Alterity Therapeutics Completes Last Patient Visit in ATH434-201 Phase 2 Clinical Trial in Early-Stage Multiple System Atrophy
Alterity Therapeutics has announced the completion of the last patient visit in its ATH434-201 Phase 2 clinical trial for early-stage multiple system atrophy (MSA). The trial, which is a randomized, double-blind, placebo-controlled study, evaluates ATH434, a disease-modifying drug candidate targeting alpha-synuclein and iron in Parkinsonian disorders.
The company expects to report topline results in late January or early February 2025. This milestone marks the beginning of the final phase, which includes database cleaning and locking before the release of results. The study has garnered significant interest from clinical sites, doctors, and patients globally in the pursuit of a treatment that could potentially slow MSA progression.
Alterity Therapeutics ha annunciato il completamento dell'ultima visita del paziente nel suo studio clinico di fase 2 ATH434-201 per l'atrofia multisistemica (MSA) in fase precoce. Lo studio, che è un trial randomizzato, in doppio cieco e controllato con placebo, valuta ATH434, un candidato farmaco modificante la malattia che mira all'alfa-sinucleina e al ferro nei disturbi parkinzoniani.
La società prevede di riportare risultati preliminari entro la fine di gennaio o inizio febbraio 2025. Questo traguardo segna l'inizio della fase finale, che comprende la pulizia e il blocco del database prima della diffusione dei risultati. Lo studio ha suscitato un notevole interesse da parte di centri clinici, medici e pazienti a livello globale nella ricerca di un trattamento che potrebbe potenzialmente rallentare la progressione della MSA.
Alterity Therapeutics ha anunciado la finalización de la última visita del paciente en su ensayo clínico de fase 2 ATH434-201 para la atrofia multisistémica (MSA) en etapas tempranas. El ensayo, que es un estudio aleatorizado, doble ciego y controlado con placebo, evalúa ATH434, un candidato a medicamento modulador de la enfermedad que apunta a la alfa-sinucleína y al hierro en trastornos parkinsonianos.
La compañía espera informar los resultados preliminares a finales de enero o principios de febrero de 2025. Este hito marca el inicio de la fase final, que incluye la limpieza y el cierre de la base de datos antes de la divulgación de resultados. El estudio ha generado un interés significativo por parte de sitios clínicos, médicos y pacientes a nivel mundial en la búsqueda de un tratamiento que potencialmente podría ralentizar la progresión de la MSA.
Alterity Therapeutics는 초기 다계통 위축증(MSA)을 위한 ATH434-201 임상 2기 시험의 마지막 환자 방문 완료를 발표했습니다. 이 시험은 무작위, 이중 맹검, 위약 대조 연구로, 파킨슨계 질환의 알파-신클레인과 철을 표적한 질병 수정 약물 후보인 ATH434를 평가합니다.
회사는 2025년 1월 말 또는 2월 초에 주요 결과를 보고할 것으로 예상하고 있습니다. 이 이정표는 결과 발표 전에 데이터베이스 정리 및 잠금을 포함하는 마지막 단계의 시작을 의미합니다. 이 연구는 MSA 진행 속도를 잠재적으로 늦출 수 있는 치료법을 찾는 데 있어 전 세계의 클리닉, 의사 및 환자들로부터 상당한 관심을 받고 있습니다.
Alterity Therapeutics a annoncé l'achèvement de la dernière visite d'un patient dans son essai clinique de phase 2 ATH434-201 pour l'atrophie multisystémique (MSA) à un stade précoce. L'essai, qui est une étude randomisée, en double aveugle et contrôlée par placebo, évalue ATH434, un candidat médicament modifiant la maladie ciblant l'alpha-synucléine et le fer dans les troubles parkinsoniens.
L'entreprise s'attend à divulguer les résultats préliminaires d'ici fin janvier ou début février 2025. Ce jalon marque le début de la phase finale, qui comprend le nettoyage et le verrouillage de la base de données avant la publication des résultats. L'étude a suscité un intérêt considérable de la part des sites cliniques, des médecins et des patients dans le monde entier à la recherche d'un traitement qui pourrait potentiellement ralentir la progression de la MSA.
Alterity Therapeutics hat den Abschluss des letzten Patientenbesuchs in seiner ATH434-201 Phase 2-Studie zur frühen multiplen Systematrophie (MSA) bekannt gegeben. Die Studie, die ein randomisiertes, doppelblinder, placebokontrolliertes Verfahren ist, bewertet ATH434, einen krankheitsmodifizierenden Wirkstoffkandidaten, der sich gezielt auf Alpha-Synuklein und Eisen bei parkinsonschen Störungen konzentriert.
