Positive Partial 12-Week Blood Sugar Results From Lexaria's GLP-1 Diabetes Animal Study
Positive Partial 12-Week Blood Sugar Results From Lexaria's GLP-1 Diabetes Animal Study
DehydraTECH-liraglutide and select DehydraTECH-CBD formulations were the top performing blood sugar groups
DehydraTECH-liraglutide和選擇的DehydraTECH-CBD配方是表現最佳的血糖組
KELOWNA, BC / ACCESSWIRE / October 24, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received partial 12-week (final) blood sugar results from the recently completed animal study WEIGHT-A24-1 (the "Study").
BC KELOWNA / ACCESSWIRE / 2024年10月24日 / 全球創新藥物輸送平台的 Lexaria Bioscience corp(NASDAQ: LEXX)(NASDAQ: LEXXW)(以下簡稱「公司」或「Lexaria」)宣佈,公司已收到最近完成的動物研究WEIGHt-A24-1(「研究」)的部分爲期12周(最終)血糖結果。
Blood Sugar Levels (mmol/L) | |||||||
DehydraTECH |
Day 7 |
Day |
% |
Day 56 |
% |
Day 84 |
% |
A: CBD1 |
27.4 |
26.2 |
-4.31% |
26.9 |
-1.90% |
27.7 |
1.09% |
B: CBD2 |
28.4 |
29.2 |
2.73% |
26.6 |
-6.22% |
27.3 |
-3.76% |
C: CBD3 |
26.4 |
24.9 |
-5.99% |
27.1 |
2.46% |
27.5 |
3.85% |
D: CBD4 |
24.6 |
27.9 |
13.16% |
26.8 |
8.94% |
27.0 |
9.75% |
E: Rybelsus1 |
26.4 |
25.5 |
-3.60% |
26.8 |
1.33% |
26.8 |
1.59% |
w/SNAC | |||||||
F: Rybelsus2 |
24.9 |
26.8 |
7.70% |
26.4 |
5.96% |
27.3 |
9.58% |
w/SNAC | |||||||
G: Semaglutide |
26.3 |
25.9 |
-1.52% |
27.8 |
5.54% |
26.9 |
2.13% |
No SNAC | |||||||
H: Liraglutide |
26.4 |
25.8 |
-2.08% |
25.2 |
-4.56% |
23.3 |
-11.54% |
No SNAC |
血糖水平(mmol/L) | |||||||
DehydraTECH |
第7天 |
日 |
% |
第56天 |
% |
第84天 |
% |
A: CBD1 |
27.4 |
26.2 |
-4.31% |
26.9 |
-1.90% |
27.7 |
1.09% |
B: CBD2 |
28.4 |
29.2 |
2.73% |
26.6 |
-6.22% |
27.3 |
-3.76% |
C: CBD3 |
26.4 |
24.9 |
-5.99% |
27.1 |
2.46% |
27.5 |
3.85% |
D: CBD4 |
24.6 |
27.9 |
13.16% |
26.8 |
8.94% |
在2023年9月30日結束的9個月和2022年,公司分別減記了股份補償費用$百萬。這是由於員工離職而導致的放棄活動。 |
9.75% |
E: Rybelsus1 |
26.4 |
25.5 |
-3.60% |
26.8 |
1.33% |
26.8 |
1.59% |
w/SNAC | |||||||
F: Rybelsus2 |
24.9 |
26.8 |
7.70% |
26.4 |
5.96% |
27.3 |
9.58% |
w/SNAC | |||||||
全球: Semaglutide |
26.3 |
25.9 |
-1.52% |
27.8 |
5.54% |
26.9 |
2.13% |
No SNAC | |||||||
H:利拉谷肽 |
26.4 |
25.8 |
-2.08% |
25.2 |
-4.56% |
23.3 |
-11.54% |
No SNAC |
Notes
票據
- Groups A through D were different DehydraTECH-CBD compositions
- A至D組採用不同的DehydraTECH-CBD組合藥品
- Groups E and F were reformulated Rybelsus DehydraTECH compositions
- E和F組採用重新配製的Rybelsus DehydraTECH組合藥品
- Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) in DehydraTECH compositions
- G和H組使用純GLP-1藥品(分別是semaglutide和liraglutide)的DehydraTECH組合藥品
- Recalculations led to slight changes from earlier reported data
- 重新計算導致與早前報告的數據有輕微的變化
Lexaria is strongly encouraged that the DehydraTECH-liraglutide and DehydraTECH-CBD groups A and B outperformed all three of the Rybelsus and pure semaglutide DehydraTECH composition groups regardless of whether the semaglutide had or had not been processed with the salcaprozate sodium technology known as "SNAC". Rybelsus, which utilizes Novo Nordisk's proprietary SNAC technology, is the world's only orally administered GLP-1 drug brand.
