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KELOWNA, BC / ACCESSWIRE / August 30, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is providing this update on the status of the Company's anticipated submission of an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") for its planned U.S. Phase 1b Hypertension Clinical Trial designated as HYPER-H23-1. As previously reported, work that was mostly under Lexaria's control such as batch manufacturing of DehydraTECH™-processed cannabidiol and placebo materials necessary for the IND application filing was completed earlier this year, followed by analytical release and ongoing stability testing. In parallel, compilation of the large set of documentation necessary for inclusion in the IND filing has been progressing on time by the Company and its service providers. However, work that is outside of Lexaria's control, namely the provision of required documentation by one of Lexaria's material suppliers related to their analytical and stability testing of their material, has been delayed. Accordingly, Lexaria is not in a position to submit the IND package to the FDA for their review and consideration until these delays have been cured by the supplier. Lexaria is in communication with its material supplier to provide their required information as soon as possible but, as at the current date, we have not received the results nor an estimated time of receipt for same. Lexaria continues to finalize the IND application so that the Company is in a position to the FDA as soon as possible following receipt of the outstanding information and will provide updated details regarding the status of its IND application filing as they become available. Background and Medical/Market Rationale Lexaria's five previous human clinical studies of DehydraTECH-CBD in hypertension conducted from 2018 through 2022, which were not conducted under FDA-registration but are integral to successful filing and review of its planned IND submission, were carried out in an aggregate total of 134 healthy and hypertensive persons. These foundational studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens, and also produced zero serious