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Tonix Pharmaceuticals to Deliver an Oral Presentation and Present Two Posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Tonix Pharmaceuticals to Deliver an Oral Presentation and Present Two Posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Tonix Pharmaceuticals將在美國臨床心理藥理學會(ASCP)年會上發表口頭演講並展示兩張海報
Tonix Pharmaceuticals ·  05/22 12:00

Tonix Pharmaceuticals to Deliver an Oral Presentation and Present Two Posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Tonix Pharmaceuticals將在美國臨床心理藥理學會(ASCP)年會上發表口頭演講並展示兩張海報

May 22, 2024 8:00am EDT Download as PDF

美國東部時間 2024 年 5 月 22 日上午 8:00 以 PDF 格式下載

Oral Presentation of Tonmya (TNX-102 SL) for Fibromyalgia; NDA preparation in progress

口服治療纖維肌痛的 Tonmya (TNX-102 SL);NDA 準備工作正在進行中

Posters Highlighting Other TNX-102 SL Programs In Clinical Development; Long COVID and Acute Stress Disorder

重點介紹臨床開發中的其他 TNX-102 SL 項目的海報;長期COVID和急性應激障礙

CHATHAM, N.J., May 22, 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, today announced that the Company will deliver an oral presentation and present two posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 28-31, 2024 at the Loews Miami Beach Hotel in Miami Beach, Fla.

新澤西州查塔姆,2024年5月22日(GLOBE NEWSWIRE)——Tonix Pharmicals Holding Corp.(納斯達克股票代碼:TNXP)(Tonix或公司)是一家擁有上市產品和一系列候選開發產品的完全整合的生物製藥公司,今天宣佈,該公司將在5月28日至31日舉行的美國臨床心理藥理學會(ASCP)年會上發表口頭演講並展示兩張海報,2024 年在佛羅里達州邁阿密海灘的洛斯邁阿密海灘酒店舉行。

The oral presentation will detail findings of studies of Tonmya (TNX-102 SL, sublingual cyclobenzaprine HCl) in fibromyalgia. One poster will describe the Phase 2 proof of concept study of TNX-102 SL in fibromyalgia-type Long COVID. The second poster will describe the upcoming investigator-initiated Phase 2 trial of TNX-102 SL in treating acute stress disorder and preventing posttraumatic stress disorder after motor vehicle collision, which will be conducted by the University of North Carolina, the sponsor of the study.

口頭陳述將詳細介紹Tonmya(TNX-102 SL,舌下鹽酸環苯扎林)治療纖維肌痛的研究結果。一張海報將描述 TNX-102 SL 在纖維肌痛型長冠狀病毒中的第二階段概念驗證研究。第二張海報將描述研究人員發起的 TNX-102 SL 治療急性應激障礙和預防機動車碰撞後創傷後應激障礙的 2 期試驗,該試驗將由該研究的發起方北卡羅來納大學進行。

TNX-102 SL is a centrally acting, non-opioid medication, which is trade named Tonmya for the management of fibromyalgia. As previously announced, the second statistically significant Phase 3 study of Tonmya, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo in participants with fibromyalgia (p=0.00005). Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.

TNX-102 SL 是一種中樞作用的非阿片類藥物,其商品名爲 Tonmya,用於治療纖維肌痛。正如先前宣佈的那樣,Tonmya的第二項具有統計意義的3期研究,即RESILIENT,達到了其預先規定的主要終點,與安慰劑相比,纖維肌痛參與者的日常疼痛顯著減輕(p=0.00005)。在與改善睡眠質量、減輕疲勞以及改善整體纖維肌痛症狀和功能有關的所有關鍵次要終點中也出現了具有統計意義且具有臨床意義的結果(p=0.001 或更好)。

Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024 for Tonmya for the management of fibromyalgia and has scheduled a Type B pre-NDA meeting with FDA for the second quarter of 2024.

Tonix計劃在2024年下半年向美國食品藥品監督管理局(FDA)提交Tonmya治療纖維肌痛的新藥申請(NDA),並計劃在2024年第二季度與美國食品藥品監督管理局(FDA)舉行B型保密協議前會議。

Copies of the Company's presentation and posters will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference. Additional meeting information can be found on the ASCP website here.

公司演示文稿和海報的副本將在 科學演講 Tonix 網站的選項卡位於 www.tonixpharma.com 會議之後。其他會議信息可以在 ASCP 網站上找到 這裏

Oral Presentation Details

口頭陳述詳情

Presenter: Seth Lederman, M.D., Chief Executive Officer
Title: Effects of Bedtime TNX-102 SL (Sublingual Cyclobenzaprine (CBP) HCl) on Mood and Anxiety Symptoms in Fibromyalgia: Results of the Phase 3 RESILIENT Trial
Date/Time: May 29, 2024, 3:00 p.m. ET
演示者: 塞思·萊德曼,醫學博士,首席執行官
標題: 就寢時間 TNX-102 SL(鹽酸舌下環苯扎林(CBP))對纖維肌痛情緒和焦慮症狀的影響:3期彈性試驗結果
日期/時間: 美國東部時間 2024 年 5 月 29 日下午 3:00

