Tonix Pharmaceuticals to Present at Two Upcoming Investor Conferences in January: Focus is on TNX-102 SL for the Management of Fibromyalgia Following Positive Topline Results in Second Pivotal Phase 3 Trial
- Positive results from a Phase 3 trial for TNX-102 SL, with a significant reduction in daily pain over placebo (p = 0.00005)
- Plans to submit a New Drug Application to the FDA in the second half of 2024
- Updates on various development candidates across different therapeutic areas, including rare diseases, immunology, and infectious diseases
- Marketed products Zembrace SymTouch and Tosymra for the treatment of acute migraine
- None.
Insights
The recent announcement by Tonix Pharmaceuticals regarding the positive Phase 3 trial results for TNX-102 SL, a non-opioid analgesic, is a significant milestone in the pharmaceutical industry, particularly within the pain management sector. The primary endpoint's statistical significance (p = 0.00005) indicates a high level of confidence in the drug's efficacy over placebo, which could position TNX-102 SL as a potentially safer alternative to opioid medications, addressing a critical need in the market.
From a market perspective, the advancement of TNX-102 SL towards a New Drug Application (NDA) submission could have substantial implications for Tonix Pharmaceuticals' market valuation and investor interest. The drug's potential to treat fibromyalgia and its exploration for treating fibromyalgia-type Long COVID, diversifies its application, potentially broadening the target patient population and enhancing market penetration upon approval.
Furthermore, the company's diverse pipeline, including TNX-1300 with Breakthrough Therapy designation for cocaine intoxication and TNX-2900 for Prader-Willi syndrome, reflects a strategic focus on addressing unmet medical needs. This diversified approach could mitigate investment risks and provide multiple streams of potential revenue in the future. Investors will likely monitor the progress of these candidates closely, as each milestone achieved could impact the company's stock performance.
The efficacy of TNX-102 SL in reducing daily pain and its positive effects across all six key secondary endpoints is a promising development in the field of pain management. The move to submit an NDA to the FDA in the latter half of 2024 suggests that Tonix Pharmaceuticals is confident in the drug's clinical profile and its potential to meet the FDA's efficacy and safety standards.
Considering the opioid crisis, the development of non-opioid analgesics like TNX-102 SL is crucial. The drug's mechanism of action as a sublingual tablet allows for potentially quicker onset of pain relief without the risks associated with opioid use. The treatment of fibromyalgia, a condition characterized by widespread musculoskeletal pain, is challenging and current treatment options are limited. Therefore, TNX-102 SL could represent a significant advancement in patient care.
Additionally, the investigation of TNX-102 SL for fibromyalgia-type Long COVID reflects an agile response to emerging health issues. As Long COVID remains a concern, treatments addressing its symptoms, such as chronic pain, could see high demand. The dual application for both traditional fibromyalgia and Long COVID-related symptoms could provide Tonix with a competitive edge in the post-pandemic era.
The successful progression of TNX-102 SL through Phase 3 clinical trials and the planned NDA submission could have far-reaching economic implications, particularly in the context of healthcare costs associated with chronic pain management. Non-opioid analgesics like TNX-102 SL offer the potential to reduce the economic burden of opioid addiction and related healthcare costs, which have been significant in recent years.
Moreover, the potential approval and commercialization of TNX-102 SL could lead to cost savings for both patients and healthcare systems by providing an effective treatment option with potentially fewer side effects and lower risks of dependency. As healthcare systems and payers increasingly focus on value-based care, the introduction of a new non-opioid pain management solution could align well with these objectives.
It is also important to consider the economic impact of Tonix Pharmaceuticals' broader pipeline, including treatments for rare diseases and infectious diseases. The development of these treatments could lead to significant healthcare advancements and economic benefits, particularly if they address conditions with high unmet medical needs or contribute to the prevention of disease outbreaks.
TNX-102 SL is a Non-Opioid Analgesic that Demonstrated Daily Pain Reduction Over Placebo (Primary Endpoint, p = 0.00005) and Showed Positive Effects Across All Six Key Secondary Endpoints in Recently Reported Phase 3 Trial
Company Plans to Submit a New Drug Application (NDA) to the FDA in the Second Half of 2024
CHATHAM, N.J., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, will present and host investor meetings at the following January investor conferences:
| 7th Annual Neuroscience Innovation Forum by Sachs Associates | |
| Date: | Sunday, January 7, 2024 |
| Place: | Marines Memorial Club, San Francisco, Calif. |
| Time: | 3:50 p.m. PT |
| 2024 Biotech Showcase | |
| Date: | Monday, January 8, 2024 |
| Place: | Hilton San Francisco Union Square, San Francisco, Calif. |
| Room: | Yosemite C (Ballroom Level) |
| Time: | 2:00 p.m. PT |
Investors interested in arranging a meeting with the Company's management during these conferences should contact the respective conference coordinators. Replays of both webcasts of the Company’s presentations at the Neuroscience Innovation Forum and the 2024 Biotech Showcase will be available under the IR Events tab of the Tonix website at www.tonixpharma.com following each presentation.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a biopharmaceutical company focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system disorders. Tonix’s priority is to submit a New Drug Application (NDA) to the FDA for TNX-102 SL (cyclobenzaprine HCl sublingual tablet), which has completed two positive Phase 3 studies for the management of fibromyalgia. Tonix intends to meet with the FDA in the first half of 2024 and submit an NDA for the approval of TNX-102 SL for the management of fibromyalgia in the second half of 2024. TNX-102 SL is also being developed to treat fibromyalgia-type Long COVID, a chronic post-acute COVID-19 condition, and topline results from a proof-of-concept study were reported in the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2024. Tonix’s rare disease development portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome (PWS). TNX-2900 has been granted Orphan Drug designation by the FDA and an investigational new drug (IND) application has been cleared to support a Phase 2 study in PWS patients. Tonix’s immunology development portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 was initiated in the third quarter of 2023. Tonix’s infectious disease pipeline includes TNX-801, a vaccine in development to prevent smallpox and mpox. TNX-801 also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases, including TNX-1800, in development as a vaccine to protect against COVID-19. During the fourth quarter of 2023, TNX-1800 was selected by the U.S. National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) Project NextGen for inclusion in Phase 1 clinical trials. The infectious disease development portfolio also includes TNX-3900 and TNX-4000, which are classes of broad-spectrum small molecule oral antivirals. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg under a transition services agreement with Upsher-Smith Laboratories, LLC from whom the products were acquired on June 30, 2023. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults.
* Tonix’s product development candidates are investigational new drugs or biologics and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statement that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “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 such forward-looking statements. These factors include, but are not limited to, statements about the expected closing of the offering; anticipated gross proceeds from the offering; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation 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 year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2023, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182
Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505
Media Contact
Ben Shannon
ICR Westwicke
ben.shannon@westwicke.com
(919) 360-3039
FAQ
What are the key findings from Tonix Pharmaceuticals' Phase 3 trial for TNX-102 SL?
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What are the marketed products of Tonix Pharmaceuticals?