Lexaria強烈鼓勵DehydraTECH-liraglutide和DehydraTECH-CBD A和B組表現優於所有三種Rybelsus和純semaglutide DehydraTECH組合的組,無論semaglutide是否已經經過被稱爲"SNAC"的salcaprozate sodium技術的處理。Rybelsus採用諾和諾德專有的SNAC技術,是全球唯一一種口服GLP-1藥品品牌。
Study data for four additional animal groups (I, J, K, and L), including a positive control group of Rybelsus that has not been processed with DehydraTECH, will be available soon. Of the eight Study groups reported on today, DehydraTECH-CBD group B and the sole DehydraTECH-liraglutide group H were both successful in reducing blood sugar levels, while the other six groups, including all three of the Rybelsus and pure semaglutide DehydraTECH composition groups, were not.
將很快公佈四個額外的動物組(I、J萬和L)的研究數據,包括一個未經DehydraTECH處理的Rybelsus陽性對照組。在今天報道的八個研究組中,DehydraTECH-CBD B組和唯一的DehydraTECH-liraglutide H組在降低血糖水平方面都取得了成功,而其他六組,包括所有三種Rybelsus和純semaglutide DehydraTECH組合的組,均未成功。
This Study is the world's first to evaluate the relative performance of liraglutide processed with DehydraTECH. Thus, the outperformance of DehydraTECH-liraglutide compared to the other groups is of notable interest and was unexpected. In this Study, the processed liraglutide in Study group H was administered orally even though it is injected when used by patients under the brand names Saxenda or Victoza.
這項研究是世界上第一個評估通過DehydraTECH處理的liraglutide相對錶現的研究。因此,DehydraTECH-liraglutide相較於其他組的表現引人注目且出乎意料。在本研究中,H組的處理liraglutide是經口服給予的,即使在患者使用品牌名稱Saxenda或Victoza注射時也是如此。
Usually, injected versions of drugs have greater efficacy than orally administered versions of the same drug because of superior pharmacokinetics ("PK"). Lexaria's DehydraTECH drug delivery technology has historically enhanced the PK of orally administered drugs, opening a potential for viability in commercial markets.
通常,注射劑對藥物的效力比口服劑更高,因爲具有更好的藥物代謝動力學("PK")。Lexaria的DehydraTECH藥物傳遞技術在歷史上提高了口服藥物的PK,爲商業市場的可行性打開了潛力。
Additional data from this Study is pending, including body weight and blood glucose findings from the second Study cohort that included positive and vehicle (placebo) control arms. Analyses of brain and blood absorption pharmacokinetic results is also underway, although unforeseen delays at the third-party laboratories involved is affecting timing of completion of this work. Lexaria is working with these laboratories to minimize further delays and will report on these data as soon as possible.
待該研究中的額外數據包括第二研究隊列中身體重量和血糖發現,該隊列包括陽性和載體(安慰劑)對照組。大腦和血液吸收藥代動力學結果的分析也正在進行中,儘管涉及的第三方實驗室出現意外延遲影響了完成這項工作的時間。Lexaria正在與這些實驗室合作,儘量減少進一步延遲,並將儘快報告這些數據。
About the Study
關於該研究
Study WEIGHT-A24-1 was completed using diabetic, pre-conditioned Zucker rats. Each arm of the Study was dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples were collected from the total starting rat population of 72 animals for purposes of detailed PK drug delivery analyses. Because of the small animal population in each Study arm, statistical significance is not expected and instead, commentary on apparent trends has been noted. Body weight and blood glucose readings were taken prior to Study start continuing at regular intervals during and at conclusion of the dosing period. Upon completion of the Study, brain tissue will be analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH arms, as Lexaria has evidenced numerous times in previous similar animal studies. The Study will also include a comprehensive battery of liver and kidney function testing and blood chemistry analyses. LC-MS/MS and other techniques will be used to analyse samples. All animal groups were offered unlimited access to food throughout the course of the Study.
