Alterity Therapeutics Announces Successful Completion of Phase 1 Clinical Trial
July 29 2019 - 8:00AM
Business Wire
Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE)
(“Alterity” or “the Company”) today announced that it has
successfully completed its Phase 1 study of PBT434, a novel, orally
bioavailable small molecule inhibitor of alpha- synuclein
aggregation.
Alpha-synuclein, when aggregated in the brain, is a pathological
hallmark of Parkinsonian conditions and is considered an important
biologic target for treating these neurodegenerative diseases.
The completed trial, which now includes data from elderly
volunteers receiving repeated doses, continues to demonstrate that
the drug was safe and well-tolerated, with adverse event rates
comparable to placebo. It builds on the data from healthy
volunteers announced in May 2019 at the American Academy of
Neurology Annual Meeting.
Systemic exposure to the drug was comparable between elderly and
healthy volunteers. This information, along with previous results
in the Phase 1 study, indicate that clinically tested doses achieve
concentrations in the brain that are comparable with those
associated with efficacy in animal models of disease.
As was observed in healthy adult volunteers, no elderly subject
experienced a serious adverse event or an adverse event that led to
discontinuation of the study drug.
Dr David Stamler, Chief Medical Officer and Senior VP Clinical
Development, said: “We are very pleased that the excellent safety
and tolerability profile in the adult population has now been
extended to elderly volunteers. These data will provide the
foundation for our interactions with regulatory authorities later
this year as we advance the program toward a Phase 2 clinical
trial.”
PBT434 is an oral small molecule drug candidate with potential
for treating synucleinopathies such as Parkinson disease and
Multiple system atrophy, a form of atypical Parkinsonism. Multiple
system atrophy is a rare and rapidly progressive neurological
disorder affecting adults. PBT434 was granted Orphan designation by
the U.S. FDA earlier this year for the treatment of Multiple system
atrophy.
The Phase 1 Clinical Trial for PBT434 recruited healthy adult
and elderly (≥ 65) volunteers with the primary goals of assessing
the safety and tolerability of PBT434 after single and multiple
oral dose administration. Secondary goals included evaluating
pharmacokinetics in plasma and cerebrospinal fluid that enabled
determination of how PBT434 is absorbed and metabolized by the
body.
PBT434 is the first of a new generation of small molecules
designed to block the accumulation and aggregation of α-synuclein.
Alterity is already in the preparatory phase of planning for Phase
2 clinical trial and will provide further updates to the market in
the coming months.
Investor enquiries IR@alteritytherapeutics.com
About Alterity Therapeutics Limited
Alterity’s lead candidate, PBT434, is the first of a new
generation of small molecules designed to inhibit the aggregation
of pathological proteins implicated in neurodegeneration. PBT434
has been shown to reduce abnormal accumulation of α-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 Multiple
System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP).
For further information please visit the Company’s web site at
www.alteritytherapeutics.com.
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,
PBT434, 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, PBT434, 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,
PBT434, that could slow or prevent products coming to market, the
uncertainty of patent protection for the Company's intellectual
property or trade secrets, including, but not limited to, the
intellectual property relating to PBT434.
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 updated 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.
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Investor Relations Rebecca Wilson or Dylan Mark E:
alterity@we-buchan.com Tp: +61 3 9866 4722
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