adverse events; suggesting that DehydraTECH-CBD has the potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics. Lexaria is aware of only a handful of other published research studies, mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this. DehydraTECH-CBD is currently unique in its evidenced superior power to reduce blood pressure over other oral CBD formulations. Findings from Lexaria's latest study HYPER-H21-4 demonstrated a potentially novel mechanism of action of DehydraTECH-CBD in reducing blood pressure which may be explained, at least in part, by its interaction with the human sympatho-chromaffin system via catestatin modulation as detailed in thepeer-reviewed and published respected journal, "Biomedicine and Pharmacotherapy". This is significant because the FDA has previously laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer novel and complementary modes of action. Data gathered from study HYPER-H21-4 suggested that DehydraTECH-CBD had the potential to offer additive blood pressure reduction benefits on top of any degree of improvements that standard of care medications achieved for patients prior to DehydraTECH-CBD dosing. About Planned Clinical Trial HYPER-H23-1 Clinical trial HYPER-H23-1 is entitled ‘A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension'. The primary objective of the trial will be to evaluate safety and tolerability in hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing. All clinical, laboratory and analysis procedures for study HYPER-H23-1 are to be performed entirely by U.S.-based, third-party independent contract service providers. About DehydraTECH DehydraTECH is a patented drug delivery formulation and processing platform technology Lexaria has developed and is investigating for a variety of beneficial molecules. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules into brain tissue, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria has also developed DehydraTECH formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically. About Lexaria Bioscience Corp. Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors 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 35 patents granted and many patents pending worldwide. For more information, please visit . CAUTION REGARDING FORWARD-LOOKING STATEMENTS 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. INVESTOR CONTACT: George Jurcic - Head of Investor Relations ir@lexariabioscience.com Phone: 250-765-6424, ext 202 SOURCE: Lexaria Bioscience Corp. View source version on accesswire.com:

药物研发进展 1.康希诺生物重组带状疱疹疫苗CS-2032在加拿大获批临床 7月23日，康希诺生物发布公告称，其与Vaccitech公司合作开发的重组带状疱疹疫苗（腺病毒载体）（CS-2032带状疱疹疫苗）已获得加拿大卫生部的临床试验批准。该疫苗目标人群为50岁以上成年人，适用于预防水痘-带状疱疹病毒引起的皮肤带状疱疹和神经痛。带状疱疹是由潜伏在体内的水痘-带状疱疹病毒（VZV）再激活而引起的一种急性感染性皮肤疾病。儿童时期初次感染VZV引起水痘，感染后病毒进入皮肤的感觉神经末梢，沿着脊髓后根或三叉神经节神经纤维向中心移动，以一种持久潜伏的形式长期存在于脊神经或颅神经感觉神经节中。当人体免疫力低下或受到非特异性刺激后，病毒再次活动，生长繁殖，导致受侵犯的神经节发炎或坏死，产生神经痛。同时，再活动的病毒从一个或数个相邻的神经节沿着相应的感觉神经纤维传播到皮肤，造成单侧分布的红斑基础上的簇集性水泡。在爆发前阶段，患者表现为低热、不适、将发疹部位疼痛、感觉异常；在急性发作期，患者表现为皮疹和疼痛，单侧皮肤表面水疱、红斑、硬结；在慢性期，患者则表现为持续疹后神经痛。根据康希诺生物公告，CS-2032带状疱疹疫苗采用了黑猩猩腺病毒载体技术路线，腺病毒载体疫苗能够同时激发细胞免疫与体液免疫。同时，临床试验产品采用先进的工艺技术及符合国际标准的品质管制和控制体系生产，疫苗全生产过程中不使用任何动物源成分，从而提高了最终产品的安全性。临床前研究数据显示，CS-2032带状疱疹疫苗能够同时激发体液免疫与细胞免疫，体液免疫与葛兰素史克（GSK）的重组带状疱疹疫苗Shingrix没有显著性差异，而系统性细胞免疫水平则显著高于后者，预计CS-2032会具有良好的保护效力。 2.礼来IL-23抑制剂mirikizumab拟纳入突破性治疗品种，治疗克罗恩病 7月24日，中国国家药监局药品审评中心（CDE）官网最新公示，礼来（Eli Lilly and Company）申请的mirikizumab注射液拟纳入突破性治疗品种，拟开发用于治疗中重度活动性克罗恩病（CD）成人患者。公开资料显示，mirikizumab（LY3074828）是一款IL-23抑制剂，目前正在海外开展多项3期临床试验。克罗恩病是一种炎症性肠病（IBD），会导致消化道组织肿胀（发炎），从而引起腹痛、严重腹泻、疲劳、体重减轻和营养不良。在不同人中，克罗恩病导致的炎症会在消化道的不同区域发生，最常见于小肠部位。此外，这种炎症通常会扩散到肠道的深层，严重时可能致命。礼来开发的mirikizumab是一种人源化IgG4单克隆抗体，可与IL-23的p19亚基结合，阻断IL-23介导的炎症反应。作为一种炎性细胞因子，IL-23参与了多个炎症相关的生理过程，被认为与许多免疫介导的慢性疾病有关，也因此成为了许多自身免疫性疾病的治疗靶点。此前，mirikizumab已在治疗中重度克罗恩病的2期临床试验中获得积极结果。这是一项名为SERENITY的随机、双盲、含安慰剂对照试验，主要终点是12周之后内镜缓解率，定义为克罗恩病简化内镜评分（SES-CD）与基线相比降低50%。次要终点包括患者报告结局（PRO）检测的临床缓解，以及安全性。试验达到了主要终点和关键次要终点，与安慰剂相比，mirikizumab在治疗12周后显著降低临床和内镜检测到的疾病活动。在内镜缓解率方面，接受200mg、600mg和1000mg剂量mirikizumab的患者组，缓解率分别为25.8%、37.5%和43.8%，安慰剂组这一数值为10.9%。在PRO临床缓解率方面，接受200mg、600mg和1000mg剂量mirikizumab的患者组，缓解率分别为12.9%、28.1%和21.9%，安慰剂组这一数值为6.3%。 3.正大天晴超5000万美元引进，口服PPAR激动剂拟纳入突破性治疗品种 7月24日，中国国家药监局药品审评中心（CDE）官网最新公示，正大天晴申请的1类新药lanifibranor片拟纳入突破性治疗品种，拟开发用于治疗伴有肝纤维化的非肝硬化非酒精性脂肪性肝炎（NASH）的成人患者。公开资料显示，lanifibranor（拉尼兰诺）是一种口服PPAR激动剂，正大天晴通过一项超5000万美元的合作，获得了该药在大中华区的开发、生产和商业化权利。NASH是非酒精性脂肪性肝病（NAFLD）的更晚期形式，也是导致肝脏相关死亡的主要原因。