Acer Therapeutics Announces University of North Carolina Receives Department of Defense Grant to Support the Proposed Investigator Sponsored OASIS Trial of ACER-801 (Osanetant) to Reduce the Frequency and Severity of Post-Traumatic Stress Disorder
October 06 2022 - 8:30AM
Acer Therapeutics Inc. (Nasdaq: ACER), a clinical stage
pharmaceutical company focused on the acquisition, development and
commercialization of therapies for serious rare and
life-threatening diseases with significant unmet medical needs,
today announced that the University of North Carolina (UNC)
Institute for Trauma Recovery has been awarded a $3 million grant
from the Department of Defense (DoD) to investigate the potential
of ACER-801 (osanetant) to reduce the frequency and severity of
acute stress disorder and post-traumatic stress disorder (PTSD).
Acute stress disorder refers to the body’s immediate response to
trauma, whereas PTSD is the long-term effects of trauma.
“Historically, we have been able to provide emergency care to
address immediate and long-term problems after visible wounds using
tools such as sutures and antibiotics. However, we still have
nothing to offer trauma survivors, whether in the emergency
department or on the battlefield immediately after trauma, to
prevent the development of ‘invisible wounds’,” said Samuel McLean,
MD, Professor at UNC, School of Medicine, and lead principal
investigator of the proposed study. Dr. McLean continued, “We need
to investigate potential treatments like ACER-801 in an effort to
better address these challenges.”
The proposed Osanetant After Stress to Increase recovery Success
(OASIS) trial will examine the safety and efficacy of ACER-801 to
reduce acute stress response symptoms, post-traumatic stress
disorder symptoms and behavioral changes among patients presenting
to the emergency department after a motor vehicle collision. It is
intended to enroll a total of 180 subjects who will be randomized
in the emergency department, to receive a low or high dose of
ACER-801 or placebo in the emergency department and be discharged
with a two-week supply of study drug. Participating sites would
include Washington University in St. Louis, University of
Massachusetts Chan Medical School, Rhode Island Hospital,
University of Florida College of Medicine – Jacksonville, and
Indiana University School of Medicine.
Initiation of patient enrollment in the proposed investigator
sponsored OASIS trial is anticipated in the first half of 2023,
subject to Investigational New Drug (IND) application filing and
U.S. Food and Drug Administration (FDA) clearance.
The OASIS trial will build upon a foundation of knowledge and
infrastructure developed through the UNC-led, $40 million AURORA
initiative. The AURORA study is a major national research
initiative to improve the understanding, prevention, and recovery
of individuals who have experienced a traumatic event. AURORA is
supported by funding from NIH, One Mind, private foundations, and
partnerships with leading tech companies such as Mindstrong Health
and Verily Life Sciences, the health care arm of Google’s parent
company Alphabet.
“We are proud to be partnering with a leading academic
institution in the field of trauma recovery as we seek to explore
ACER-801 as a treatment option to reduce the frequency and severity
of PTSD. Leveraging the support from the AURORA initiative allows
Acer and UNC to streamline trial efficiency, reduce costs and
increase trial power through enriching the target patient
population, while utilizing the Department of Defense’s
non-dilutive capital to primarily fund OASIS,” said Adrian Quartel,
MD, FFPM, Chief Medical Officer of Acer. “The data from thousands
of motor vehicle collisions collected through the AURORA initiative
should allow us to better predict the correlation of the emergence
of acute stress disorder or PTSD symptoms following a motor vehicle
collision. We look forward to the planned OASIS trial following IND
filing and FDA clearance.”
Added Brandon Staglin, President of One Mind “We are thrilled to
see how our funding to the AURORA initiative over the last five
years is accelerating further advancements such as the OASIS Trial.
The targeted outcomes of the OASIS Trial are the types of results
that One Mind supports and of incredible value to anyone who
experiences trauma and traumatic stress.”