Poster Presentation Details

海報展示詳情

Presenter: Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine
Title: Effect of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) on Pain, Sleep, Fatigue and Cognition in Fibromyalgia-Type Long COVID: Results of a Double-Blind Randomized Proof-of-Concept Phase 2 Study
Date/Time: May 30, 2024, 12:30 p.m. ET
Presenter: David Hsu, Ph.D., Senior Scientist
Title: Optimizing Acute Stress Reaction (ASR) Interventions with TNX-102 SL (Sublingual Cyclobenzaprine HCl) – The OASIS Trial: Sustaining Civilian Performance Post-Trauma by Reduction of ASR and Prevention of ASD/PTSD
Date/Time: May 30, 2024, 12:30 p.m. ET
演示者: 赫伯特·哈里斯,醫學博士,轉化醫學執行副總裁
標題: 睡前舌下環苯扎林 (TNX-102 SL) 對纖維肌痛型長期 COVID 患者疼痛、睡眠、疲勞和認知的影響:一項雙盲隨機概念驗證第 2 期研究的結果
日期/時間: 美國東部時間 2024 年 5 月 30 日下午 12:30
演示者: David Hsu,博士,高級科學家
標題: 使用 TNX-102 SL(舌下鹽酸環苯扎林)優化急性應激反應 (ASR) 干預措施 — OASIS 試驗:通過降低 ASR 和預防 ASD/PTSD 來維持創傷後的民事表現
日期/時間: 美國東部時間 2024 年 5 月 30 日下午 12:30

Tonix Pharmaceuticals Holding Corp.*

託尼克斯製藥控股公司*

Tonix is a fully-integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix's development portfolio is focused on central nervous system (CNS) disorders. Tonix's priority is to submit a New Drug Application (NDA) to the FDA in the second half of 2024 for Tonmya1, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID. Tonix's CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation. Tonix's immunology development portfolio consists of 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. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, our commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

Tonix是一家完全整合的生物製藥公司,專注於開發、許可和商業化治療和預防人類疾病並減輕痛苦的療法。Tonix的開發產品組合側重於中樞神經系統(CNS)疾病。Tonix的首要任務是在2024年下半年向美國食品藥品管理局提交Tonmya的新藥申請(NDA)1,該候選產品已經完成了兩項具有統計學意義的纖維肌痛管理的3期研究。TNX-102 SL也在開發中,用於治療急性應激反應以及纖維肌痛型的長冠狀病毒。Tonix 的中樞神經系統產品組合包括 TNX-1300(可卡因酯酶),這是一種旨在治療可卡因中毒的生物製劑,被指定爲突破性療法。Tonix 的免疫學開發產品組合包括用於解決器官移植排斥反應、自身免疫和癌症的生物製劑,包括 TNX-1500,這是一種靶向 CD40 配體(CD40L 或 CD154)的人源化單克隆抗體,正在開發用於預防同種異體移植排斥反應和治療自身免疫性疾病。Tonix還在罕見病和傳染病領域開發候選產品。我們的商業子公司 Tonix Medicines 銷售 Zembrace SymTou (舒馬曲坦注射液)3 mg 和 Tosymra (舒馬曲坦鼻腔噴霧劑)10 mg,用於治療成人有或沒有先兆的急性偏頭痛。

*Tonix's product development candidates are investigational new drugs or biologics and have not been approved for any indication.

*Tonix 的候選產品開發是研究性新藥或生物製劑,尚未獲得任何適應症的批准。

1Tonmya is conditionally accepted by the U.S. Food and Drug Administration (FDA) as the tradename for TNX-102 SL for the management of fibromyalgia. Tonmya has not been approved for any indication.

1美國食品藥品監督管理局(FDA)有條件地接受 Tonmya 作爲 TNX-102 SL 的商品名,用於治療纖維肌痛。Tonmya尚未獲得任何適應症的批准。

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.

Zembrace SymTouch 和 Tosymra 是 Tonix Medicines 的註冊商標。所有其他商標均爲其各自所有者的財產。

This press release and further information about Tonix can be found at www.tonixpharma.com.

本新聞稿和有關 Tonix 的更多信息可在以下網址找到 www.tonixpharma.com

Forward Looking Statements

前瞻性陳述

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.

根據1995年《私人證券訴訟改革法》,本新聞稿中的某些陳述是前瞻性的。這些陳述可以通過使用前瞻性詞語來識別,例如 “預期”、“相信”、“預測”、“估計”、“預期” 和 “打算” 等。這些前瞻性陳述基於Tonix當前的預期,實際業績可能存在重大差異。有許多因素可能導致實際事件與此類前瞻性陳述所示事件存在重大差異。這些因素包括但不限於與未能獲得美國食品藥品管理局許可或批准以及不遵守美國食品藥品管理局法規相關的風險;與未能成功銷售我們的任何產品相關的風險;與候選產品臨床開發的時間和進展相關的風險;我們對額外融資的需求;專利保護和訴訟的不確定性;政府或第三方付款人補償的不確定性;研發工作有限以及對第三方的嚴重依賴;以及大量的依賴競爭。與任何正在開發的藥物一樣,新產品的開發、監管批准和商業化也存在重大風險。Tonix沒有義務更新或修改任何前瞻性陳述。投資者應閱讀2024年4月1日向美國證券交易委員會(“SEC”)提交的截至2023年12月31日年度的10-K表年度報告以及該報告當天或之後向美國證券交易委員會提交的定期報告中列出的風險因素。Tonix的所有前瞻性陳述均受所有這些風險因素和其他警示性陳述的明確限制。此處提供的信息僅反映截至發佈之日的信息。

Investor Contact

投資者聯繫人

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

傑西卡莫里
託尼克斯製藥
investor.relations@tonixpharma.com
(862) 904-8182

Peter Vozzo
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

彼得·沃佐
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Media Contact

媒體聯繫人

Katie Dodge
LaVoieHealthScience
kdodge@lavoiehealthscience.com
(978) 360-3151

凱蒂道奇
Lavoie 健康科學
kdodge@lavoiehealthscience.com(978) 360-3151


Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.
來源:Tonix 製藥控股公司

Released May 22, 2024

2024 年 5 月 22 日發佈

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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