Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the 2024 Military Health System Research Symposium (MHSRS)
Tonix Pharmaceuticals (Nasdaq: TNXP) presented data on TNX-102 SL, a potential non-opioid analgesic for fibromyalgia, at the 2024 Military Health System Research Symposium. The Phase 3 RESILIENT study showed statistically significant improvement in the primary endpoint of fibromyalgia nociplastic pain (p-value=0.00005) and all six key secondary endpoints, including sleep quality. Post hoc analyses revealed strong correlations between improvements in pain and sleep quality, supporting the concept of targeting sleep to achieve syndromal improvement in fibromyalgia.
TNX-102 SL was well-tolerated with no new safety signals. Tonix plans to submit a New Drug Application (NDA) in the second half of 2024, with an FDA decision expected in 2025. The company believes TNX-102 SL could be the first new treatment option for fibromyalgia in 15 years.
Tonix Pharmaceuticals (Nasdaq: TNXP) ha presentato dati su TNX-102 SL, un potenziale analgesico non oppioide per la fibromialgia, al Simposio di Ricerca del Sistema Sanitario Militare 2024. Lo studio di Fase 3 RESILIENT ha mostrato un risultato statisticamente significativo nel parametro principale del dolore nociplastico nella fibromialgia (p-value=0.00005) e in tutti e sei i parametri secondari chiave, inclusa la qualità del sonno. Analisi post hoc hanno rivelato forti correlazioni tra i miglioramenti nel dolore e nella qualità del sonno, supportando il concetto di mirare al sonno per ottenere un miglioramento sindromico nella fibromialgia.
TNX-102 SL è stato ben tollerato senza nuovi segnali di sicurezza. Tonix prevede di presentare una Domanda di Nuovo Farmaco (NDA) nella seconda metà del 2024, con una decisione da parte della FDA attesa nel 2025. L'azienda ritiene che TNX-102 SL potrebbe essere la prima nuova opzione di trattamento per la fibromialgia in 15 anni.
Tonix Pharmaceuticals (Nasdaq: TNXP) presentó datos sobre TNX-102 SL, un potencial analgésico no opioide para la fibromialgia, en el Simposio de Investigación del Sistema de Salud Militar 2024. El estudio de Fase 3 RESILIENT mostró una mejora estadísticamente significativa en el objetivo principal del dolor nociplástico en fibromialgia (p-valor=0.00005) y en los seis parámetros secundarios clave, incluida la calidad del sueño. Los análisis post hoc revelaron fuertes correlaciones entre las mejoras en el dolor y la calidad del sueño, respaldando el concepto de enfocar el sueño para lograr una mejora en el síndrome de fibromialgia.
TNX-102 SL fue bien tolerado sin nuevos signos de seguridad. Tonix planea presentar una Solicitud de Nuevo Medicamento (NDA) en la segunda mitad de 2024, con una decisión de la FDA esperada para 2025. La empresa cree que TNX-102 SL podría ser la primera nueva opción de tratamiento para la fibromialgia en 15 años.
톤익스 제약(Tonix Pharmaceuticals, Nasdaq: TNXP)은 2024년 군 건강 시스템 연구 심포지엄에서 섬유근육통에 대한 잠재적인 비오피오이드 진통제인 TNX-102 SL에 대한 데이터를 발표했습니다. 3상 RESILIENT 연구는 섬유근육통의 nociplastic 통증의 주요 목표에서 통계적으로 유의미한 개선(p-값=0.00005)과 수면 질을 포함한 6가지 주요 부차적 목표에서의 개선을 보여주었습니다. 사후 분석 결과 통증 개선과 수면 질 개선 간의 강한 상관관계가 나타나, 섬유근육통의 증후군 개선을 위해 수면을 목표로 하는 개념을 뒷받침했습니다.
TNX-102 SL은 새로운 안전 신호 없이 잘 tolerated되었습니다. 톤익스는 2024년 하반기에 신약 신청(NDA)을 제출할 계획이며, 2025년까지 FDA 결정이 예상됩니다. 회사는 TNX-102 SL이 15년 만에 섬유근육통에 대한 첫 번째 새로운 치료 옵션이 될 수 있다고 믿고 있습니다.
Tonix Pharmaceuticals (Nasdaq: TNXP) a présenté des données sur TNX-102 SL, un analgésique non opioïde potentiel pour la fibromyalgie, lors du Symposium de recherche du système de santé militaire 2024. L'étude de Phase 3 RESILIENT a montré une amélioration statistiquement significative du critère principal de la douleur nociplastique dans la fibromyalgie (p-value=0.00005) ainsi que dans les six critères secondaires clés, y compris la qualité du sommeil. Les analyses post hoc ont révélé de fortes corrélations entre les améliorations de la douleur et de la qualité du sommeil, soutenant le concept de cibler le sommeil pour obtenir une amélioration syndromique dans la fibromyalgie.
