Oragenics, Inc. Updates Shareholders on Concussion Drug Progress and Phase II Trial Preparation
Oragenics, Inc. Updates Shareholders on Concussion Drug Progress and Phase II Trial Preparation
Oragenics, Inc. Updates Shareholders on Concussion Drug Progress and Phase II Trial Preparation
Oragenics, Inc. 向股東通報腦震盪藥物進展和二期試驗準備的最新情況
SARASOTA, Fla., Oct. 09, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a biopharmaceutical company committed to developing novel therapies for neurological disorders, today provided a corporate update reflecting on the company's progress throughout 2024, including key milestones in the development of ONP-002, its lead candidate for the treatment of concussions.
佛羅里達州薩拉索塔,2024年10月9日(環球新聞專線)——致力於開發神經系統疾病新療法的生物製藥公司Oragenics, Inc.(紐約證券交易所美國股票代碼:OGEN)今天提供了公司最新情況,反映了該公司在2024年全年取得的進展,包括其主要腦震盪治療候選藥物 ONP-002 開發的關鍵里程碑。
Company Overview: A Vision for Innovation in Neurology
Oragenics is focused on revolutionizing drug delivery for neurological disorders using innovative intranasal technology. The company's lead program, ONP-002, is a first-in-class neurosteroid being developed to treat moderate to severe concussions. Intranasal delivery provides numerous advantages over traditional systemic methods, including faster brain delivery, reduced systemic exposure, and a non-invasive approach.
公司概述:神經病學創新願景
Oragenics專注於使用創新的鼻內技術徹底改變神經系統疾病的藥物輸送。該公司的主要項目 ONP-002 是首款用於治療中度至重度腦震盪的神經類固醇。與傳統的全身方法相比,鼻內給藥具有許多優勢,包括更快的大腦輸送、減少全身暴露和非侵入性方法。
"Our mission is to address significant unmet medical needs by developing cutting-edge therapies," stated Michael Redmond, President of Oragenics. "There are over 3 million annual concussion occurrences in the U.S. and an estimated 69 million globally, however it is believed that a substantial number, up to 50%, of cases go unreported. Given that there is still no FDA approval, and patients in need continue to face limited treatment options, the urgency to advance our efforts is greater than ever.
Oragenics總裁邁克爾·雷德蒙德表示:「我們的使命是通過開發尖端療法來滿足尚未滿足的重大醫療需求。」“美國每年有超過300萬起腦震盪事件,全球估計有6900萬起腦震盪事件,但據信有相當一部分(高達50%)的病例沒有報告。鑑於仍未獲得美國食品藥品管理局的批准,而且有需要的患者仍然面臨有限的治療選擇,因此推進我們努力的緊迫性比以往任何時候都更加緊迫。
Key Milestones in Concussion Drug Development
Oragenics has made significant advancements in the development of ONP-002 during 2024, including:
腦震盪藥物研發的關鍵里程碑
2024 年,Oragenics 在 ONP-002 的開發方面取得了重大進展,包括:
Strengthened Clinical Leadership: In 2024, the company appointed two renowned experts—Dr. James "Jim" Kelly as Chief Medical Officer and Dr. William "Frank" Peacock as Chief Clinical Officer—bringing deep expertise in brain health and emergency medicine to oversee the clinical development of ONP-002.
加強臨床領導力:2024 年,公司任命了兩位知名專家——詹姆斯· 「吉姆」 · 凱利博士爲首席醫學官,威廉· 「弗蘭克」 · 孔雀博士爲首席臨床官——他們帶來了大腦健康和急診醫學方面的深厚專業知識來監督 ONP-002 的臨床開發。
Phase II Clinical Trial Preparation: Building on successful Phase I trials, which demonstrated the safety and tolerability of ONP-002, the company is preparing to initiate Phase II clinical trials, which will evaluate the drug's efficacy based on patient outcomes.
二期臨床試驗準備:在成功的 I 期試驗的基礎上,該公司正準備啓動 II 期臨床試驗,該試驗將根據患者預後評估該藥物的療效,該試驗表明 ONP-002 的安全性和耐受性。
Successful Cardiotoxicity Testing: In July 2024, ONP-002 demonstrated a strong cardiac safety margin, clearing FDA-required cardiotoxicity tests. These results suggest that the treatment is unlikely to cause cardiac arrhythmias, a crucial milestone that derisks the program as it moves forward into the Phase II clinical trial.
成功的心臟毒性測試:2024 年 7 月,ONP-002 顯示出很強的心臟安全餘地,通過了美國食品藥品管理局要求的心臟毒性測試。這些結果表明,該治療不太可能導致心律失常,這一關鍵里程碑使該項目進入二期臨床試驗時降低了風險。
FDA-Required Genotoxicity Studies: In August 2024, ONP-002 successfully completed the necessary studies regarding FDA-required genotoxicity testing, confirming that the drug does not cause DNA damage, further strengthening its safety profile as it advances towards Phase II.
