MELBOURNE, Australia and
SAN FRANCISCO, June 29, 2020 /PRNewswire/ -- Alterity
Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company")
is pleased to announce that it has received guidance from the US
Food and Drug Administration (FDA) in relation to the development
pathway for ATH434 (previously PBT434), the company's lead compound
for the treatment of Multiple System Atrophy (MSA), a Parkinsonian
disorder.
The company recently met with the FDA following the successful
completion of its Phase 1 clinical trial last year and further data
analysis. The pre-IND (Investigational New Drug) meeting was to
obtain input on the clinical development plan for ATH434, including
feedback on the Phase 2 study design.
Alterity reached agreement with the FDA on the non-clinical
investigations required to support the Phase 2 study. In addition,
the FDA agreed to key aspects of the Company's Phase 2 study design
including the proposed patient population, safety monitoring plan,
and strategy for evaluating drug exposure during the study.
As there are currently no approved treatments for MSA and,
therefore, no regulatory precedent regarding accepted efficacy
endpoints, the FDA and Alterity will work together to develop an
endpoint that is best suited for the MSA patients to be studied.
The FDA has also encouraged Alterity to utilise data from a natural
history study that Alterity has planned with clinical and
neuroimaging experts at Vanderbilt
University Medical Center in the US.
This natural history study, referred to as bioMUSE, or
biomarkers of Progression in Multiple System Atrophy, will enroll
early stage MSA patients and track change in clinical parameters
and biomarkers for up to one year. Natural history studies are
important for characterizing disease progression over time in
selected patient populations. Well-conducted, these studies can
provide vital information to optimize clinical trial design and
inform the selection of biomarkers to evaluate target engagement of
drug candidates.
In parallel with the US strategy, Alterity is also pursuing a
regulatory pathway in Europe and
Australia. Given the uncertainty
of study conduct and recruitment in the COVID-19 era, and with the
need to target sites that are minimally impacted, it is prudent for
the Company to be flexible in identifying and recruiting sites
around the world and maintaining optionality. Planning is already
underway to meet with European authorities.
Dr David Stamler, Chief Medical
Officer, said: "The FDA clearly recognizes the seriousness of MSA
and the need for new treatments to address this devastating Orphan
disease. Our pre-IND meeting was very collegial, and I look forward
to again collaborating with the Division of Neurology to determine
the best development path for ATH434 in the US. With the
information obtained from this meeting, we have a clear path
forward for conducting our Phase 2 study in MSA."
END
Authorization & Additional information
This announcement was authorized by Geoffrey Kempler, CEO and Chairman of Alterity
Therapeutics Limited.
Contact:
Investor Relations
Rebecca Wilson, WE
Communications
E: WE-AUAlterity@we-worldwide.com
Tp: +61 3 8866 1216
View original
content:http://www.prnewswire.com/news-releases/alterity-therapeutics-meeting-with-us-fda-provides-development-pathway-for-ath434-301085507.html
SOURCE Alterity Therapeutics