Oragenics Inc. Completes Spray Dry Drug Manufacturing and Intranasal Device Filling in Anticipation of Phase IIa Clinical Trial in Concussed Patients
Oragenics Inc. Completes Spray Dry Drug Manufacturing and Intranasal Device Filling in Anticipation of Phase IIa Clinical Trial in Concussed Patients
Oragenics Inc. Completes Spray Dry Drug Manufacturing and Intranasal Device Filling in Anticipation of Phase IIa Clinical Trial in Concussed Patients
Oragenics 公司完成了噴霧乾燥藥物製造和鼻內裝置充填,爲期待的Ⅱa期腦震盪患者臨床試驗做好準備
• Falls and car accidents lead incidence of concussions in emergency departments
•緊急科的腦震盪發病率高於摔倒和車禍
• Spray-dried drug formulation allows for easy delivery to patients
•噴霧乾燥的藥物製劑方便給患者使用
• No pharmaceutical treatment is available for concussion; drug, ONP-002, could be first of its kind to treat concussion
•腦震盪沒有藥物治療方法,藥物ONP-002可能成爲首個治療腦震盪的藥物
SARASOTA, Fla., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) ("the Company"), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced the completion of its spray-dried formulation and filling in the nasal device for its lead candidate, ONP-002, for concussion. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity. The prefilled formulation is intended to provide the needed drug-device dosing for the planned Phase IIa clinical trial in concussed patients.
美國,佛羅里達州薩拉索塔,2024年8月21日(環球新聞通信) -- oragenics, inc. (NYSE紐交所美國: OGEN) ("公司"),一家專注於開發治療神經系統疾病的獨特鼻腔製藥品的公司,今天宣佈其擬議的主力藥物ONP-002針對腦震盪的噴霧乾燥配方和填充鼻部設備的完成。 ONP-002是一種新的化學實體(NCE),旨在通過輸送到鼻腔來靶向腦部。預填充配方旨在爲計劃中的腦震盪患者第二階段臨床試驗提供所需的藥物-設備劑量。
For the trial, the Company produced both placebo and ONP-002 drug for use in the Phase IIa clinical trial to be conducted in Australia. The work included the production of ONP-002 as a spray-dried nanoparticle formulation, loading of the powder in Oragenics' novel breath-propelled intranasal device, and initiating a stability program of both the drug formula alone and within the device. The Phase IIa clinical trial is expected to enroll 40 concussed patients who will receive 1:1 either placebo or the ONP-002 drug, with doses given twice a day for five consecutive days following injury. The trial aims to start treatment within 8 hours of the injury in the emergency department. It is anticipated that patient-reported outcomes and blood biomarkers will be included in the evaluation.
爲了試驗,該公司在澳大利亞進行的第二階段臨床試驗證實了安慰劑和ONP-002藥物的使用。該工作包括將ONP-002製成噴霧乾粉納米顆粒配方,將粉末裝入oragenics的新型呼吸驅動鼻腔裝置中,並啓動包括藥物配方和裝置內的穩定性方案。預計第二階段臨床試驗將招募40名腦震盪患者,他們將接受1:1安慰劑或ONP-002藥物的治療,每天兩次,持續五天。試驗旨在在急診科8小時內開始治療。預計評估將包括患者報告的結果和血液生物標誌物。
"In preparing for the Phase IIa study, we wanted to ensure that ONP-002 could be formulated as a nanoparticle and delivered intranasally as a powder to improve brain exposure. The anti-inflammatory effects of our novel neurosteroid are designed to reduce negative outcomes after a concussion. We believe the combination of the spray-dried powder in our device is ideal for field delivery, increasing the chances of stopping the neuropathology of a concussive injury early," commented Michael Redmond, President for Oragenics.
