Alterity Therapeutics Issues Shareholder Letter Highlighting Pipeline Advances and Key Upcoming Milestones
Alterity Therapeutics (NASDAQ: ATHE) has issued a shareholder letter highlighting significant progress in 2024 and upcoming milestones for 2025. The company completed a 12-month, double-blind Phase 2 clinical trial of ATH434 in early-stage Multiple System Atrophy (MSA), with topline data expected in late January or early February.
Preliminary results from their open-label biomarker study in advanced MSA patients showed stable or improved clinical measures after 6-months of ATH434 treatment. The study demonstrated stable iron levels and brain volumes in clinical responders, along with reduced neuronal injury compared to untreated patients.
The company also presented preclinical data showing ATH434's potential in a primate model of Parkinson's disease. Their bioMUSE Natural History study, in collaboration with Vanderbilt University Medical Center, led to developing a novel imaging biomarker for assessing brain volume in MSA-affected regions.
Alterity Therapeutics (NASDAQ: ATHE) ha inviato una lettera agli azionisti evidenziando i progressi significativi nel 2024 e le prossime pietre miliari per il 2025. L'azienda ha completato uno studio clinico di Fase 2 in doppio cieco della durata di 12 mesi su ATH434, per la sindrome da atrofia sistemica multipla (MSA) in fase iniziale, con i dati preliminari attesi a fine gennaio o inizio febbraio.
I risultati preliminari del loro studio sui biomarcatori in aperto su pazienti con MSA avanzata hanno mostrato misure cliniche stabili o migliorate dopo 6 mesi di trattamento con ATH434. Lo studio ha dimostrato livelli di ferro e volumi cerebrali stabili nei rispondenti clinici, insieme a una riduzione del danno neuronale rispetto ai pazienti non trattati.
L'azienda ha anche presentato dati preclinici che mostrano il potenziale di ATH434 in un modello primate della malattia di Parkinson. Il loro studio bioMUSE di Storia Naturale, in collaborazione con il Vanderbilt University Medical Center, ha portato allo sviluppo di un nuovo biomarcatore di imaging per valutare il volume cerebrale nelle regioni colpite dalla MSA.
Alterity Therapeutics (NASDAQ: ATHE) ha emitido una carta a los accionistas destacando el progreso significativo en 2024 y los próximos hitos para 2025. La compañía completó un ensayo clínico de Fase 2, doble ciego, de 12 meses sobre ATH434 en la Atrofia Sistemática Múltiple (MSA) en etapa temprana, con datos preliminares esperados a finales de enero o principios de febrero.
Los resultados preliminares de su estudio de biomarcadores abierto en pacientes con MSA avanzada mostraron medidas clínicas estables o mejoradas después de 6 meses de tratamiento con ATH434. El estudio demostró niveles de hierro y volúmenes cerebrales estables en los respondedores clínicos, junto con una reducción del daño neuronal en comparación con los pacientes no tratados.
La compañía también presentó datos preclínicos que muestran el potencial de ATH434 en un modelo de primate de la enfermedad de Parkinson. Su estudio bioMUSE de Historia Natural, en colaboración con el Vanderbilt University Medical Center, llevó al desarrollo de un nuevo biomarcador de imagen para evaluar el volumen cerebral en las regiones afectadas por MSA.
Alterity Therapeutics (NASDAQ: ATHE)는 2024年의 주요 진전 사항과 2025年의 예정된 마일스톤을 강조한 주주 서한을 발표했습니다. 이 회사는 초기 단계의 다계통 위축(MSA)을 위한 ATH434의 12개월 이중 맹검 2상 임상 시험을 완료했으며, 주요 데이터는 1월 말 또는 2월 초에 발표될 예정입니다.
고급 MSA 환자를 대상으로 실시한 공개 라벨 생체표지자 연구의 초기 결과는 ATH434 치료 후 6개월 동안 임상 지표가 안정적이거나 개선되었음을 보여주었습니다. 이 연구는 임상 반응자에서 안정적인 철분 수치와 뇌 용적을 보였으며, 치료받지 않은 환자와 비교하여 신경 손상이 감소했습니다.