Acute and chronic stress disorders can affect both civilian and
military populations. According to the National Center for PTSD, in
the US about 60% of men and 50% of women experience at least one
trauma in their lives.2 In the US alone, one-third of emergency
department visits (40-50 million patients per year) are for
evaluation after trauma exposures, and in a 2014 study involving
3,157 US veterans, 87% reported exposure to at least one
potentially traumatic event during their service.3 Moreover, as
many as 500,000 US troops who served in wars between 2001 and 2015
were diagnosed with PTSD.4
Rationale for ACER-801 (osanetant) Evaluation in
Post-Traumatic Stress Disorder. The Tacr3 gene
encodes tachykinin receptor 3 (NK3R), which belongs to the
tachykinin receptor family. This family of proteins includes
typical G protein-coupled receptors and belongs to the rhodopsin
subfamily. NK3R functions by binding to its high-affinity ligand,
Neurokinin B (NKB), which is encoded by the Tac3 (human) gene. The
role of NKB-NK3R in growth and reproduction has been
extensively studied, but NKB-NK3R is also widely expressed in
the nervous system from the spinal cord to the brain and is
involved in both physiological and pathological processes in the
nervous system.5 In animal models, Tac2 (mice) mRNA levels are
rapidly up-regulated during fear consolidation 30 minutes after
fear conditioning, and subsequent NKB-NK3R activation can lead to
over stress sensitization and the consolidation of fear,6 and
treatment with osanetant has been shown to block a critical
fear/stress sensitization step in the brain.7,8,9 An effective
therapeutic to reduce acute and persistent/long-term psychological
and somatic symptoms would fulfill a large unmet need.
About Acer TherapeuticsAcer is a pharmaceutical
company focused on the acquisition, development and
commercialization of therapies for serious rare and
life-threatening diseases with significant unmet medical needs.
Acer’s pipeline includes four investigational programs: ACER-001
(sodium phenylbutyrate) for treatment of various inborn errors of
metabolism, including urea cycle disorders (UCDs) and Maple Syrup
Urine Disease (MSUD); ACER-801 (osanetant) for treatment of induced
Vasomotor Symptoms (iVMS) and post-traumatic stress disorder
(PTSD); EDSIVO™ (celiprolol) for treatment of vascular
Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III
collagen (COL3A1) mutation; and ACER-2820 (emetine), a
host-directed therapy against a variety of viruses, including
cytomegalovirus, Zika, dengue, Ebola and COVID-19. For more
information, visit www.acertx.com.
References
- Sidran Institute. Traumatic Stress Education & Advocacy
Fact Sheet.
- National Center for PTSD. How Common is PTSD in Adults?
- Wisco et al. 2014 J Clin Psychiatry. Posttraumatic stress
disorder in the US veteran population: results from the National
Health and Resilience in Veterans Study. J Clin Psychiatry . 2014
Dec;75(12):1338-46
- Thompson 2015. Unlocking the secrets of PTSD. Time
2015;185:40–43
- Zhang et al. ACS Chemical Neuroscience 2020 11 (19),
2935-2943
- Al Abed et. Al, Biological Psychiatry 2021
- Andero R, Dias BG, Ressler KJ. A role for Tac2, NkB, and Nk3
receptor in normal and dysregulated fear memory consolidation.
Neuron. 2014;83(2):444-454
- Andero R, Daniel S, Guo JD, et al. Amygdala-Dependent Molecular
Mechanisms of the Tac2 Pathway in Fear Learning.
Neuropsychopharmacology. 2016;41(11):2714-2722
- Zelikowsky M, Ding K, Anderson DJ. Neuropeptidergic Control of
an Internal Brain State Produced by Prolonged Social Isolation
Stress. Cold Spring Harb Symp Quant Biol. 2018;83:97-103
Acer Forward-Looking StatementsThis press
release contains “forward-looking statements” that involve
substantial risks and uncertainties for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995.
All statements, other than statements of historical facts, included
in this press release are forward-looking statements. Examples of
such statements include, but are not limited to, statements about
the role we believe ACER-801 could play in reducing the frequency
and severity of PTSD, the planned clinical evaluation of ACER-801
for such indication, plans with respect to the OASIS trial,
including enrollment, timing and participants, and the continued
development of ACER-801 for treatment of iVMS. Our pipeline
products (including ACER-801) are under investigation and their
safety and efficacy have not been established and there is no
guarantee that any of our investigational products in development
will receive health authority approval or become commercially
available for the uses being investigated. We may not actually
achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in the forward-looking
statements and you should not place undue reliance on these
forward-looking statements. Such statements are based on
management’s current expectations and involve risks and
uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors, including, without limitation, the
availability of financing to fund our pipeline product development
programs and general corporate operations as well as risks related
to drug development and the regulatory approval process, including
the timing and requirements of regulatory actions. We disclaim any
intent or obligation to update these forward-looking statements to
reflect events or circumstances that exist after the date on which
they were made. You should review additional disclosures we make in
our filings with the Securities and Exchange Commission, including
our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
You may access these documents for no charge
at http://www.sec.gov.
Acer ContactsCorporate contact:Jim DeNikeAcer
Therapeutics Inc.jdenike@acertx.com+1-844-902-6100
Investor contact:Nick ColangeloGilmartin
Groupnick@gilmartinIR.com+1-332-895-3226
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