此外，NASH患者，特别是那些具有更多代谢风险因素的患者，心血管不良事件的风险增加，发病率和死亡率也相应提高。一旦NASH发展为显著的肝纤维化，患者产生不良肝损伤结果的风险急剧上升。Lanifibranor是一种口服过氧化物酶体增殖物激活受体（PPAR）激动剂，可同时激活PPARα、PPARδ和PPARγ，这些受体在调控脂质代谢、炎症反应和纤维化过程中发挥重要作用。该药物通过作用于这三种PPAR亚型来调节脂肪代谢，减轻肝脏炎症和纤维化。此前，美国FDA已授予lanifibranor用于治疗NASH的突破性疗法认定和快速通道资格。在针对NASH的2b期NATIVE试验中，lanifibranor已显示出良好的安全性和耐受性。Lanifibranor 1200mg/天、持续24周的治疗，显著降低了肥胖且经活检证实为NASH患者的SAF-A（脂肪变性、活动性、纤维化的活动度）评分。此外，研究也达到了多个次要终点，包括NASH缓解且纤维化不进展，纤维化分期改善至少1期且NASH无恶化，以及NASH缓解且纤维化分期至少改善1期。此外，lanifibranor治疗还显著改善了血清转氨酶水平，肝损伤、炎症和纤维化的生物标志物，糖化血红蛋白（HbA1c）、脂质水平和胰岛素水平。 4.倍特得诺药业申报肌肉松弛药巴氯芬口服溶液拟纳入优先审评 7月24日，中国国家药监局药品审评中心（CDE）官网公示，倍特得诺药业申报的巴氯芬口服溶液拟纳入优先审评，公开资料显示，巴氯芬是一种中枢肌肉松弛药，它通过作用于脊髓和脑部的GABA受体，降低神经元的兴奋性，减轻肌痉挛和僵硬，并且该药的药效持续时间较长，可以达到12小时。GABA（γ-氨基丁酸）是人脑中的一种主要的抑制性神经递质，能降低中枢神经系统的兴奋性。巴氯芬通过增加GABA的合成和释放，增强其在神经元上的抑制作用，从而降低肌肉张力，达到缓解随意肌痉挛的目的。该产品用于缓解由以下疾病引起的随意肌痉挛：多发性硬化、其他脊髓损伤，例如脊髓肿瘤、脊髓空洞症、运动神经元疾病、横贯性脊髓炎、脊髓创伤性部分切除；也适用于成人和儿童，用于缓解因脑血管意外、脑瘫、脑膜炎、颅脑外伤引起的随意肌痉挛。根据CDE公示信息，该产品为儿童用药新剂型，按“符合儿童生理特征的儿童用药品新品种、剂型和规格”纳入优先审评审批程序。巴氯芬由诺华研发和生产，最早于1973年在意大利上市，是第一个应用于临床的选择性GABAβ受体激动剂。1977年，巴氯芬获FDA批准在美国上市。1980年经PMDA批准在日本上市；1998年经NMPA批准进入中国市场；2005年在欧洲上市。巴氯芬临床选择的剂型有普通片剂、口服混悬剂、注射剂、颗粒剂。 5.Bavarian Nordic RSV疫苗产品III期VANIR研究未达终点，终止产品开发 7月22日，Bavarian Nordic宣布其呼吸道合胞病毒（RSV）疫苗产品MVA-BN RSV在III期VANIR研究中未能显著降低下呼吸道疾病（LRTD）的发生率，因此决定终止该产品的开发计划，并结束与优锐医药的合作关系。MVA-BN RSV是一款以MVA-BN为载体的RSV疫苗，同时编码RSV表面蛋白G蛋白及F蛋白和内部蛋白N蛋白及M2蛋白，旨在刺激广泛的免疫应答。2022年3月，优锐医药以2.25亿美元的总交易额获得该疫苗的中国、韩国、东南亚国家权益。VANIR研究是一项全球性、随机、双盲、安慰剂对照的III期临床试验，共纳入超过20000例60岁及以上的受试者。最终研究结果显示，MVA-BN RSV预防至少2种LRTD症状发生的效力为59%，显著优于安慰剂组。然而，该疫苗预防至少2种LRTD症状发生的效力仅有42.9%，与安慰剂组的数据无显著性差异。Bavarian Nordic总裁兼首席执行官Paul Chaplin说：“MVA-BN RSV在这项关键试验中没有成功达到终点，我们对此感到失望。虽然这一结果出乎意料，并将影响我们的短期增长预期，但我们的商业业务仍然是独特的，因为最近几款产品的销售额强劲增长，这为公司未来几年的盈利增长奠定了坚实的基础。”今年3月，强生的病毒载体RSV疫苗JNJ-64400141亦被终止开发。强生给出的解释是“对投资组合进行审查以确定产品开发优先级以及对RSV疫苗的前景评估后，决定终止RSV成人疫苗项目”，不过，也有外界推测其终止决定可能跟疫苗的预防效果或安全性相关。 6.吉利德终止CD47单抗magrolimab III期研究 7月21日，吉利德宣布，CD47单抗magrolimab联合阿扎胞苷治疗高风险骨髓增生异常综合征（MDS）的III期ENHANCE研究因计划分析结果无效而终止。该研究中的安全性数据与已知的magrolimab概况以及该患者群体中典型的不良事件相符。吉利德建议MDS患者停止使用magrolimab治疗。Magrolimab是一种潜在的first-in-class抗CD47免疫疗法，由吉利德49亿美元收购Forty Seven公司获得，主要作用机制是阻断CD47-信号调节蛋白（SIRPα）之间的抑制性相互作用，增强巨噬细胞和其他吞噬细胞识别和消灭外来细胞和恶性细胞的能力，从而达到阻断癌细胞发出的“别吃我”信号的目的。