회사는 또한 ATH434의 잠재력을 파킨슨병의 영장류 모델에서 보여주는 전임상 데이터를 발표했습니다. Vanderbilt University Medical Center와 협력한 bioMUSE 자연사 연구는 MSA 영향을 받는 지역에서의 뇌 용적 평가를 위한 새로운 이미징 생체표지자를 개발하는 것으로 이어졌습니다.
Alterity Therapeutics (NASDAQ: ATHE) a publié une lettre aux actionnaires soulignant des progrès significatifs en 2024 et les prochaines étapes pour 2025. La société a achevé un essai clinique de Phase 2 à double insu de 12 mois sur ATH434 dans la Sclérose Systémique Multiple (MSA) à un stade précoce, avec des données préliminaires attendues fin janvier ou début février.
Les résultats préliminaires de leur étude sur les biomarqueurs ouverte chez des patients atteints de MSA avancée ont montré des mesures cliniques stables ou améliorées après 6 mois de traitement par ATH434. L'étude a démontré des niveaux de fer et des volumes cérébraux stables chez les répondants cliniques, ainsi qu'une réduction des dommages neuronaux par rapport aux patients non traités.
La société a également présenté des données précliniques montrant le potentiel d'ATH434 dans un modèle de primate de la maladie de Parkinson. Leur étude bioMUSE sur l'Histoire Naturelle, en collaboration avec le Vanderbilt University Medical Center, a conduit au développement d'un nouveau biomarqueur d'imagerie pour évaluer le volume cérébral dans les régions affectées par la MSA.
Alterity Therapeutics (NASDAQ: ATHE) hat einen Aktionärsbrief veröffentlicht, der erhebliche Fortschritte im Jahr 2024 und bevorstehende Meilensteine für 2025 hervorhebt. Das Unternehmen hat eine 12-monatige, doppelblinde Phase-2-Studie zu ATH434 bei der frühen multiplen Systematrophie (MSA) abgeschlossen, mit ersten Ergebnissen, die Ende Januar oder Anfang Februar erwartet werden.
Vorläufige Ergebnisse aus ihrer offenen Biomarker-Studie an Patienten mit fortgeschrittener MSA zeigten stabile oder verbesserte klinische Maße nach 6-monatiger Behandlung mit ATH434. Die Studie zeigte stabile Eisenwerte und Gehirnvolumina bei klinischen Ansprechern sowie reduzierte neuronale Schäden im Vergleich zu unbehandelten Patienten.
Das Unternehmen präsentierte auch präklinische Daten, die das Potenzial von ATH434 in einem Primatenmodell der Parkinson-Krankheit zeigen. Ihre bioMUSE-Studie zur Naturgeschichte, in Zusammenarbeit mit dem Vanderbilt University Medical Center, führte zur Entwicklung eines neuartigen bildgebenden Biomarkers zur Bewertung des Gehirnvolumens in MSA-betroffenen Regionen.
- Completion of Phase 2 clinical trial for ATH434 in MSA with imminent topline data
- Positive preliminary results from open-label biomarker study showing clinical improvements
- Development of novel imaging biomarker for MSA through bioMUSE study
- Promising preclinical data for ATH434 in Parkinson's disease model
- None.
Insights
The shareholder letter outlines significant clinical developments for Alterity Therapeutics' lead candidate ATH434 in Multiple System Atrophy (MSA). Two key milestones stand out: completion of a 12-month Phase 2 clinical trial with topline data expected in early 2025 and preliminary results from an open-label biomarker study showing stable or improved clinical measures in advanced MSA patients.
The biomarker study results are particularly noteworthy, demonstrating stable iron levels and brain volumes in clinical responders, along with reduced neuronal injury compared to untreated patients. This provides important validation of ATH434's mechanism of action and potential efficacy. For a rare neurodegenerative disease like MSA with no current disease-modifying treatments, these early signals of biological activity could be significant for both patients and investors.
The expansion into Parkinson's disease through preclinical primate studies suggests broader therapeutic potential beyond MSA, significantly expanding the drug's commercial opportunity. The novel imaging biomarker development through the bioMUSE study also strengthens the company's clinical development toolkit, potentially enabling more precise measurement of treatment effects in future trials.
