Tonix Pharmaceuticals presents data from a retrospective observational database study of the incidence of multi-site pain symptoms in patients with long-term COVID at the IASP World Pain Congress 2022

Tonix Pharmaceuticals Holding Corp.

About 40% of patients with long-term COVID experience multisite pain similar to overlapping chronic pain syndromes fibromyalgia and ME/CFS

About 50% of long-term COVID patients with multi-site pain and sleep disturbances use opioids

CHATHAM, N.J., Sept. 22, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced data from a retrospective, observational database study in patients diagnosed with long COVID at the World Congress on International Association for the Study of Pain (IASP) Pain 2022, to be held September 20-23, 2022 in Toronto, Canada. The study was motivated to identify the frequency of symptoms of multi-site pain, fatigue and insomnia in long COVID patients because these are the hallmarks of chronic overlapping pain syndromes like fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). A copy of the poster is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

The poster presentation titled “Retrospective study of an observational database of patients with long COVID with pain, fatigue and insomnia at multiple sites: a real-world analysis of symptomatology and opioid use“, include data from the study showing that:

  • About 40% of patients with symptoms of Long COVID had fibromyalgia-like multisite pain.

  • The rate of opioid use among long COVID patients with multi-site pain was 34% compared to 19% of long COVID patients without multi-site pain.

  • In patients with multi-site pain, opioid use increased to approximately 50% of patients when sleep disturbances were also present.

“The recently released US HHS Long COVID National Research Action Plan1 repeatedly addresses the overlap of Long COVID with ME/CFS, which, like fibromyalgia, is one of the overlapping chronic pain syndromes with central sensitization,” said Seth Lederman, MD, CEO of Tonix Pharmaceuticals . “Previously, central sensitization had been observed in approximately two-thirds of patients with Long COVID2. Data from the new retrospective study revealed that US Long COVID patients are turning to opioids for symptomatic relief, revealing the urgency of providing effective, non-opioid, non-addictive analgesics that treat multisite pain. Currently, there are no therapies approved by the United States Food and Drug Administration for the treatment of multisite pain associated with long COVID.

In August 2022, the Company announced that the first participant was enrolled in the Phase 2 PREVAIL study of TNX-102 SL as a potential treatment for patients with Long COVID Syndrome (Long COVID) whose symptoms overlap with fibromyalgia. . Long COVID is officially known as post-acute sequelae of COVID-19 (PASC).

Dr. Lederman added, “TNX-102 SL is a centrally acting, non-opioid analgesic with no known abuse potential that has been shown to decrease daily pain in a phase 3 study in fibromyalgia. The finding that approximately 40% of patients with Long COVID have fibromyalgia-like multi-site pain symptoms in the retrospective observational database study suggests that we should be able to recruit a strong cohort of participants to test the effects of TNX-102 SL in treating multi-site pain in Long COVID in our ongoing Phase 2 study.

Quotes

1US Department of Health and Human Services, August 9, 2022. “National Research Action Plan on Long COVID.” www.covid.gov/assets/files/National-Research-Action-Plan-on-Long-COVID-08012022.pdf.

2Goudman, L, et al. J from Clin Med. 2021;10(23):5594. https://doi.org/10.3390/jcm10235594

Tonix Pharmaceuticals Holding Corp.*

Tonix is ​​a clinical-stage biopharmaceutical company focused on the discovery, licensing, acquisition and development of therapies to treat and prevent human disease and alleviate suffering. Tonix’s portfolio consists of product candidates for the central nervous system (CNS), rare diseases, immunology and infectious diseases. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurological, psychiatric and addiction disorders. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study initiated in Q2 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also under development to treat long COVID, a post-acute chronic disease of COVID-19. Tonix initiated a Phase 2 study in Long COVID in Q3 2022 and expects interim data in H1 2023. FDA. A phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal boosted oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a phase 2 study in the fourth quarter of 2022. Tonix’s rare disease portfolio includes TNX-2900 (intranasal boosted oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has received orphan drug designation from the FDA. Tonix’s immunology portfolio includes biologics to treat organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting the CD40 ligand (CD40L or CD154 ) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine under development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19 and a platform to manufacture fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine under development to prevent smallpox and monkeypox, also serves as a live virus vaccine platform or a recombinant smallpox vaccine (RPV) platform for other diseases infectious. A phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate against COVID-19 is TNX-1850, a live virus vaccine based on the vaccine platform live recombinant smallpox virus from Tonix. A phase 1 study of the COVID-19 vaccine is expected to be launched in the second half of 2023.

*All At Tonix the product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix are available at www.tonixpharma.com.

Forward-looking statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements can be identified by the use of forward-looking terms such as “anticipate”, “believe”, “expect”, ” estimate”, “expect”, and “intend”, among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by these forward-looking statements. These factors include, but are not limited to, risks related to the inability to obtain FDA clearances or approvals and non-compliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks relating to the timing and progress of clinical development of our product candidates; our need for additional funding; uncertainties of patent protection and litigation; uncertainties of reimbursement by the government or third-party payer; limited research and development efforts and reliance on third parties; and significant competition. As with any pharmaceutical product under development, the development, regulatory approval and commercialization of new products involve significant risks. Tonix does not undertake to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC as of the date hereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other caveats. The information presented here is only valid as of the date thereof.

contacts

Jessica Morris (company)
Tonix Pharmaceuticals
Investor.relations@tonixpharma.com
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russian partners
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ICR Westwicke
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