Acer Therapeutics Announces Expansion of ACER-801 | Media Pyro

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Exclusive worldwide rights licensed from Emory University to patents and patent applications for certain methods of treating or preventing post-traumatic stress disorder (PTSD) with oxaetant

Osanetant targets a specific group of brain cells in a region of the brain that controls the formation and consolidation of fear memorieswhich may help prevent PTSD1

Up to 20% of people who experience a traumatic event will develop PTSD2 leading to over 12 million adults in the US suffer from PTSD in a given year3

NEWTON, Mass., Oct. 05, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the discovery, 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) to a new indication, to reduce the incidence 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 examined thousands of genes that were activated in the brains of mice after 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 the modulation of 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 trauma, potentially providing a new therapeutic approach to disorders with altered fear learning such as PTSD.1

“Immediately – sometimes to a few days – after trauma exposure, the memory remains in a labile state, known as the memory consolidation period, and fear memory consolidation after trauma exposure may hinder the frequency and severity of PTSD in trauma patients reduce,” 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 to modulate fear memories, and we have learned that we can block the consolidation of fear memories in animal models by blocking this pathway with hosanetant,”1 added Dr. Ressler. “Osanetant is a promising agent that may reduce the incidence and severity of PTSD for millions of people who experience a traumatic event.”

Acer previously entered into an agreement with Emory for an exclusive worldwide license to US Patent No. 10,314,835, US Application 15/320,952, and European Patent No. EP3160469 which will cover certain methods of treating or preventing PTSD with oxalate.

“We are pleased to further expand our ACER-801 development program into PTSD, an increasingly prevalent psychiatric disorder that affects millions each year. Today’s announcement further validates Acer’s strategy to identify and develop treatments based on promising technology that can be applied in new ways for use in high-need diseases,” said Chris Schelling, CEO and Founder of Acer Therapeutics. “While the role of the NK3R pathway in the hypothalamus in managing thermoregulation is well established in clinical trials, this opportunity examines a completely different mechanism of action for the drug. We look forward to presenting our clinical development plan for ACER-801 to reduce the incidence and severity of PTSD in the near future.”

According to the National PTSD Center, in the United States about 6 out of 10 men (or 60%) and 5 out of 10 women (or 50%) have experienced at least one trauma in their lives resulting in about 12 million adults in the US. Having PTSD during a given year.3 In the United States alone, one-third of emergency department visits are for evaluation after trauma exposure and up to 20% of people who experience a traumatic event will develop PTSD.4

Rationale for Evaluation of ACER-801 (osanetant) in Post-Traumatic Stress Disorder.
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), encoded by the Tac3 gene (human). The role of NKB-NK3R in growth and reproduction has been widely studied, but NKB-NK3R is also widely expressed in the nervous system from the spinal cord to the brain and is involved in physiological and pathological processes in the nervous system.5 In animal models, Tac2 mRNA levels (mice) are rapidly upregulated during fear conditioning 30 min after fear conditioning, and subsequent NKB-NK3R activation can lead to stress hypersensitivity and fear conditioning,6 and the critical phase of fear/stress sensitization in the brain has been shown to be inhibited when treated with osmocontrast.1,7,8 An effective therapist to reduce acute and persistent/long-term psychological and somatic symptoms would fulfill a major unmet need.

About Acer Therapeutics
Acer is a pharmaceutical company focused on the discovery, 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 the treatment of various metabolic errors in the fetus, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS) and post-traumatic stress disorder (PTSD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed collagen type III (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against various viruses, including cytomegalovirus, Zika, dengue, Ebola and COVID-19. For more information, visit www.acertx.com.

References

  1. Andero R, Dias BG, Ressler KJ. A role for Tac2, NkB, and Nk3 receptors in normal and dysregulated fear memory consolidation. Neurons. 2014; 83(2):444-454
  2. Sidran Institute. Traumatic Stress Education & Advocacy Fact Sheet.
  3. National PTSD Center. How Common is PTSD in Adults?
  4. Sidran Institute. Traumatic Stress Education & Advocacy Fact Sheet.
  5. Zhang et al. Tacr3/NK3R: Beyond Its Role in Reproduction. ACS Chemical Neuroscience, 2020 11 (19), 2935-2943
  6. Al Abed et al. Al, Biological Psychiatry 2021
  7. 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
  8. Zelikowsky M, Ding K, Anderson DJ. Neuropeptidergic Regulation of Internal Brain State Produced by Prolonged Social Isolation Stress. Cold Spring Harb Symp Biol Quant Biol. 2018; 83:97-103

Acer Forward Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for the purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included in this press release on face. -seek statements. Examples of such statements include, but are not limited to, statements about the role we believe ACER-801 may play in reducing the incidence and severity of PTSD, the proposed clinical evaluation of ACER-801 for an indication of such, and the ongoing development of ACER. -801 for iVMS treatment. Our pipeline products (including ACER-801) are investigational 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 be available commercial for the uses under investigation. We may not achieve the plans, fulfill the intentions or meet the expectations or projections expressed 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. funding as well as drug related risks. development and the regulatory approval process, including the timing and requirements of regulatory actions. We disclaim any intention or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date they are 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 our Quarterly Reports on Form 10-Q. You can access these documents free of charge at http://www.sec.gov.

Acer contacts
Corporate contact:
Jim Denike
Acer Therapeutics Inc.
jdenike@acertx.com
+1-844-902-6100

Investor contact:
Nick Colangelo
The Gilmartin Group
nick@gilmartinIR.com
+1-332-895-3226

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