From a market perspective, Alterity's strategic focus on MSA represents a calculated entry into an underserved market. MSA is an orphan indication with no approved disease-modifying treatments, potentially allowing for expedited regulatory pathways and premium pricing if ATH434 proves successful. The dual Phase 2 readouts expected in 2025 represent major catalysts that could significantly impact the company's
The expansion into Parkinson's disease is strategically sound, as it represents a much larger market opportunity while leveraging the same mechanism of action. The collaboration with Vanderbilt University Medical Center adds credibility and demonstrates the company's ability to forge valuable academic partnerships. However, investors should note that as a small-cap biotech, Alterity will likely need additional funding to advance their programs through later-stage clinical development, particularly if they pursue both MSA and Parkinson's indications.
MELBOURNE, Australia and SAN FRANCISCO, Jan. 09, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today issued a letter to shareholders.
Dear Valued Shareholders:
As we again begin a new year, I am filled with optimism for 2025 and what lies ahead for Alterity Therapeutics.
I want to express my sincere gratitude for your unwavering support and belief in our mission to develop disease-modifying therapies for those living with neurodegenerative diseases. Your investment in Alterity allows us to pursue groundbreaking research and bring hope to patients and families affected by these devastating conditions.
2024 was a year of significant progress for Alterity. Most prominently, we completed our 12-month, double-blind Phase 2 clinical trial of ATH434 in early-stage Multiple System Atrophy (MSA). This milestone leads us to a topline data readout expected in late January or early February. Last July, we were pleased to report encouraging preliminary results from our open-label biomarker study in individuals with more advanced MSA.
The preliminary results from the open-label study showed that individuals receiving 6-months treatment with ATH434 had stable or improved clinical measures and that this clinical benefit was supported by biomarker data: stable iron levels and brain volumes in clinical responders and reduced neuronal injury compared to untreated patients from our MSA natural history study. Taken together, these data provide strong support for the potential of ATH434 to slow the progression of this very aggressive disease.
In addition to our advancements in clinical studies, we also continue to generate compelling data in MSA and other neurological diseases. Last year, we presented promising preclinical data demonstrating the potential of ATH434 in a primate model of Parkinson's disease. Our bioMUSE Natural History study, in collaboration with Professor Daniel Claassen’s neuroimaging group at Vanderbilt University Medical Center, yielded valuable insights into MSA progression and led to the development of a novel imaging biomarker for assessing brain volume in regions affected by MSA.
This year promises to be pivotal for Alterity with topline data expected from both of our Phase 2 clinical trials in MSA. Our team remains steadfast in their dedication to advancing our research and development efforts and bringing innovative therapies to patients with neurodegenerative diseases.
Thank you for your continued interest and support and we look forward to keeping you updated on our progress.
David Stamler, M.D., Chief Executive Officer of Alterity.
About Alterity Therapeutics Limited
Alterity Therapeutics is a clinical stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company’s lead asset, ATH434, has the potential to treat various Parkinsonian disorders and is currently being evaluated in two Phase 2 clinical trials in Multiple System Atrophy. Alterity also has a broad drug discovery platform generating patentable chemical compounds to treat the underlying pathology of neurological diseases. The Company is based in Melbourne, Australia, and San Francisco, California, USA. For further information please visit the Company’s web site at www.alteritytherapeutics.com.
Authorisation & Additional information
This announcement was authorized by David Stamler, CEO of Alterity Therapeutics Limited.
Investor and Media Contacts:
Australia
Ana Luiza Harrop
we-aualteritytherapeutics@we-worldwide.com
+61 452 510 255
U.S.
Remy Bernarda
remy.bernarda@iradvisory.com
+1 (415) 203-6386
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements.
Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled “Risk Factors” in the Company’s filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company's drug development program, including, but not limited to, ATH434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, ATH434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited to, ATH434, that could slow or prevent products coming to market, the uncertainty of obtaining patent protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company’s patent rights and the uncertainty of the Company freedom to operate.
Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
FAQ
When will Alterity (ATHE) release Phase 2 topline data for ATH434 in MSA?
What were the results of ATHE's open-label biomarker study for ATH434?
What new developments did ATHE achieve in their bioMUSE Natural History study?
What additional therapeutic potential has ATHE shown for ATH434?