WEIGHt-A24-1研究使用糖尿病、預處理的Zucker大鼠完成。研究的每個分支都在最初的適應期後進行了爲期12周的投藥。在研究期間,從總起始大鼠種群中的72只動物中收集了1500多個血漿樣本,以進行詳細的PK藥物傳遞分析。由於每個研究分支中的小動物群體,不會產生統計學顯著性,而是對明顯趨勢進行了評論。研究開始前及投藥期間的定期間隔,以及投藥期結束時進行了身體重量和血糖測量。研究完成後,將分析大腦組織以幫助判斷DehydraTECH處理是否導致更高的大腦吸收量,正如Lexaria在先前類似的動物研究中多次證明的那樣。該研究還將包括全面的肝臟和腎功能測試以及血液化學分析。將使用LC-MS/MS等技術來分析樣本。在整個研究過程中,所有動物組都可以隨時獲得食物。
About Lexaria Bioscience Corp. & DehydraTECH
關於Lexaria Bioscience Corp.和DehydraTECH
DehydraTECH is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. 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 .
DehydraTECH是Lexaria專有的藥物遞送配方及處理平台技術,通過口服途徑改善了活性藥物成分(APIs)進入血液的方式。自2016年以來,Lexaria已經開發和研究了DehydraTECH,並嘗試將其應用在口服和局部使用中的多種有益分子中。DehydraTECH已經反覆證明了其增強吸收率的功能,並且還證明了一些藥物穿過血腦屏障的能力,Lexaria認爲這對於對中樞活性化合物特別重要。Lexaria在業內擁有一個許可證的內部研究實驗室,並擁有一份完整的專利組合,其中46項獲得授權的專利和許多在全球尚待獲得授權。欲了解更多信息,請訪問公司網站。
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 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.
本新聞稿包含前瞻性聲明。這些語句可能會由"anticipate","if","believe","plan","estimate","expect","intend","may","could","should","will"和其他類似表達方式標識。本新聞稿中的此類前瞻性聲明包括但不限於,公司聲明與公司的能力有關的研究計劃,獲得監管批准或資助或從研究或研究中體驗積極效果或結果。此類前瞻性聲明是基於現有信息的估算,涉及一些風險和不確定性,公司不能保證公司實際上將實現這些前瞻性聲明中披露的計劃,意圖或期望。因此,您不應過度依賴這些前瞻性聲明。可能導致公司估計結果與實際結果存在實質性差異的因素包括但不限於,政府法規和監管批准,管理和保持增長,不良宣傳的影響,訴訟,競爭,科學發現,專利申請和獲批過程,可能由於測試或使用利用DehydraTECH技術的產品而產生的潛在不良影響,公司能否維護現有的合作關係並實現相應的收益,可能因大流行病或其他原因而導致的計劃研究和開發活動的延誤或取消以及其他可能隨時在公司的公告和美國證券交易委員會在EDGAR上的定期申報中被確定的因素。公司僅作爲對讀者的禮貌提供鏈接到第三方網站,並不對第三方網站上的信息的廣度,準確性或時效性負責。沒有保證,Lexaria的任何猜想用途,優點或利益的專利和申請專利的技術事實上會以任何方式或部分體現出來。本文中的任何聲明均未經美國食品和藥物管理局(FDA)評估。與Lexaria相關的產品不旨在診斷,治療,治癒或預防任何疾病。本發佈中涉及的任何前瞻性聲明僅在此發佈日之時,公司明確免責對任何前瞻性聲明或本發佈中的第三方網站鏈接的更新負責,無論是由於任何新信息,未來事件,變化後情況或法律原因。
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.