Liraglutide Processed With DehydraTECH to Be Studied in Human GLP-1 Study #5
Liraglutide Processed With DehydraTECH to Be Studied in Human GLP-1 Study #5
Positive results in recent animal study strongly support first-ever human investigation for DehydraTECH-liraglutide
最近動物研究的積極結果強烈支持首個針對DehydraTECH-利拉魯肽的人類研究。
KELOWNA, BC / ACCESSWIRE / December 9, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce the engagement of a contract research organization ("CRO") to design and execute a human pilot study evaluating DehydraTECH-liraglutide against Saxenda injectable liraglutide.
KELOWNA, BC / ACCESSWIRE / 2024年12月9日 / Lexaria Bioscience Corp. (納斯達克:LEXX)(納斯達克:LEXXW)("公司"或"Lexaria"),一家全球藥物輸送平台的創新者,很高興宣佈已聘請一家合同研究機構("CRO")來設計和執行一項人類初步研究,評估DehydraTECH-利拉魯肽與Saxenda注射型利拉魯肽的比較。
As reported on November 20th in Lexaria's 12-week rodent study with unlimited food available, DehydraTECH-processed liraglutide - administered orally - demonstrated a 5.88% weight reduction and 11.54% blood sugar reduction compared to baseline. The Rybelsus (semaglutide) control, which was expected to outperform liraglutide, instead produced a 5.65% increase in body weight and 0.41% blood sugar reduction compared to baseline during the same 12 weeks.
據報道,在Lexaria的12周齧齒動物研究中,提供無限量食物,DehydraTECH處理的利拉魯肽(口服給藥)與基線相比,顯示出體重減少5.88%和血糖降低11.54%。預期會優於利拉魯肽的Rybelsus(塞馬魯肽)對照組,在同樣的12周內卻產生了體重增加5.65%和血糖降低0.41%的結果。
As a result of the stronger than expected performance of DehydraTECH-processed liraglutide, the Company has made the decision to investigate further with human study GLP-1-H25-5 expected to be conducted with 8-10 healthy volunteers (the "Study"). The goal of the Study will be to demonstrate safety and test pharmacokinetic performance in humans with an oral version of DehydraTECH-processed liraglutide. If positive, it could support a future decision to investigate DehydraTECH-liraglutide in a future Phase I registered trial.
由於DehydraTECH處理的利拉魯肽的表現強於預期,公司決定進一步研究GLP-1-H25-5人類研究,預計將與8-10名健康志願者進行("研究")。研究的目標是演示安全性並測試DehydraTECH處理的利拉魯肽口服版本在人體內的藥代動力學特性。如果結果積極,這可能支持未來在註冊I期試驗中研究DehydraTECH-利拉魯肽的決定。
Liraglutide is currently sold only in an injectable form under the brand names Saxenda and Victoza, both manufactured by Novo Nordisk. Despite the launch of a genericized version of liraglutide by Teva during 2024, liraglutide sold by Novo Nordisk under the brand name of Saxenda still generated US$849 million in the first half of 2024; and under the brand name Victoza, generated an additional US$1.6 billion in recent annual revenue.
利拉魯肽目前僅以注射形式銷售,品牌名稱爲Saxenda和Victoza,均由諾和諾德製造。儘管Teva在2024年推出了利拉魯肽的仿製版本,諾和諾德旗下品牌Saxenda在2024年上半年仍產生了84900萬美元的營業收入;而Victoza品牌則在最近的年度營業收入中產生了額外的16億美元。
"Liraglutide is a multi-billion dollar annual market-size opportunity," said Richard Christopher, CEO of Lexaria. "Several months ago, the US FDA authorized the first generic version of liraglutide, and Lexaria feels that if we are able to demonstrate similar, or superior, delivery of liraglutide via an oral capsule or tablet, we could provoke additional new revenue opportunities for this important GLP-1 drug."
"利拉魯肽是一個數十億美元的年度市場機會," Lexaria首席執行官Richard Christopher表示。"幾個月前,美國FDA授權了利拉魯肽的首個仿製版本,Lexaria認爲,如果我們能夠證明通過口服膠囊或片劑輸送利拉魯肽的效果相似或更優,我們可能會爲這一重要的GLP-1藥物帶來額外的營業收入機會。"
Approved for use by diabetics to control blood sugar, liraglutide has also evidenced an ability to slow cognitive decline in a Phase 2b clinical trial, and reduce shrinkage of those areas of the brain that control memory, learning, and language by nearly 50% as compared to placebo.
批准糖尿病患者使用的利拉魯肽已經在20億的臨床試驗中顯示出減緩認知衰退的能力,並且與安慰劑相比,減少控制記憶、學習和語言的大腦區域的萎縮近50%。
Development of the Study protocol is underway and Lexaria and the CRO are evaluating options for selection of the clinical site and jurisdiction in which to perform this Study, which has not yet been determined. Further updates will be provided in due course when Lexaria has obtained the necessary ethics board approval before the Study can begin.
研究方案的發展正在進行中,Lexaria和合同研究組織正在評估選擇臨床站點和進行該研究的司法管轄區的期權,這尚未確定。進一步的更新將在Lexaria獲得必要的倫理委員會批准後提供,才能開始研究。
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.是一家專營藥物輸送技術的公司。它的DehydraTECH™專利技術通過促進更健康的口服攝取方法和提高脂溶性活性分子的有效性來改善活性藥物成份(APIs)進入血液流的方式,從而降低總體劑量。該技術可應用於許多不同的可攝入產品格式,包括食品、飲料、口服懸液、片劑和膠囊。自2016年以來,DehydraTECH已經多次證明了與大麻和尼古丁相結合時,它可以將生物吸收率提高5-10倍,將起效時間從1-2小時縮短到幾分鐘,並遮蔽令人不快的口感。計劃酌情對口服生物活性分子進行進一步評估,包括抗病毒劑、大麻二酚類、維生素、非甾體抗炎藥(NSAIDs)和尼古丁製品。Lexaria已經將DehydraTECH出讓了多家公司,包括一家世界領先的生產無煙、基於口腔的尼古丁產品的菸草生產商,並用於生產大麻素飲料、食品和口服制品的行業。Lexaria擁有獲得19項專利授權和約60項世界各地待批准專利的強大知識產權組合。有關更多信息,請訪問www.lexariabioscience.com。
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit .
Lexaria Bioscience Corp.的專利藥物遞送技術DehydraTECH可改善藥物活性成分(APIs)進入血液的方式,促進更有效的口服給藥。自2016年以來,DehydraTECH已多次證明其能夠提高大麻素、抗病毒藥物、GLP-1等藥物的生物吸收能力。DehydraTECH還證明了能夠更有效地跨越血腦屏障傳遞一些藥物。Lexaria經營着持有46項已授予專利和許多在全球範圍內待批准專利的強大知識產權組合的授權內部研究實驗室。欲知更多信息,請訪問 。
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
關於前瞻性聲明的警告
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
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INVESTOR CONTACT:
投資者聯繫方式:
George Jurcic - Head of Investor Relations
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
George Jurcic—投資者關係負責人
ir@lexariabioscience.com
電話: +1-250-765-6424, 分機202
SOURCE: Lexaria Bioscience Corp.
來源:Lexaria Bioscience Corp.
譯文內容由第三人軟體翻譯。