"爲了準備第IIa期研究,我們希望確保ONP-002可以製成納米顆粒並經鼻部給藥器輸送作爲粉末,以提高對腦部的暴露。我們創新的神經類固醇的抗炎作用旨在減少腦震盪後的負面結果。我們認爲我們的設備中的噴霧乾粉是實地輸送的理想選擇,增加了早期防止腦震盪損傷的神經病理學機會," oragenics總裁邁克爾·雷德蒙德評論道。
About Concussion
關於腦震盪
Concussion is an unmet medical need. There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders, including Alzheimer's Disease, Parkinson's Disease, and Chronic Traumatic Encephalopathy (CTE), have been linked to concussion. Post-concussion symptomology is linked to long-term disability and occurs in as high as 20% of concussed patients.
腦震盪是一種未滿足的醫療需求。全球每年約有6900萬例腦震盪報告。腦震盪的常見原因包括跌倒、機動車事故和接觸性運動。其他神經系統疾病,包括阿爾茨海默病、帕金森病和慢性創傷性腦病(CTE)與腦震盪有關。後腦震盪症狀與長期殘疾有關,且在腦震盪患者中發生率可高達20%。
About Oragenics
關於Oragenics
Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in fighting infectious diseases and neurological conditions, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit .
Oragenics是一家專注於鼻腔給藥的藥品公司,致力於抗擊傳染病和神經系統疾病,包括治療輕度創傷性腦損傷(mTBI,也被稱爲腦震盪)和治療尼曼匹克病C型(NPC)的藥物候選物,以及專有的粉劑製劑和鼻腔給藥設備。有關更多信息,請訪問。
Forward-Looking Statements
前瞻性聲明
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, including without limitation statements regarding the ability of the Company to timely and successfully undertake Phase II clinical trial using its novel drug-device combination for the treatment of mild Traumatic Brain Injury. 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: the Company's ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company's ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company's ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company's expectations as to the outcome of preclinical studies and clinical trials and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included 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, should circumstances change, except as otherwise required by law.
本通訊包含《美國私人證券訴訟改革法》中的適用的「前瞻性聲明」,包括但不限於有關公司能夠及時併成功進行Phase II臨床試驗使用其新藥物-器械組合治療輕度創傷性腦損傷的能力的聲明。這些前瞻性聲明基於管理層的信念、假設和當前可用信息。不僅與歷史事實有關的「相信」、「預期」、「預測」、「打算」、「估計」、「計劃」和類似表述詞,識別前瞻性聲明,投資者應在依靠前瞻性聲明時保持謹慎,因爲它們受到各種風險、不確定性和其他因素的影響,這些因素可能導致實際結果與任何此類前瞻性聲明中表達的結果在很大程度上不同。這些因素包括但不限於:公司能否在其所預計的時間表下並按照其所預期的里程碑推進其產品候選品,包括神經科學資產的發展;公司能否籌集資本並獲得用於開發其產品候選品的融資,無論是否爲非稀釋性;與其產品候選品有關的監管申請過程、研發階段和未來臨床數據和分析,包括任何會議、決策、如美國食品和藥物管理局和調查評審委員會之類的監管當局是否有利或不利;公司能否獲得、維護和執行必需的專利和其他知識產權保護;與腦震盪治療有關的競爭和發展;公司對臨床前和臨床試驗以及其產品候選品的其他經濟和市場條件和風險的預期以及其活動、效力和安全性;以及一般經濟和市場狀況和風險,以及其他在我們向美國證券交易委員會提交的文件中描述的不確定性。除非另有說明,這裏的所有信息均截至本日期。您應在評估所包含的前瞻性聲明時考慮這些因素,並不應對這些聲明提供任何修訂或更新,無論是因爲新信息、未來發展還是其他原因的變化,除非法律另有規定。
Oragenics, Inc.
Janet Huffman, Chief Financial Officer
813-286-7900
jhuffman@oragenics.com
Oragenics, Inc.
Janet Huffman,首席財務官
813-286-7900
jhuffman@oragenics.com
Investor Relations:
Rich Cockrell
CG Capital
404-736-3838
ogen@cg.capital
投資者關係:
Rich Cockrell
CG資本
404-736-3838
ogen@cg.capital
Released August 21, 2024
於2024年8月21日發佈
譯文內容由第三人軟體翻譯。
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