Magrolimab的临床开发计划涵盖10种潜在适应症，包括正在进行的两项关键试验：ENHANCE-2研究针对TP53突变的急性髓系白血病（AML），ENHANCE-3研究一线治疗不适合接受强化化疗的AML。吉利德开发magrolimab之路并不平坦。2022年1月，由于研究人员报告的可疑意外严重不良反应（SUSARs）在各研究组间存在明显的不平衡，FDA部分暂停了吉利德magrolimab+阿扎胞苷的联合研究。同年4月，吉利德迎来FDA解封。FDA在回顾了每个试验的综合安全性数据后，解除了magrolimab+阿扎胞苷的联合研究的部分临床暂停。“患者的健康和福祉是我们的首要任务，虽然这是一个令人失望的消息，但它证实了治疗HR-MDS所面临的挑战，近20年来，HR-MDS一直没有新的治疗方法获得批准。”吉利德科学首席医学官、医学博士Merdad Parsey表示：“吉利德对为这项研究做出贡献的患者、家属、研究人员和权益团体深表感谢，我们将进一步了解magrolimab并探索其治疗其他癌症的潜力。” 7.HER3 ADC 联用 PD-L1！恒瑞医药联合治疗新方案获批临床 7 月 24 日，恒瑞医药宣布，NMPA 已核准签发 PD-L1 单抗阿得贝利单抗、HER3 ADC 注射用 SHR-A2009 的《药物临床试验批准通知书》，恒瑞将于近期开展临床试验。具体为：阿得贝利单抗联合阿美替尼或 SHR-A2009 加或不加化疗用于晚期实体瘤患者。HER3 ADC 由于 Patritumab deruxtecan（U3-1402，来自第一三共）在 EGFR 突变 NSCLC 适应症上的惊艳表现而受到看好，当前全球仅 17 款 HER3 ADC，进入临床的仅仅 6 款。国内参与者以恒瑞医药（SHR-A2009）、百利天恒（BL-B01D1，EGFR/HER3 双靶点）、映恩生物（DB-1310）和宜联生物（YL202）为代表。SHR-A2009 于 2021 年 8 月首次申请临床，同年10 月公示启动临床，目前有 2 项临床试验登记，恒瑞公告显示，截至目前，相关项目累计已投入研发费用约 4685 万元。从阿得贝利单抗研发思路上看，选择IgG4抗体并进行Fc段改造，可以更加专注作用于靶细胞，避免对免疫细胞的伤害，最终追求疗效和安全性双赢的目标。通过抗体改造，丢弃了抗体上的这些“瑕疵与糟粕”（ADCC和ADCP效应），让阿得贝利单抗更加安全，可谓是“君子弃瑕”，而CAPSTONE-1研究中良好的安全性数据也印证了抗体改造的成功。阿得贝利单抗的注册临床研究CAPSTONE-1结果显示，相较于对照组，阿得贝利单抗联合化疗显著改善患者的总生存期（mOS: 15.3个月vs 12.8个月），降低死亡风险达28%，2年生存率达31.3%（vs 化疗17.2%），且具有良好的安全性，≥3级的免疫相关不良事件（irAE）发生率均不超过1.8%。Patritumab Deruxtecan 也有一项联合疗法临床试验在进行，不过联用的是阿斯利康的三代 EGFR 抑制剂奥希替尼，与恒瑞本次获批临床的 SHR-A2009 联用翰森制药三代 EGFR 抑制剂阿美替尼相似；不过，目前第一三共尚未启动联用 PD-(L)1 的HER3 ADC 临床试验。 行业资讯 超30亿美元！罗氏引进Alnylam的高血压RNAi疗法 7月24日，Alnylam宣布已与罗氏达成战略协议，开发和商业化Alnylam用于治疗高血压的RNAi治疗药物zilebesiran。该合作伙伴关系将促成一个大胆的发展计划，有望打破全球高血压治疗模式，同时推进Alnylam的P5x25战略。根据协议条款，Alnylam将获得3.1亿美元的预付款，并有资格获得额外的付款，包括未来几年的开发里程碑付款，以及监管和销售里程碑付款，潜在交易价值高达28亿美元。Alnylam和罗氏将在美国共同商业化zilebesiran，并平分利润。罗氏获得了zilebesiran在美国以外地区的独家商业化权益，Alnylam以换取zilebesiran在美国以外地区净销售额的低两位数版税。此外，Alnylam将领导首个适应症的联合临床开发计划，罗氏有权参与其中，包括在zilebesiran提交监管机构批准之前的心血管结果试验，所有开发成本由Alnylam（40%）和罗氏（60%）共同分担。罗氏可能在未来领导其他适应症的开发。Zilebesiran是一款靶向肝脏表达血管紧张素原（angiotensinogen，AGT）的RNAi药物，目前处于II期开发阶段。7月19日，Zilebesiran治疗高血压的I期研究结果在NEJM杂志上正式发表。该论文报告的关键数据显示，在I期研究中，与安慰剂相比，zilebesiran与血清AGT的剂量依赖性降低相关，在单剂≥200mg zilebesiran给药后，实现了24小时周期内持续持久的血压降低，且效果持续长达6个月。Alnylam目前正在KARDIA II期临床项目中评估zilebesiran的安全性和有效性，包括作为单药治疗(KARDIA-1)，以及与标准治疗降压药物联合用药(KARDIA-2)，公司预期在2023年中期和年底报告这些试验的结果。