Full Press Release Details
Alterity Therapeutics to Deliver
Multiple Oral and Poster Presentations at the
International Congress of Parkinson's Disease and Movement Disorders
- Late Breaking Abstract and Oral
Presentation on ATH434-202 Interim Phase 2 Data -
- Oral Presentation on ATH434-201
Phase 2 Baseline Characteristics -
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA - 23 September 2024: 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 multiple oral and poster presentations will be presented at the International
Congress of Parkinson's Disease and Movement Disorders (MDS) taking place September 27 - October 1, 2024 in
"The MDS Congress promises
to be an exceptional medical meeting for Alterity with multiple presentations showcasing our progress this year. Highlights for us include
oral presentations on both of our Phase 2 clinical programs including the acceptance of our late-breaking interim data from our ATH434-202
trial in participants with advanced multiple system atrophy (MSA)," commented, David Stamler, M.D., Chief Executive Officer of Alterity
Late-Breaking Oral Presentation
and Poster on ATH434-202 Interim Data
| Title: | Preliminary Efficacy and Safety of ATH434 in Multiple System Atrophy |
| Lead Author: | Daniel O. Claassen, M.D., M.S., Professor of Neurology, Vanderbilt University Medical Center |
| Abstract: | LBA-18 |
| Session: | Oral Platform Presentation 4 |
| Date/Time: | Saturday, September 28th from 1:30 p.m. - 2:30 p.m. Eastern Time (U.S.) |
| Session: | Poster Presentation: Late-Breaking Abstracts |
| Date/Time: | Daily, September 28 - 30 from 1:00 p.m. 3:00 p.m. Eastern Time (U.S.) |
Oral Presentation and Poster on ATH434-201 Baseline Characteristics
| Title: | A Phase 2 Study of ATH434, a Novel Inhibitor of -Synuclein Aggregation, for the Treatment of Multiple System Atrophy |
| Lead Author: | David Stamler, M.D., Chief Executive Officer of Alterity Therapeutics |
| Abstract: | 4 |
| Session: | Oral Platform Presentation Group 9: Parkinsonisms |
| Date/Time: | Monday, September 30th from 1:30 p.m. - 2:30 p.m. Eastern Time (U.S.) |
| Session: | Poster Presentation: Parkinsonism, Atypical: MSA |
| Date/Time: | Saturday, September 28th from 1:00 p.m. 3:00 p.m. Eastern Time (U.S.) |
| Poster Presentations | |
| Title: | Association Between Clinical Progression in Multiple System Atrophy and Brain Volume Changes Evaluated via Deep Learning Segmentation |
| Lead Author: | Daniel O. Claassen, M.D., M.S., Professor of Neurology, Vanderbilt University Medical Center |
| Session: | Parkinsonism, Atypical: MSA |
| Abstract: | 29 |
| Date/Time: | Saturday, September 28th from 1:00 p.m. 3:00 p.m. Eastern Time (U.S.) |
| Title: | Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in a Parkinson's Disease Model in Macaques |
| Lead Author: | Margaret Bradbury, Vice President, Research and Nonclinical Development, Alterity Therapeutics |
| Session: | Parkinson's Disease: Pharmacology and Therapy |
| Abstract: | 803 |
| Date/Time: | Sunday, September 29th from 1:00 - 3:00 p.m. Eastern Time (U.S.) |
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 -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 ATH434-202 Phase 2 Clinical
The ATH434-202 Phase 2 clinical trial
is an open label study, entitled "A Biomarker Study of ATH434 in Participants with MSA." The Biomarker trial enrolled 10 individuals
with advanced MSA. ATH434-202 study participants will receive treatment with ATH434 for 12-months. The study will assess the effect of
ATH434 treatment on neuroimaging and protein biomarkers to evaluate target engagement, in addition to clinical measures, safety, and pharmacokinetics.
The selected biomarkers, including brain volume, iron and aggregating -synuclein, are important contributors to MSA pathology and
are appropriate targets to demonstrate drug activity. The primary objective of this study is to evaluate the impact of 12 months treatment
with ATH434 on brain volume in a more advanced patient population than is being studied in Alterity's randomized Phase 2 trial.
Final, 12-month data from the ATH434-202 trial are expected in the first half of 2025. Additional information on the open label Phase
2 trial can be found at clinicaltrials.gov identifier: NCT05864365.
About ATH434-201 Phase 2 Clinical
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 -synuclein,
are important contributors to MSA pathology and are therefore appropriate targets to demonstrate drug activity. Wearable sensors have
also been 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 will receive 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.
Biomarkers of progression in Multiple System
Atrophy (bioMUSE) is a natural history study that aims to track the progression of individuals with MSA, a parkinsonian disorder
without approved therapy. The study is being conducted in collaboration with Vanderbilt University Medical Center in the U.S. under
the direction of Daniel Claassen, M.D., M.S., Professor of Neurology and Principal Investigator. Natural history studies are
important for characterizing disease progression in selected patient populations. The study has provided rich data for optimizing
the design of Alterity's randomized ATH434-201 Phase 2 clinical trial and enrolled approximately 20 individuals with
clinically probable or clinically established MSA. BioMUSE continues to provide vital information on early stage MSA patients,
informs the selection of biomarkers suitable to evaluate target engagement and preliminary efficacy, and delivers clinical data to
characterize disease progression in a patient population that mirrors those currently enrolling in the Phase 2 clinical trial.
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 -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
About Parkinson's Disease
Parkinson's disease (PD) is the
second most common neurodegenerative disorder and causes unintended or uncontrollable movements of the body along with neuropsychiatric
and other nonmotor features. The precise cause of PD is unknown, but some cases are hereditary while others are thought to occur from
a combination of genetics and environmental factors that trigger the disease. In PD, brain cells become damaged or die in the substantia
nigra, the part of the brain that produces dopamine--a chemical needed to produce smooth, purposeful movement. The cardinal symptoms of
PD are tremors, rigidity, slowing of movements, and later in disease, impaired balance. Other symptoms may include difficulty swallowing,
chewing, or speaking; emotional changes; urinary problems or constipation; dementia or other cognitive problems; fatigue; and problems
sleeping.2 Nearly one million people in the U.S. and more than 10 million people worldwide are living with PD. Approximately
60,000 Americans are diagnosed with PD each year.3
| 1 | Multiple System Atrophy | National Institute of Neurological Disorders and Stroke (nih.gov) |
| 2 | National Institute of Health: Neurological Disorders and Stroke, Parkinson's Disease Information Page; |
| 3 | Parkinson's Foundation |
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:
Remy Bernarda remy.bernarda@iradvisory.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.