Alterity Therapeutics Limited Received European Union Regulatory Guidance For Phase 2 Clinical Trial ATH434
- Alterity receives positive advice from the European Medicines Agency’s Committee for Medicinal Products for Human Use on its Phase 2 clinical trial for multisystem atrophy.
- Alignment with Alterity’s plan to target patients with early stage MSA.
- Approval of the selection of biomarker assessment criteria to assess the pathological characteristics of the MSA.
- Agreement that ATH434 has potential as a disease modifying treatment.
Melbourne, Australia and SAN FRANCISCO, June 23, 2021 / PRNewswire / – Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) (âAlterityâ or âthe Companyâ) Received Advice from the European Medicines Agency (EMA) regarding key aspects of the Company’s Phase 2 clinical trial for the investigational drug ATH434 for the treatment of multisystem atrophy (MSA).
Alterity is actively preparing for the launch of its Phase 2 trial which is expected to begin within 2 hours of this calendar year. EMA is the European Union agency responsible for the evaluation and monitoring of medicines. Specifically, EMA plays an important role in supporting the timely and robust development of high quality, effective and safe medicines for the benefit of patients. While their advice is not binding, it does have the advantage of influencing improved trial designs that are more likely to generate strong and comprehensive data to show whether a treatment works and is safe.
Since there is no approved treatment for MSA, there is currently no regulatory precedent to define the most appropriate patient population or clinical endpoints in efficacy studies, which requires further consideration. greater consideration when developing an optimal test design. As a result, Alterity solicited various contributions from clinical experts and global regulatory authorities, and is conducting a natural history study, called BioMUSE, to identify the biomarkers and clinical endpoints best suited to capture the signals. efficacy in the phase 2 study.
The EMA has supported Alterity’s intention to enroll patients with early stage MSA and use biomarkers to accurately diagnose these patients prior to enrollment. Improving diagnostic accuracy and targeting patients at an early stage will allow Alterity to maximize the opportunity to demonstrate the efficacy of ATH434, its potentially disease-modifying treatment.
ATH434 is the first in a new generation of small molecule drug candidates designed to block the accumulation and aggregation of Î±-synuclein. Alpha-synuclein, when aggregated in the brain, is a pathological feature of parkinsonian disorders such as MSA and is considered an important biological target for the treatment of these neurodegenerative diseases. ATH434 is believed to exert its biological effect on-synuclein by binding and redistributing excess iron in pathological areas. The EMA recognized the potential role of iron in the pathogenesis of MSA and therefore supported the use of biomarker parameters to assess iron content and pathogenesis of Î±-synuclein.
Following interactions with the EMA, and previously with the United States Food and Drug Administration (FDA), Alterity is finalizing the design of its Phase 2 trial, including patient selection, patient size sample, duration of treatment, and primary and secondary endpoints.
In addition, the bioMUSE natural history study conducted at Vanderbilt University Medical Center in the United States, has recruited over 50% of targeted patients and continues to collect clinical data and vital biomarkers to inform the design of the Phase 2 study.
Dr Alterity CEO David stamler said, “MSA is a devastating disease with no cure and few effective treatment options. Thanks to the valuable advice received from the EMA, we now have a clear path to finalize the study design and generate data that global regulatory authorities are researching. This is another important step towards providing much needed disease-modifying therapies for people with ASD. “
Authorization & additional information
This ad has been authorized by David stamler, CEO of Alterity Therapeutics Limited.
About Alterity Therapeutics Limited and ATH434
Alterity’s lead candidate, ATH434, is the first in a new generation of small molecules designed to inhibit the aggregation of pathological proteins involved in neurodegeneration. ATH434 has been shown to reduce the abnormal accumulation of Î±-synuclein and tau proteins in animal models of disease by restoring normal iron balance in the brain. In this way, it has excellent potential to treat various forms of atypical parkinsonism such as multisystem atrophy (MSA) and progressive supranuclear palsy (PSP).
ATH434 has received orphan designation for the treatment of MSA by the US FDA and the European Commission.
For more information, please visit the company’s website at www.alteritytherapeutics.com.
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 attempted to identify such forward-looking statements by using such words. that “expects”, “intends to”, “hopes”, “anticipates”, “believes”, “could”, “could”, “evidence” and “estimates” and other expressions similar, 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 these forward-looking statements are described in the sections headed “Risk factors“ in the society‘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: statements relating to the development program of the Company’s drugs, including, but to the initiation, advancement and clinical trial results of the Company’s drug development program, including, but not limited to ATH434, and any other statements that are not historical facts. These statements involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to difficulties or delays in the financing, development, testing, regulatory approval, production and marketing of the society‘s drug components including, but not limited to ATH434, uncertainties regarding the impact of the novel coronavirus (COVID-19) pandemic on the company’s business, operations and employees , the Company’s ability to secure additional future sources of funding, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to ATH434, which could slow or prevent the marketing of products, the uncertainty of patent protection of the Company’s intellectual property or trade secrets, including, but not limited to, intellectual property relating to ATH434.
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SOURCE Alterity Therapeutics Limited