EXCLUSIVE: Oragenics Completes Key FDA-Recognized Study For Concussion Drug Candidate
EXCLUSIVE: Oragenics Completes Key FDA-Recognized Study For Concussion Drug Candidate
The model is standard for intranasal drug delivery and is accepted by the FDA as a surrogate for the actual nasal passage.On Tuesday, Oragenics Inc. (NYSE:OGEN) said it has completed a key study for its new concussion drug, ONP-002.
週二，oragenics股份有限公司（NYSE：OGEN）表示其已完成了新型腦震藥物ONP-002的關鍵研究。
What Happened: A recent study shows that the drug successfully targets areas inside the nose connected to the brain, making the drug more likely to reach and treat the brain after a concussion.
發生了什麼：最近的研究顯示，該藥物成功地針對了與大腦相連的鼻內區域，使得藥物更有可能在腦震後到達和治療大腦。
In the study, ONP-002 was tested using a nasal spray device. The goal of intranasal casting studies is to identify where the drug lands inside a cast metal anatomical model of the interior nose.
在這項研究中，使用鼻噴設備測試了ONP-002。顱內噴射研究的目標是確定藥物着陸在頭部鑄造金屬解剖模型的何處。
The model is standard for intranasal drug delivery and is accepted by the FDA as a surrogate for the actual nasal passage.
該模型是用於顱內藥物傳遞的標準，並被FDA接受爲實際鼻腔通道的替代品。
The results showed that the drug spreads well in the nose areas, where it can be quickly absorbed into the brain.
結果顯示，藥物在鼻部區域傳播很好，可以迅速被大腦吸收。
Also Read: EXCLUSIVE: Oragenics Completes Spray Dry Drug Manufacturing, Intranasal Device Filling For Anticipated Mid-Stage Study For Patients With Brain Injury.
另請參閱：獨家報道：Oragenics完成了噴霧乾燥製藥，鼻內裝置充填，爲預期的中期研究爲腦損傷患者做準備。
Why It Matters: Oragenics is now preparing to move forward with human testing (Phase 2) in patients who come to the emergency room with a concussion, aiming to give the first dose of the drug within 8 hours of the injury.
爲什麼重要：oragenics現在正在準備推進在急診室中出現腦震的患者的人體測試（第2階段），旨在在受傷後8小時內給藥的第一劑。
"In preparing for our Phase 2 study, we wanted to study whether our nasal spray device would give ONP-002 an increased chance of reaching the brain quickly after a concussion. The study results are promising, as they show the drug targets areas in the nose directly linked to the brain. This should increase the chances of the drug being effective in treating concussion and reduces the likelihood of it being swallowed, which is another encouraging sign," said Michael Redmond, President of Oragenics.
"在準備我們的第2階段研究時，我們想研究我們的鼻噴設備是否會使ONP-002在腦震後更有機會迅速到達大腦。研究結果是令人鼓舞的，因爲它們顯示藥物針對與大腦直接連接的鼻部區域。這應該增加藥物在治療腦震時的有效性，並降低吞嚥可能性，這是另一個令人鼓舞的跡象，"oragenics總裁Michael Redmond說。
In August, Oragenics completed a study that indicates ONP-002 does not cause cardiotoxicity.
oragenics在八月完成了一項研究，表明ONP-002不會造成心臟毒性。
A concussion is a mild traumatic brain injury that affects brain function, with an estimated 69 million cases reported annually worldwide.
腦震盪是一種輕微的顱腦損傷，影響腦功能，全球每年報告約6900萬例。
Long-term symptoms can develop in up to 20% of patients. Currently, there is no pharmaceutical treatment for concussions.
長期症狀可能發展到患者的20%。目前腦震盪沒有藥物治療。
Price Action: OGEN stock closed at $0.39 on Monday.
股價走勢：OGEN股票週一收盤價爲0.39美元。
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譯文內容由第三人軟體翻譯。