美國食品藥品管理局要求的遺傳毒性研究:2024 年 8 月,ONP-002 成功完成了有關美國食品藥品管理局要求的遺傳毒性測試的必要研究,證實該藥物不會造成 DNA 損傷,進一步加強了其進入第二階段的安全性。
Partnership with Avance Clinical: In May 2024, the company entered into a partnership with Avance Clinical, a leading CRO, strengthening the company's ability to execute its Phase II trial for ONP-002 and leveraging Avance's expertise in clinical trial management and regulatory pathways.
與Avance Clinical的合作伙伴關係:2024年5月,該公司與領先的合同研究組織Avance Clinical建立了合作伙伴關係,增強了該公司執行 ONP-002 二期試驗的能力,並利用了Avance在臨床試驗管理和監管途徑方面的專業知識。
Temperature Stability Achieved: ONP-002 demonstrated stability across a wide temperature range, eliminating the need for cold-chain storage. This milestone is especially important for field delivery, where concussions frequently occur, such as in sports or military environments.
實現溫度穩定性:ONP-002 在很寬的溫度範圍內表現出穩定性,無需冷鏈存儲。這一里程碑對於野外交付尤其重要,因爲在體育或軍事環境中經常發生腦震盪。
Spray-Dry Manufacturing and Device Completion: The company completed the spray-dry formulation of ONP-002 and filled intranasal delivery devices needed for upcoming Phase II trial. These ready-to-use devices should enable fast, targeted treatment to patients following a concussion.
噴霧乾燥製造和設備完工:該公司完成了 ONP-002 的噴霧乾燥配方,並填充了即將到來的二期試驗所需的鼻內輸送設備。這些即用型設備應能爲腦震盪後的患者提供快速、有針對性的治療。
Improved Drug Percentage in Final Formulation: A novel nanoparticle spray dried powder formulation was created that should enhance intranasal absorption and increase the amount of ONP-002 per dose by 4-fold. This new formulation is expected to allow for more drug to enter the brain at each treatment increasing the chance for reaching therapeutic levels and patient improvement.
提高最終配方中的藥物百分比:開發了一種新的納米顆粒噴霧乾燥粉末配方,該配方應增強鼻內吸收,並將每劑量 ONP-002 的含量增加 4 倍。預計這種新配方將允許更多的藥物在每次治療時進入大腦,從而增加達到治療水平和患者改善的機會。
Completion of FDA-Recognized Study for Concussion Drug, ONP-002: Intranasal casting studies are critical for FDA approval of pharmaceuticals delivered via the nasal passage. The study results demonstrated the drug successfully targets the interior nose that is made from cast metal (AINI), making it more likely to reach and treat the brain after a concussion. This model is standard for intranasal drug delivery and is accepted by the FDA as a surrogate for the actual nasal.
美國食品藥品管理局認可的腦震盪藥物 ONP-002 研究的完成:鼻內鑄造研究對於美國食品藥品管理局批准通過鼻腔輸送的藥物至關重要。研究結果表明,該藥物成功地靶向由鑄造金屬(AINI)製成的鼻內部,使其更有可能在腦震盪後到達和治療大腦。該模型是鼻內藥物輸送的標準,被美國食品藥品管理局認可爲實際鼻腔的替代品。
Recent Financing and Strategic Growth
In September 2024, Oragenics closed a public offering, raising approximately $4.45 million, contributing to a total of over $6 million raised throughout the year, including previous financing efforts. These funds will support the continued development of ONP-002, allowing the company to advance toward Phase II clinical trials and further address the unmet medical need for concussion treatments.
最近的融資和戰略增長
2024年9月,Oragenics完成了公開募股,籌集了約445萬美元,全年共籌集了超過600萬美元的資金,包括之前的融資活動。這些資金將支持 ONP-002 的持續開發,使公司能夠向二期臨床試驗邁進,並進一步滿足腦震盪治療未得到滿足的醫療需求。
"We are grateful for the confidence that our investors have placed in our vision," added Redmond. "This financing allows us to continue advancing ONP-002, which we believe has the potential to be the first approved drug for concussion treatment."