Das Unternehmen erwartet, Endergebnisse Ende Januar oder Anfang Februar 2025 zu berichten. Dieser Meilenstein markiert den Beginn der letzten Phase, die die Bereinigung und Sperrung der Datenbank vor der Veröffentlichung der Ergebnisse umfasst. Die Studie hat erhebliches Interesse von klinischen Einrichtungen, Ärzten und Patienten weltweit geweckt, in der Suche nach einer Behandlung, die möglicherweise das Fortschreiten der MSA verlangsamen könnte.
- Successful completion of Phase 2 clinical trial patient visits
- On track for topline data release in early 2025
- Strong interest from clinical sites and medical community
- None.
Insights
The completion of the Phase 2 clinical trial for ATH434 marks a significant milestone in the development of treatments for Multiple System Atrophy (MSA). This trial represents a important step in evaluating a potential first-in-class disease-modifying treatment targeting both alpha-synuclein and iron accumulation in MSA patients. The double-blind, placebo-controlled design adds scientific rigor to the study, while the focus on early-stage MSA patients is strategically important for assessing disease modification potential.
The expected topline data in early 2025 will be pivotal in determining ATH434's efficacy in slowing MSA progression. For a small-cap company (
This development represents a critical value inflection point for Alterity Therapeutics. With a market cap of only
The early 2025 data readout provides a clear catalyst timeline for investors. Given the company's small market cap, any positive efficacy signals could attract partnership interest from larger pharmaceutical companies seeking to expand their neurology portfolios. However, investors should consider the binary nature of clinical trial results and the company's pipeline diversity when assessing investment risks.
– ATH434 is a Disease Modifying Drug Candidate Targeting Alpha-Synuclein and Iron in Parkinsonian Disorders –
– Topline Data Expected in Early 2025 –
MELBOURNE, Australia and SAN FRANCISCO, Dec. 04, 2024 (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 announced that the last patient in the ATH434-201 Phase 2 trial, a randomized, double-blind, placebo-controlled investigation in early-stage multiple system atrophy (MSA), has completed the study. With the achievement of this milestone, topline results are expected to be reported in late January or early February 2025.
“We are very excited to announce that the last participant in our Phase 2 study has completed all clinical evaluations, the final milestone that starts the clock to reporting topline data in this rare neurodegenerative disease,” said, David Stamler, M.D., Chief Executive Officer of Alterity. “The completion of our ATH434-201 trial represents a major accomplishment for Alterity, and I would like to recognize the trial participants for their involvement in the study. I would also like to thank our clinical sites and our study team for their hard work and dedication in conducting the trial. Throughout the course of the trial, we have had tremendous interest from our clinical sites, doctors and patients around the globe as we seek a treatment that could potentially slow the progression of this devastating disease. With the last patient visit behind us, we can now focus our attention on cleaning and locking the database and reporting topline data early next year.”
About ATH434-201 Phase 2 Clinical Trial
The ATH434-201 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of ATH434 in patients with early-stage MSA. The study will evaluate the effect of ATH434 treatment on neuroimaging and protein biomarkers to demonstrate target engagement and clinical endpoints to demonstrate efficacy, in addition to assessments of safety and pharmacokinetics. Selected biomarkers, such as brain iron and aggregating α-synuclein, are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity. Wearable sensors were also employed to evaluate motor activities that are important to patients with MSA. The study enrolled 77 adults who were randomly assigned to receive one of two dose levels of ATH434 or placebo. Participants received treatment for 12 months which will provide an opportunity to detect changes in efficacy endpoints to optimize design of a definitive Phase 3 study. Additional information on the Phase 2 trial can be found by ClinicalTrials.gov Identifier: NCT05109091.
About ATH434
Alterity’s lead candidate, ATH434, is an oral agent designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve neuronal function by restoring normal iron balance in the brain. As an iron chaperone, it has excellent potential to treat Parkinson’s disease as well as various Parkinsonian disorders such as Multiple System Atrophy (MSA). ATH434 successfully completed Phase 1 studies demonstrating the agent is well tolerated and achieved brain levels comparable to efficacious levels in animal models of MSA. ATH434 is currently being studied in two clinical trials: Study ATH434-201 is a randomized, double-blind, placebo-controlled Phase 2 clinical trial in patients with early-stage MSA and Study ATH434-202 is an open-label Phase 2 Biomarker trial in patients with more advanced MSA. ATH434 has been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission.
About Multiple System Atrophy
Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease and causes profound disability. MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and/or rigidity, autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control, and impaired balance and/or coordination that predisposes to falls. A pathological hallmark of MSA is the accumulation of the protein α-synuclein within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions. MSA affects at least 15,000 individuals in the U.S., and while some of the symptoms of MSA can be treated with medications, currently there are no drugs that are able to slow disease progression and there is no cure.1
1Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov)
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 Therapeutics (ATHE) release topline data for the ATH434-201 Phase 2 trial?
What is the purpose of Alterity Therapeutics' ATH434 drug candidate?
What type of clinical trial is ATH434-201?
