielen.
- Fosgonimeton demonstrated neuroprotective effects against amyloid-β toxicity in primary neurons
- The combination of fosgonimeton and lecanemab showed potential for enhanced neuroprotection
- Preclinical data supports the investigation of fosgonimeton as a potential Alzheimer's treatment
- Fosgonimeton showed ability to mitigate amyloid-β-induced disruption of autophagy
- None.
As a Medical Research Analyst, I find the preclinical data presented by Athira Pharma on fosgonimeton at AAIC 2024 intriguing, albeit still in early stages. The research highlights two key aspects of fosgonimeton's potential in Alzheimer's disease (AD) treatment:
- Mitigation of amyloid-β-induced autophagy disruption
- Neuroprotective effects against amyloid-β toxicity, both alone and in combination with lecanemab
The first finding is particularly noteworthy. Autophagy, the cellular "cleaning" process, is important for removing toxic proteins like pTau. If fosgonimeton can indeed improve autophagy in AD-affected neurons, it could potentially slow disease progression by reducing pTau accumulation.
The second finding, showing fosgonimeton's neuroprotective effects in combination with lecanemab, is also promising. This suggests a potential for combination therapy, which could be more effective than monotherapies in addressing the complex pathology of AD.
However, it's important to remember that these are preclinical results. The translation from in vitro studies to clinical efficacy is notoriously challenging in AD research. Many promising preclinical candidates have failed to show significant benefits in human trials. Therefore, while these results are encouraging, they should be interpreted cautiously until confirmed in clinical studies.
Investors should closely monitor Athira's ongoing clinical trials, particularly the Phase 2/3 LIFT-AD study, to see if these preclinical benefits translate into measurable cognitive improvements in AD patients. The results of these trials will be far more indicative of fosgonimeton's potential as a viable AD treatment.
From a financial perspective, Athira Pharma's presentation at AAIC 2024 offers some potentially positive signals for investors, but it's important to maintain a balanced view. Here's why:
- Positive preclinical data can increase investor confidence and potentially boost stock value in the short term.
- The suggestion of fosgonimeton's efficacy in combination with lecanemab could open doors for partnership opportunities with larger pharmaceutical companies.
- However, the Alzheimer's drug market is highly competitive and fraught with failures, even at late stages of development.
Athira's market position (
Investors should consider that while preclinical data is promising, it's several steps removed from FDA approval and commercialization. The real value inflection points for Athira will come with the results of their ongoing clinical trials, particularly the Phase 2/3 LIFT-AD study.
It's also worth noting that Athira has faced challenges in the past, including a
In conclusion, while this preclinical data is encouraging, it doesn't significantly alter Athira's risk profile or near-term financial prospects. Investors should continue to focus on upcoming clinical trial results as the key determinants of Athira's future value.
Fosgonimeton mitigated amyloid-β-induced toxicity, lowered pTau levels and reduced disruption of protein clearance mechanisms that may contribute to pTau pathology
Fosgonimeton treatment, alone and in combination with lecanemab, protected cultures of primary neurons from the toxic effects of amyloid-β
BOTHELL, Wash., July 31, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, presented new preclinical data further highlighting the therapeutic potential of fosgonimeton at the Alzheimer’s Association International Conference (AAIC) 2024, being held in Philadelphia from July 28-Aug. 1, 2024.
“We are pleased to be presenting new preclinical data at AAIC 2024 that further demonstrate the broad neuroprotective activity of fosgonimeton and its effects on Alzheimer’s disease-related protein pathology,” said Kevin Church, Ph.D., Chief Scientific Officer of Athira. “Previous preclinical studies have shown that fosgonimeton protects neurons through several mechanisms, including reducing inflammation, improving mitochondrial function, activating prosurvival signaling pathways, and reducing levels of pTau. Here, we described potential mechanisms as to how fosgonimeton treatment may impact levels of key pathological proteins in Alzheimer’s disease models. We also demonstrated that the neuroprotective ability of fosgonimeton against amyloid-β-induced toxicity in primary neurons is maintained in the presence of lecanemab, and, in some conditions, the combination of fosgonimeton and lecanemab led to numerically higher levels of neuroprotection”
“These preclinical data are compelling as they showed fosgonimeton attenuated amyloid-β-induced autophagic impairments in primary cortical neurons, which may have important implications regarding the attenuation of pTau pathology in Alzheimer’s disease,” stated Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “Preclinical data such as these support our novel approach to targeting the neurotrophic HGF system as a potential treatment for Alzheimer’s disease and add more insights into the pleotropic effect of fosgonimeton in Alzheimer’s disease pathology. We look forward to potentially demonstrating how enhancing this system may translate into clinical benefit.”
