Acer Therapeutics Announces Expansion of ACER-801 (osanetant) Development Indications to Include Post-Traumatic Stress Disorder
05 October 2022 - 11:30PM
Acer Therapeutics Inc. (Nasdaq: ACER), a 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 the expansion of
ACER-801 (osanetant) into a new indication, for the reduction of
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 defined
as the long-term effects of trauma.
Studies conducted at Emory University screened thousands of
genes that were activated in the brains of mice following fear
conditioning events. The top gene identified was Tac2, which is
responsible for the production of the peptide, Neurokinin B (NKB),
in mice. The researchers showed that the Tac2 gene,
expressed by neurons specifically within the amygdala, is required
for modulating fear memories, and that NKB, and its specific
receptor, NK3R, are also involved in the consolidation of fear
memories. By administering the potent and specific NK3R antagonist,
osanetant, they were able to block fear memory consolidation
shortly after exposure to a trauma, potentially providing a novel
therapeutic approach for disorders with altered fear learning such
as PTSD.1
“Immediately – hours to several days – after trauma exposure,
memory remains in a labile state, called the memory consolidation
period, and blocking fear memory consolidation after trauma
exposure could lower the frequency and severity of PTSD in trauma
patients,” said Kerry Ressler, MD, PhD, Chief Scientific Officer
and James and Patricia Poitras Chair in Psychiatry at McLean
Hospital.
“Activation of the NK3 receptor pathway in the central amygdala
is necessary and sufficient for the modulation of fear memories,
and we have learned that by blocking this pathway with osanetant,
we can block the consolidation of fear memories in animal models,”1
added Dr. Ressler. “Osanetant is a promising agent that could
reduce the frequency and of severity of PTSD for millions of people
who experience a traumatic event.”
Acer previously entered into an agreement with Emory for an
exclusive world-wide license to US Patent No. 10,314,835, US
Application 15/320,952, and European Patent No. EP3160469 covering
certain methods of treating or preventing PTSD with
osanetant.
“We are pleased to further expand our ACER-801 development
program into PTSD, an increasingly prevalent psychiatric disorder
that affects millions every year. Today’s announcement further
validates Acer’s strategy of identifying and developing treatments
based on promising technology that can be applied in new ways for
use in diseases with high unmet need,” commented Chris Schelling,
CEO and Founder of Acer Therapeutics. “While the role of the NK3R
pathway in the hypothalamus to manage thermoregulation is
well-established in clinical trials, this opportunity explores an
entirely different mechanism of action for the drug. We look
forward to presenting our clinical development plan for ACER-801
for the reduction of frequency and severity of PTSD in the near
future.”
According to the National Center for PTSD, in the US about 6 of
every 10 men (or 60%) and 5 of every 10 women (or 50%) experience
at least one trauma in their lives leading to about 12 million
adults in the U.S. have PTSD during a given year.3 In the US alone,
one-third of emergency department visits are for evaluation after
trauma exposures and up to 20% of people who have experienced a
traumatic event will develop 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.1,7,8 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
- 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
- Sidran Institute. Traumatic Stress Education & Advocacy
Fact Sheet.
- National Center for PTSD. How Common is PTSD in Adults?
- Sidran Institute. Traumatic Stress Education & Advocacy
Fact Sheet.
- Zhang et al. Tacr3/NK3R: Beyond Their Roles in Reproduction.
ACS Chemical Neuroscience 2020 11 (19), 2935-2943
- Al Abed et. Al, Biological Psychiatry 2021
- 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, 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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