MELBOURNE, Australia AND SAN FRANCISCO–(BUSINESS WIRE)–Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) (“Alterity” or
“the Company”) is today releasing interim clinical data of its Phase 1
clinical trial program for its investigative drug PBT434 at the American
Academy of Neurology Annual Meeting in Philadelphia, USA.
The Platform Presentation titled: A
First in Human Study of PBT434, a Novel Small Molecule Inhibitor of
α-Synuclein Aggregation is being delivered by David Stamler, MD,
Chief Medical Officer & Senior VP Clinical Development. The American
Academy of Neurology Annual Meeting is one of the largest gatherings of
clinicians and researchers focusing on neurology in the world.
The study is expected to complete mid-2019, however Alterity has been
invited to present interim data from the initial four single dose
cohorts and the initial three multiple dose cohorts. The data being
released indicate that PBT434 was well tolerated with adverse event
rates comparable to placebo and dose dependent systemic exposure
following oral administration.
Importantly, the results indicate that PBT434 not only crosses the blood
brain barrier in humans, confirming previous observations in animal
studies, but that clinically tested doses achieve concentrations in the
brain that exceed those associated with efficacy in animal models of
disease.
No serious adverse events were reported and no subject discontinued
dosing with PBT434 due to adverse events.
Dr David Stamler said: “The notable finding from this study is that
PBT434 penetrates into the human brain and achieves concentrations that
are potentially clinically relevant at doses that were well tolerated in
healthy volunteers. We are very encouraged by these results which
represent an important step in the advancement of PBT434. We look
forward to providing final data at a medical conference later this year.”
PBT434 is an oral small molecule drug candidate with potential for
treating synucleinopathies such as Parkinson’s Disease and Multiple
System Atrophy, a rare and rapidly progressive neurological disorder
that affects adults.
The Phase 1 Clinical Trial for PBT434 commenced in 2018 in Australia,
recruiting healthy adult and older adult (≥ 65) volunteers with the
primary goals of assessing the safety and tolerability of PBT434 after
single and multiple oral dose administration. Secondary goals include
evaluating pharmacokinetic measures that will allow Alterity understand
how PBT434 is absorbed and metabolised by the body.
PBT434 is the first of a new generation of small molecules designed to
block the accumulation and aggregation of α-synuclein. α-synuclein
is of great interest because aggregated forms of the protein are
considered a pathological hallmark of Parkinsonian conditions and are a
recognised therapeutic target by neuroscientists and clinici
End Note
The Company changed its name on 8 April 2019 from Prana Biotechnology
Limited to Alterity Therapeutics Limited, (ASX: ATH, NASDAQ:ATHE).
Investor enquiries IR@altertitytherapeutics.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
Contacts
Investor Relations
Rebecca Wilson
E: rwilson@buchanwe.com.au
Tp:
+61 3 9866 4722