TNX-102 SL a été bien toléré sans nouveaux signaux de sécurité. Tonix prévoit de soumettre une demande de nouveau médicament (NDA) dans la seconde moitié de 2024, avec une décision de la FDA prévue en 2025. L'entreprise estime que TNX-102 SL pourrait être la première nouvelle option de traitement pour la fibromyalgie en 15 ans.
Tonix Pharmaceuticals (Nasdaq: TNXP) hat Daten zu TNX-102 SL präsentiert, einem potenziellen nicht-opioiden Analgetikum für Fibromyalgie, auf dem 2024 Military Health System Research Symposium. Die Phase-3-Studie RESILIENT zeigte eine statistisch signifikante Verbesserung des primären Endpunkts des nociplastischen Schmerzes bei Fibromyalgie (p-Wert=0.00005) und in allen sechs wichtigen sekundären Endpunkten, einschließlich der Schlafqualität. Post-hoc-Analysen ergaben starke Korrelationen zwischen den Verbesserungen bei Schmerz und Schlafqualität und unterstützen das Konzept, den Schlaf anzusprechen, um eine syndromale Verbesserung der Fibromyalgie zu erreichen.
TNX-102 SL wurde gut vertragen, ohne neue Sicherheitszeichen. Tonix plant, im zweiten Halbjahr 2024 einen Neuantragsantrag (NDA) einzureichen, mit einer FDA-Entscheidung, die für 2025 erwartet wird. Das Unternehmen glaubt, dass TNX-102 SL die erste neue Behandlungsoption für Fibromyalgie seit 15 Jahren sein könnte.
- TNX-102 SL met the primary endpoint of significantly reducing daily pain compared to placebo (p-value=0.00005) in the Phase 3 RESILIENT study
- Statistically significant improvement in all six pre-specified key secondary endpoints
- Strong correlations between improvements in pain and sleep quality at Week 14
- TNX-102 SL was well-tolerated with no new safety signals
- FDA granted Fast Track designation for TNX-102 SL
- NDA submission on track for second half of 2024
- Potential to be the first new treatment option for fibromyalgia in 15 years
- None.
The Phase 3 RESILIENT study results for TNX-102 SL in fibromyalgia are highly promising. The drug demonstrated statistically significant improvement in the primary endpoint of reducing daily pain (p-value=0.00005) and all six key secondary endpoints. This broad spectrum of benefits, including improved sleep quality and reduced fatigue, is particularly noteworthy.
The strong correlation between pain reduction and sleep quality improvement supports the drug's mechanism of action, targeting non-restorative sleep. This approach differentiates TNX-102 SL from traditional analgesics, which often prove ineffective for fibromyalgia. The favorable safety profile, consistent with previous studies, further enhances its potential as a treatment option.
With two positive Phase 3 studies, TNX-102 SL is well-positioned for FDA approval, potentially becoming the first new fibromyalgia treatment in 15 years. Its potential application in other chronic overlapping pain conditions (COPCs) could significantly expand its market reach.
Tonix Pharmaceuticals' progress with TNX-102 SL presents a significant opportunity for investors. The positive Phase 3 results in fibromyalgia, a condition affecting an estimated 2-4% of the U.S. population, indicate a substantial market potential. With the NDA submission planned for H2 2024 and a potential FDA decision in 2025, Tonix is approaching a critical milestone.
The Fast Track designation granted by the FDA could accelerate the approval process, potentially bringing the product to market sooner. This is important for Tonix's financial outlook, as it could lead to revenue generation in the near term. Moreover, the drug's potential applications in other COPCs like post-concussive syndrome could provide multiple revenue streams.
Investors should note that while the clinical results are promising, regulatory approval and market acceptance remain key hurdles. The company's ability to successfully commercialize TNX-102 SL will be critical for its future financial performance and stock valuation.
Oral presentation highlighted results from confirmatory Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine HCl) treatment demonstrating statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality
NDA submission on track for second half 2024; Fast Track designation granted by FDA; FDA decision expected 2025
TNX-102 SL is a potential non-opiod analgesic targeting non-restorative sleep in fibromyalgia: Post hoc analyses highlight strong correlations between improvements in nociplastic pain and sleep quality
Nociplastic pain originates from altered pain perception in the brain and is the type of pain that manifests in fibromyalgia and other chronic overlapping pain conditions (COPCs)
CHATHAM, N.J., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, presented data in an oral presentation at the 2024 Military Health System Research Symposium (MHSRS), held August 26-29, 2024, in Kissimmee, Fla. A copy of the Company’s presentation, titled “Assuaging Agony: Novel Pain Therapeutics”, is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
In the Phase 3 RESILIENT study, TNX-102 SL met the pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p-value=0.00005) in participants with fibromyalgia. TNX-102 SL demonstrated broad syndromal benefits with statistically significant improvement in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. A post hoc analysis showed strong correlations between improvements in pain and sleep quality at Week 14, supporting the concept that targeting sleep quality has the potential to achieve syndromal improvement in fibromyalgia. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed.
