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和选择的DehydraTECH-CBD配方是表现最佳的血糖组
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 / 全球创新药物输送平台的 Lexaria Bioscience corp(NASDAQ: LEXX)(NASDAQ: LEXXW)(以下简称“公司”或“Lexaria”)宣布,公司已收到最近完成的动物研究WEIGHt-A24-1(“研究”)的部分为期12周(最终)血糖结果。
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日结束的9个月和2022年,公司分别减记了股份补偿费用$百万。这是由于员工离职而导致的放弃活动。 |
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
票据
- Groups A through D were different DehydraTECH-CBD compositions
- A至D组采用不同的DehydraTECH-CBD组合药品
- Groups E and F were reformulated Rybelsus DehydraTECH compositions
- E和F组采用重新配制的Rybelsus DehydraTECH组合药品
- Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively) in DehydraTECH compositions
- G和H组使用纯GLP-1药品(分别是semaglutide和liraglutide)的DehydraTECH组合药品
- Recalculations led to slight changes from earlier reported data
- 重新计算导致与早前报告的数据有轻微的变化
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强烈鼓励DehydraTECH-liraglutide和DehydraTECH-CBD A和B组表现优于所有三种Rybelsus和纯semaglutide DehydraTECH组合的组,无论semaglutide是否已经经过被称为"SNAC"的salcaprozate sodium技术的处理。Rybelsus采用诺和诺德专有的SNAC技术,是全球唯一一种口服GLP-1药品品牌。
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.
将很快公布四个额外的动物组(I、J万和L)的研究数据,包括一个未经DehydraTECH处理的Rybelsus阳性对照组。在今天报道的八个研究组中,DehydraTECH-CBD B组和唯一的DehydraTECH-liraglutide H组在降低血糖水平方面都取得了成功,而其他六组,包括所有三种Rybelsus和纯semaglutide DehydraTECH组合的组,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.
这项研究是世界上第一个评估通过DehydraTECH处理的liraglutide相对表现的研究。因此,DehydraTECH-liraglutide相较于其他组的表现引人注目且出乎意料。在本研究中,H组的处理liraglutide是经口服给予的,即使在患者使用品牌名称Saxenda或Victoza注射时也是如此。
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,注射剂对药物的效力比口服剂更高,因为具有更好的药物代谢动力学("PK")。Lexaria的DehydraTECH药物传递技术在历史上提高了口服药物的PK,为商业市场的可行性打开了潜力。
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.
待该研究中的额外数据包括第二研究队列中身体重量和血糖发现,该队列包括阳性和载体(安慰剂)对照组。大脑和血液吸收药代动力学结果的分析也正在进行中,尽管涉及的第三方实验室出现意外延迟影响了完成这项工作的时间。Lexaria正在与这些实验室合作,尽量减少进一步延迟,并将尽快报告这些数据。
About the Study
关于该研究
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、预处理的Zucker大鼠完成。研究的每个分支都在最初的适应期后进行了为期12周的投药。在研究期间,从总起始大鼠种群中的72只动物中收集了1500多个血浆样本,以进行详细的PK药物传递分析。由于每个研究分支中的小动物群体,不会产生统计学显著性,而是对明显趋势进行了评论。研究开始前及投药期间的定期间隔,以及投药期结束时进行了身体重量和血糖测量。研究完成后,将分析大脑组织以帮助判断DehydraTECH处理是否导致更高的大脑吸收量,正如Lexaria在先前类似的动物研究中多次证明的那样。该研究还将包括全面的肝脏和肾功能测试以及血液化学分析。将使用LC-MS/MS等技术来分析样本。在整个研究过程中,所有动物组都可以随时获得食物。
About Lexaria Bioscience Corp. & DehydraTECH
关于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专有的药物递送配方及处理平台技术,通过口服途径改善了活性药物成分(APIs)进入血液的方式。自2016年以来,Lexaria已经开发和研究了DehydraTECH,并尝试将其应用在口服和局部使用中的多种有益分子中。DehydraTECH已经反复证明了其增强吸收率的功能,并且还证明了一些药物穿过血脑屏障的能力,Lexaria认为这对于对中枢活性化合物特别重要。Lexaria在业内拥有一个许可证的内部研究实验室,并拥有一份完整的专利组合,其中46项获得授权的专利和许多在全球尚待获得授权。欲了解更多信息,请访问公司网站。
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
关于前瞻性声明的警告
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.
本新闻稿包含前瞻性声明。这些语句可能会由"anticipate","if","believe","plan","estimate","expect","intend","may","could","should","will"和其他类似表达方式标识。本新闻稿中的此类前瞻性声明包括但不限于,公司声明与公司的能力有关的研究计划,获得监管批准或资助或从研究或研究中体验积极效果或结果。此类前瞻性声明是基于现有信息的估算,涉及一些风险和不确定性,公司不能保证公司实际上将实现这些前瞻性声明中披露的计划,意图或期望。因此,您不应过度依赖这些前瞻性声明。可能导致公司估计结果与实际结果存在实质性差异的因素包括但不限于,政府法规和监管批准,管理和保持增长,不良宣传的影响,诉讼,竞争,科学发现,专利申请和获批过程,可能由于测试或使用利用DehydraTECH技术的产品而产生的潜在不良影响,公司能否维护现有的合作关系并实现相应的收益,可能因大流行病或其他原因而导致的计划研究和开发活动的延误或取消以及其他可能随时在公司的公告和美国证券交易委员会在EDGAR上的定期申报中被确定的因素。公司仅作为对读者的礼貌提供链接到第三方网站,并不对第三方网站上的信息的广度,准确性或时效性负责。没有保证,Lexaria的任何猜想用途,优点或利益的专利和申请专利的技术事实上会以任何方式或部分体现出来。本文中的任何声明均未经美国食品和药物管理局(FDA)评估。与Lexaria相关的产品不旨在诊断,治疗,治愈或预防任何疾病。本发布中涉及的任何前瞻性声明仅在此发布日之时,公司明确免责对任何前瞻性声明或本发布中的第三方网站链接的更新负责,无论是由于任何新信息,未来事件,变化后情况或法律原因。
INVESTOR CONTACT:
投资者联系方式:
George Jurcic - Head of Investor Relations
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202
George Jurcic—投资者关系负责人
ir@lexariabioscience.com
电话: +1-250-765-6424, 分机202
SOURCE: Lexaria Bioscience Corp.
来源:Lexaria Bioscience Corp.