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BetterLife Continues Progress on BETR-001 IND-Enabling Studies

BetterLife Continues Progress on BETR-001 IND-Enabling Studies

BetterLife 在 BETR-001 IND 支持研究方面继续取得进展
GlobeNewswire ·  2023/06/08 20:00

VANCOUVER, British Columbia, June 08, 2023 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech company focused on the development and commercialization of cutting-edge treatments for mental disorders, today announced that the IND-enabling studies BetterLife's 2-bromo-LSD ("BETR-001") continue to progress. BETR-001 is a non-hallucinogenic Lysergic Acid Diethylamide ("LSD") derivative molecule.

温哥华,不列颠哥伦比亚省,2023年6月8日(环球网)--BetterLife Pharma Inc.(以下简称“BetterLife”或“公司”)(CSE:BETR/OTCQB:BETRF/FRA:NPAU)今天宣布,BetterLife的2-bromo-LSD(“BETR-001”)支持IND的研究继续取得进展。Betr-001是一种非致幻麦角酸二乙酰胺(“LSD”)衍生物分子。

BetterLife has previously completed the preclinical pharmacological profiling of BETR-001, which showed that BETR-001 has robust activity in various depression/anxiety animal models without hallucinogenic activity. The BETR-001 IND-enabling animal toxicology studies are now in various stages of completion. The in-life portion of the 28-day repeat dose GLP toxicology study in dogs has now been completed, and the histopathological analyses are ongoing. The GMP manufacturing of BETR-001 drug substance is also in its final stages.

BetterLife之前已经完成了BETR-001的临床前药理分析,结果表明BETR-001在各种没有致幻活性的抑郁/焦虑动物模型中具有强大的活性。支持BETR-001 IND的动物毒理学研究目前正处于不同的完成阶段。对狗进行的28天重复剂量GLP毒理学研究的活体部分现已完成,组织病理学分析正在进行中。BETR-001药材的GMP生产也已进入最后阶段。

Dr. Ahmad Doroudian, CEO of BetterLife commented, "We are very excited to be about mid-way through the BETR-001 IND-enabling toxicology studies, which are based on the guidance we received from the FDA from our pre-IND meeting. We will file the BETR-001 IND and begin human trials as soon as these IND-enabling studies are completed."

BetterLife公司首席执行官艾哈迈德·多鲁迪安博士评论说:“我们非常高兴能够进行BETR-001 IND毒理学研究,这些研究是基于我们在IND前会议上从FDA得到的指导。一旦这些IND支持研究完成,我们将提交BETR-001 IND并开始人体试验。”

He further added, "The recently published American College of Physician's (ACP) guidelines for the treatment of Major Depressive Disorder (MDD) highlight the scale of MDD and the high unmet medical need. The guidelines say that "in the United States, more than 20% of adults experience MDD in their lifetime, with around 10% experiencing it in a given year", and that the "estimated economic burden attributable to MDD in the United States was $120 billion in 2020". And discussing the current MDD treatments, the guidelines say that primary care physicians are the initial care-providers for MDD, but that "approximately up to 70% of patients with MDD do not achieve remission and remain in the acute phase after the initial pharmacologic treatment attempt." In such a market, we foresee that BETR-001, which is a new treatment class, and non-hallucinogenic and therefore not a regulated substance, will find widespread acceptance and play a key role in helping MDD patients.'

他进一步补充说:“最近出版的美国医师学会(ACP)治疗严重抑郁障碍(MDD)指南强调了MDD的规模和高度未得到满足的医疗需求。该指南称,“在美国,超过20%的成年人在一生中经历过MDD,其中约10%的人在特定年份经历过MDD”,“2020年,美国因MDD造成的经济负担估计为1200亿美元”。在讨论目前的MDD治疗方法时,指南说,初级保健医生是MDD的初始护理提供者,但“大约70%的MDD患者在最初的药物治疗尝试后没有得到缓解,仍然处于急性期。”在这样的市场中,我们预计BETR-001将得到广泛的接受,并在帮助MDD患者方面发挥关键作用。BETR-001是一种新的治疗类别,不会致幻,因此不是一种受管制的物质。“

About BetterLife Pharma

关于BetterLife Pharma

BetterLife Pharma Inc. is an emerging biotechnology company primarily focused on developing and commercializing two compounds, BETR-001 and BETR-002, to treat neuro-psychiatric and neurological disorders.