雷德蒙德補充說:「我們感謝投資者對我們的願景充滿信心。」「這筆融資使我們能夠繼續推進 ONP-002,我們認爲它有可能成爲第一種獲批的腦震盪治療藥物。」
Looking Ahead: Key Milestones
Oragenics anticipates several key milestones in the coming months, including:
展望未來:關鍵里程碑
Oragenics預計未來幾個月將有幾個關鍵里程碑,包括:
Initiation of Phase II Clinical Trials: The company plans to begin Phase II trials later this year, initially in Australia, followed by U.S. trials. These trials will evaluate safety and efficacy - evaluating the effects of ONP-002 on concussion patient symptom reduction and functional recovery.
啓動二期臨床試驗:該公司計劃於今年晚些時候開始二期試驗,最初在澳大利亞進行,隨後在美國進行試驗。這些試驗將評估安全性和有效性,評估 ONP-002 對腦震盪患者症狀減輕和功能恢復的影響。
Clinical Site Selection The company is currently working with Avance Clinical, a clinical CRO along with major neurotrauma centers in Australia on Phase II clinical protocols. A key feature of the Phase II trial is to develop emergency department protocols for patient inclusion/exclusion with the goal of having the first dose occur within 8 hours of the injury. Efficacy evaluations during this 10-day trial include testing of visual-motor and neurocognitive functional performance while also assessing patient symptoms relative to drug treatment.
臨床場地選擇該公司目前正在與臨床合同研究組織Avance Clinical以及澳大利亞的主要神經創傷中心合作制定二期臨床方案。II期試驗的一個關鍵特點是制定急診科方案,將患者納入/排除在外,目標是在受傷後8小時內接種第一劑疫苗。在這項爲期10天的試驗中,療效評估包括測試視覺運動和神經認知功能表現,同時評估患者與藥物治療相關的症狀。
Australian Regulatory Submission Brochure
澳大利亞監管機構提交手冊
In preparation for its upcoming Phase II clinical trials, Oragenics plans to submit the Australian Regulatory Submission Brochure during the fourth quarter of 2024. This submission is a critical component for the regulatory approval of the trial in Australia and outlines the clinical trial safety and efficacy protocols, informed consent protocols, and data collection methods.
爲了爲即將到來的二期臨床試驗做準備,Oragenics計劃在2024年第四季度提交澳大利亞監管機構提交手冊。本文件是澳大利亞監管部門批准該試驗的關鍵組成部分,概述了臨床試驗的安全性和有效性方案、知情同意協議和數據收集方法。
Continued Development of Intranasal Delivery System: Oragenics' intranasal system is a breakthrough in brain injury drug delivery, designed to provide rapid, targeted brain delivery with minimal side effects. This system will continue to be a key focus as the company advances ONP-002. This includes the breath-propelled and automated device technologies.
鼻內給藥系統的持續發展:Oragenics的鼻內系統是腦損傷藥物輸送領域的一項突破,旨在提供快速、有針對性的大腦輸送,同時將副作用降至最低。隨着公司推進 ONP-002,該系統將繼續成爲重點。這包括呼吸推進和自動化設備技術。
Commitment to Shareholders
Oragenics remains committed to maintaining transparency and open communication with its shareholders. The company will continue to provide updates on its progress as it advances toward key milestones and works to commercialize ONP-002.
對股東的承諾
Oragenics仍然致力於保持透明度並與股東進行公開溝通。在邁向關鍵里程碑並努力將 ONP-002 商業化的過程中,該公司將繼續提供最新進展情況。
Forward-Looking Statements
前瞻性陳述
This communication contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, those described in our Form 10-K and other filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, circumstances should change, except as otherwise required by law.
本通信包含《1995年美國私人證券訴訟改革法》安全港條款所指的 「前瞻性陳述」。這些前瞻性陳述基於管理層的信念、假設和當前可用的信息。「相信」、「期望」、「預測」、「打算」、「估計」、「項目」 等詞以及不只與歷史問題相關的類似表述可識別前瞻性陳述。投資者在依賴前瞻性陳述時應謹慎行事,因爲前瞻性陳述受到各種風險、不確定性和其他因素的影響,這些因素可能導致實際業績與任何此類前瞻性陳述中表達的業績存在重大差異。這些因素包括但不限於我們在10-k表格和向美國證券交易委員會提交的其他文件中描述的因素。本新聞稿中列出的所有信息均截至本新聞稿發佈之日。在評估本新聞稿中包含的前瞻性陳述時,您應考慮這些因素,不要過分依賴此類陳述。除非法律另有規定,否則我們不承擔任何義務公開提供對任何前瞻性陳述的修訂或更新,無論是由於新信息、未來發展還是其他原因,情況都應該發生變化。
Investor Relations:
Rich Cockrell
404.736.3838
achv@cg.capital
投資者關係:
裏奇·科克雷爾
404.736.3838
achv@cg.capital
Released October 9, 2024
2024 年 10 月 9 日發佈
譯文內容由第三人軟體翻譯。