AAIC 2024 Presentation Details
Title: Fosgonimeton attenuates amyloid-β-induced autophagic impairments in primary cortical neurons
Poster: #49
Date/Time: Wednesday, July 31, 8:00 a.m. ET – 4:15 p.m. ET
Presenter: Sherif Reda, Ph.D., Associate Director, Discovery Biology, Athira Pharma
Highlights of this presentation show that:
- Fosgonimeton can mitigate amyloid-β-induced disruption of autophagy, an essential cellular process that plays a key role in the removal of pathological proteins, such as pTau, and is known to be impaired in Alzheimer’s disease.
- Improvement in autophagy may partly explain the reduction in pTau observed in these models and suggest that fosgonimeton may have beneficial impacts on key indicators of protein pathology, and the associated neurodegeneration in Alzheimer’s disease.
Title: Neuroprotective effects of fosgonimeton and amyloid-β-targeting monoclonal antibodies against amyloid-β toxicity in primary neuron culture
Poster: #50
Date/Time: Wednesday, July 31, 8:00 a.m. ET – 4:15 p.m. ET
Presenter: Robert W. Taylor, PhD, Director, Discovery Biology, Athira Pharma
Highlights of this presentation show that:
- Fosgonimeton is neuroprotective against amyloid-beta-mediated toxicity in primary neurons, either alone or in combination with lecanemab, and, in some conditions, the combination of fosgonimeton and lecanemab led to numerically higher levels of neuroprotection.
- The data support the continued investigation of fosgonimeton and Aβ-mAbs as a potential combination therapy for the treatment of Alzheimer’s disease.
The presentations are available on the Scientific Publications & Presentations page of the company’s website at www.athira.com.
About Fosgonimeton
Fosgonimeton is a potentially first-in-class, once daily, subcutaneously administered small molecule drug candidate. Targeting the protection and repair of neuronal networks, fosgonimeton has disease-modifying potential to address a broad range of neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and dementia with Lewy bodies.
About the Phase 2/3 LIFT-AD Clinical Trial
The Phase 2/3 LIFT-AD clinical trial is a randomized, double-blind, placebo-controlled clinical trial evaluating once-daily subcutaneous injections of fosgonimeton 40 mg compared to placebo in people with mild-to-moderate Alzheimer’s disease. Topline results from the trial, which enrolled approximately 315 patients, is targeted by the end of the third quarter of 2024. The primary endpoint of LIFT-AD is the Global Statistical Test (GST), a combination of the results from the co-key secondary endpoints ADAS-Cog11 and ADCS-ADL23, measurements of cognition and function, respectively. Additional key secondary and exploratory endpoints include changes in plasma biomarkers of neurodegeneration, protein pathology, and neuroinflammation. Additional information about the LIFT-AD study can be found at: NCT04488419.
About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a late 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 therapeutic candidates that modulate the neurotrophic HGF system, including fosgonimeton, which is being evaluated for the potential treatment of mild-to-moderate Alzheimer’s disease in the Phase 2/3 LIFT-AD trial that is targeted to report topline data by the end of the third quarter of 2024. 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, Parkinson’s disease, dementia with Lewy bodies, and other neurodegenerative diseases; future development plans; the anticipated reporting of data; the potential learnings from preclinical studies and other nonclinical data 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 Athira’s ability to advance its drug candidates into later stages of development. 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; the anticipated timing of the topline data from the LIFT-AD trial may be delayed; whether Athira’s trials are sufficiently powered to meet the planned endpoints; 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 expanded drug candidate development and clinical activities on operating expenses; the impact of new or changing laws and regulations; 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
FAQ
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