Acer Therapeutics announced the expansion of ACER-801 | Techy Kings

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Patents and patent applications from Emory University for certain post-traumatic stress disorder (PTSD) treatment and prevention methods have been granted exclusive worldwide rights to Osanetant.

Osanetant targets specific brain cells in a region of the brain that controls the formation and consolidation of fear memories.Helps prevent PTSD1

Up to 20% of people who experience a traumatic event develop PTSD2 It leads up In one year, about 12 million adults in the US suffer from PTSD3

NEWTON, Mass., Oct. 05, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (NASDAQ: ACR ), a pharmaceutical company focused on discovering, developing and commercializing breakthrough therapies for serious, rare and life-threatening diseases. Unmet medical needs, today announced the expansion 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 a traumatic event, while PTSD is defined as the long-term effects of trauma.

Research conducted at Emory University identified thousands of genes activated in the brains of mice following fear conditioning events. The most identified gene is Tac2, which is responsible for the production of the peptide, Neurokinin B (NKB), in mice. The researchers found that the Tac2 gene, which is specifically expressed by neurons in the amygdala, is required for the formation of fear memories, and that NKB and a specific receptor, NK3R, are involved in the consolidation of fear memories. By administering a potent and specific NK3R antagonist, osanetant, they were able to strengthen fear memory shortly after exposure to a traumatic event, which may provide a new therapeutic approach to disorders such as altered fear learning such as PTSD.1

“Immediately – from hours to several days – after exposure to trauma, the memory remains in a latent state, the so-called memory consolidation period, and strengthening the fear memory reduces the frequency and severity of PTSD in trauma patients,” said Kerry Ressler. MD, PhD, Chief Scientific Officer and James and Patricia Potters in Psychiatry at McLean Hospital.

“Activating the NK3 receptor pathway in the central amygdala is necessary and sufficient for conditioning fear memories, and we have learned that by blocking this pathway with osanetant, we can strengthen fear memories in animal models.”1 Dr. Ressler added. “Osanetant is a promising agent that may reduce the frequency and severity of PTSD for millions of people who experience trauma.”

Acer previously entered into an agreement with Emory to obtain an exclusive worldwide license to US Patent No. 10,314,835, US Application 15/320,952 and European Patent No. EP3160469.

“We are pleased to expand our ACER-801 development program to PTSD, a chronic mental illness that affects millions of people each year. Today’s announcement further validates Acer’s strategy of identifying and developing promising technology based on new pathways for use. It’s about diseases that can be used in diseases,” commented Chris Schelling, CEO and founder of Acer Therapeutics. While the role of the NK3R pathway in the hypothalamus to regulate temperature has been well established in clinical trials, this possibility explores an entirely different mechanism of action for the drug. We look forward to presenting our clinical development plan for ACER-801 to reduce the frequency and severity of PTSD in the near future.

According to the National PTSD Center, about 6 in 10 men (or 60%) and 5 in 10 women (or 50%) in the US will experience at least one trauma in their lifetime, affecting approximately 12 million adults in the US. Having PTSD in one year.3 In the US alone, one-third of emergency room visits are for evaluation after a traumatic event, and up to 20% of people who experience a traumatic event develop PTSD.4

Evaluation of ACER-801 (osanetant) in post-traumatic stress disorder.
The Tacr3 gene encodes tachykinin receptor 3 (NK3R), a member of the tachykinin receptor family. This family of proteins includes the common G protein-coupled receptors and is a subfamily of rhodopsin. NK3R functions by binding to the high-affinity neurokinin B (NKB) encoded by the Tac3 (human) gene. The role of NKB-NK3R in development and reproduction has been widely studied, but NKB-NK3R is 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 (mouse) mRNA levels are rapidly upregulated after 30 minutes of fear conditioning, and NKB-NK3R activation enhances anxiety and fear conditioning.6 And treatment with osanetant has been shown to block a critical level of fear/stress perception in the brain.1,7,8 An effective treatment to reduce acute and persistent/long-term psychological and somatic symptoms fills a large unmet need.

About Acer Therapeutics
Acer is a pharmaceutical company focused on discovering, developing and commercializing therapies for severe rare and life-threatening medical needs. Acer’s pipeline includes four investigational programs: ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, 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 confirmed type III collagen (COL3A1) mutations; 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

  1. Andero R, Dias BG, Ressler KJ Roles for Tac2, NkB and Nk3 receptors in normal and conditioned fear memory consolidation. Neuron. 2014;83(2):444-454
  2. Sidran Institute. Traumatic Stress Education and Advocacy Fact Sheet.
  3. National Center for PTSD. How common is PTSD in adults?
  4. Sidran Institute. Traumatic Stress Education and Advocacy Fact Sheet.
  5. Zhang et al. Tacr3/NK3R: beyond their role in reproduction. ACS Chemical Neuroscience 2020 11 (19), 2935-2943.
  6. Al is crazy and. 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. Zelikowski M, Ding K, Anderson DJ. Neuropeptidergic regulation of endogenous brain states induced by chronic social isolation stress. Cold Spring Herb Symp. Kunt Bio. 2018;83:97-103

Acer forward-looking statements
This press release For purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995, they contain “forward-looking statements” that involve significant risks and uncertainties. All statements contained in this press release are forward-looking, except for statements of historical fact. – Similar statements. Examples of such statements include, but are not limited to, statements regarding the role of ACER-801 in reducing the frequency and severity of PTSD, the planned clinical evaluation of ACER-801, and the continued development of ACER. -801 for IVMS treatment. Our pipeline products (including ACER-801) are investigational and their safety and efficacy have not been proven, and there is no guarantee that any of our investigational products in development will receive health authority approval or be commercially available for the uses being investigated. We may not actually achieve the plans, achieve the objectives 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 may differ from those projected in forward-looking statements due to a number of factors, including, without limitation, pipeline product development programs and general corporate operations, as well as the availability of funding due to drug-related risks. Development and regulatory approval process, including timing and requirements for regulatory actions. We disclaim any intention or obligation to update these forward-looking statements to reflect events or circumstances after the date they are made. You should review our additional filings with the Securities and Exchange Commission, including our quarterly reports on Form 10-K and our quarterly reports on Form 10-Q. You can access these documents at no charge at http://www.sec.gov.

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

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

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