BetterLife制药公司是一家新兴的生物技术公司,主要致力于开发和商业化两种化合物BETR-001和BETR-002,用于治疗神经精神和神经疾病。

BETR-001, which is in preclinical and IND-enabling studies, is a non-hallucinogenic and non-controlled LSD derivative in development and it is unique in that it is unregulated and therefore can be potentially self-administered. BetterLife's synthesis patent for BETR-001 eliminates regulatory hurdles and its pending patent, for composition and method of use, covers treatment of major depressive disorder, anxiety disorder and neuropathic pain and other neuro-psychiatric and neurological disorders.

Betr-001处于临床前研究和IND使能研究中,是一种开发中的非致幻和非受控LSD衍生物,其独特之处在于它不受监管,因此可以潜在地自我给药。BetterLife的BETR-001合成专利消除了管理障碍,其正在申请的成分和使用方法专利涵盖了治疗严重抑郁症、焦虑症和神经病理性疼痛以及其他神经精神和神经性疾病。

BETR-002, which is in preclinical and IND-enabling studies, is based on honokiol, the active anxiolytic ingredient of magnolia bark. BetterLife's pending method of use and formulations patent covers treatment of anxiety related disorders including benzodiazepine dependency.

Betr-002正在进行临床前和IND的研究,它是基于厚朴酚的,和厚朴酚是厚朴树皮的有效抗焦虑成分。BetterLife正在申请的使用方法和配方专利涵盖了治疗焦虑症相关疾病,包括对苯二氮卓的依赖。

BetterLife also owns a drug candidate for the treatment of viral infections such as COVID-19 and is in the process of seeking strategic alternatives for further development.

BetterLife还拥有一种治疗新冠肺炎等病毒感染的候选药物,并正在寻找进一步发展的战略替代药物。

For further information, please visit BetterLife Pharma.

欲了解更多信息,请访问BetterLife Pharma。

BetterLife Pharma Inc. Contact Information

BetterLife Pharma Inc.联系信息

David Melles, Investor Relations Manager
Email: David.Melles@blifepharma.com
Phone: 1-778-887-1928

投资者关系经理David·梅尔斯
电子邮件:David.Melle@blifepharma.com
电话:1-778-887-1928

Cautionary Note Regarding Forward-Looking Statements

有关前瞻性陈述的注意事项

No securities exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

没有任何证券交易所对本新闻稿内容的充分性或准确性进行审查或承担责任。本新闻稿包含与产品开发、许可、商业化和监管合规问题有关的前瞻性陈述,以及其他非历史事实的陈述。前瞻性陈述通常用“将”、“可能”、“应该”、“预期”、“预期”和类似的表达方式来识别。除历史事实陈述外,本新闻稿中包含的所有陈述均为前瞻性陈述,涉及风险和不确定性。不能保证这些陈述将被证明是准确的,实际结果和未来事件可能与这些陈述中预期的大不相同。可能导致实际结果与公司预期大相径庭的重要因素包括未能满足相关证券交易所的条件以及公司不时提交给证券监管机构的文件中详述的其他风险。提醒读者,在准备任何前瞻性信息时使用的假设可能被证明是不正确的。由于许多已知和未知的风险、不确定性和其他因素,其中许多是公司无法控制的,事件或情况可能会导致实际结果与预测的结果大不相同。提醒读者不要过度依赖任何前瞻性信息。这些信息虽然在准备时被管理层认为是合理的,但可能被证明是不正确的,实际结果可能与预期的大不相同。本新闻稿中包含的前瞻性陈述明确地受到本警示性声明的限制。本新闻稿中包含的前瞻性陈述是截至本新闻稿发布之日作出的,公司将根据适用法律的明确要求,公开更新或修改任何包含的前瞻性陈述。


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