“Traditional analgesics like NSAIDs or opioids often prove ineffective, if not deleterious, as strategies for treating fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “In contrast, TNX-102 SL provided broad-spectrum symptom relief in the Phase 3 RESILIENT study and was designed as a bedtime treatment to target non-restorative sleep and improve sleep quality. With the statistically significant results of two positive Phase 3 studies of TNX-102 SL in fibromyalgia we believe TNX-102 SL has the potential to be the first new treatment option for fibromyalgia patients in 15 years.”
Dr. Lederman continued, “Fibromyalgia is the prototypic nociplastic syndrome and chronic overlapping pain condition (COPC)3,4,5. Our results in fibromyalgia suggest potential for TNX-102 SL in treating other COPCs like post-concussive syndrome6, in which sleep disturbances correlate with persistence and severity. In addition, we expect to begin enrolling this quarter in a trial of TNX-102 SL for acute stress disorder/acute stress reaction in the immediate aftermath of motor vehicle collision in the U.S. Department of Defense (DoD)-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial conducted by the University of North Carolina under an investigator-initiated investigational new drug (IND) application.
Tonix remains on track to submit a new drug application (NDA) to the FDA in the second half of 2024 for TNX-102 SL for the management of fibromyalgia. A decision on approval is expected in 2025.
1Moldofsky H, et al. Psychosom Med. 1975;37:341-51
2Moldofsky H, Scarisbrick P. Psychosom Med. 1976;38:35-44
3Fitzcharles MA, et al. Lancet. 2021;397:2098-110
4Clauw DJ. Ann Rheum Dis. Published Online First: 2024
5Kaplan CM, et al. Nat Rev Neurol. 2024;20, 347–363
6Kureshi S et al. Healthcare (Basel) 2024 12(3): 289.
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including anxiety and depression, headaches, and abdominal pain or cramps. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. According to the recent report from the U.S. National Academies of Sciences, fibromyalgia is a diagnosable condition that may also occur in the context of Long COVID
About TNX-102 SL
TNX-102 SL is a centrally acting, non-opioid, non-addictive, bedtime investigational drug. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed for the management of fibromyalgia. In December 2023, the company announced highly statistically significant and clinically meaningful topline results in RESILIENT, the second pivotal Phase 3 clinical trial of TNX-102 SL for the management of fibromyalgia. In the study, TNX-102 SL met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia. Statistically significant and clinically meaningful results were also seen in all six key secondary endpoints related to improving sleep quality, reducing fatigue and improving overall fibromyalgia symptoms and function. RELIEF, the first statistically significant Phase 3 trial of TNX-102 SL in fibromyalgia, was completed in December 2020. It met its pre-specified primary endpoint of daily pain reduction compared to placebo (p=0.010) and showed activity in key secondary endpoints. In both pivotal studies, the most common treatment-emergent adverse event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe, and rarely led to study discontinuation (one participant in each study). TNX-102 SL was recently granted Fast Track Designation by the FDA for the management of fibromyalgia and remains on track to submit an NDA to FDA in the second half of 2024.
About Nociplastic Pain
Nociplastic pain is the third category of pain distinct from nociceptive pain and neuropathic pain. Nociplastic pain is characterized by pain arising from altered nociception despite no evidence of actual or threatened tissue damage causing activation of peripheral nociceptors or somatosensory system disease or lesion. Its underlying pathophysiology involves altered pain processing by the central nervous system (CNS). Nociplastic syndromes, officially recognized by the International Association for the Study of Pain (IASP) in 2017, also include several other chronic overlapping pain conditions: myalgic encephalomyelitis/chronic fatigue syndrome, irritable bowel syndrome, temporomandibular disorders, forms of chronic back pain and chronic headache. The pathophysiology of nociplastic pain involves central sensitization (CS), where neurons of the CNS become hyperexcitable, amplifying pain signals. CS can be triggered by peripheral pain stimuli, emotional stress, or other factors, leading to persistent pain despite no peripheral nociceptive input.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix recently announced the U.S. DoD, Defense Threat Reduction Agency (DTRA) awarded it a contract for up to
*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.
This press release and further information about Tonix can be found 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. 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, 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, 2023, as filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024, 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.
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FAQ
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