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BetterLife Obtains Positive In Vivo Oral Bioavailability, Food Effect and Pharmacokinetics Data for BETR-001

BetterLife Obtains Positive In Vivo Oral Bioavailability, Food Effect and Pharmacokinetics Data for BETR-001

BetterLife在BETR-001的活體口服生物利用度、食物效應和藥代動力學數據方面取得積極進展
GlobeNewswire ·  2022/01/18 21:10

VANCOUVER, British Columbia, Jan. 18, 2022 (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 2nd-generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, is pleased to announce it has obtained positive results from an in vivo oral bioavailability and food-effect pharmacokinetic (PK) study on BETR-001 in beagle dogs. BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD). Previous published studies have not included any data on PK for BETR-001. It was also unknown if presence of food would affect the bioavailability of orally administered BETR-001. The current study conducted by contract research organization, Nucro-Technics (Scarborough, ON, Canada), demonstrated the following key results after a single dose of oral BETR-001 (capsule) administered to beagle dogs:

温哥華,不列顛哥倫比亞省,2022年1月18日(Global Newswire)--BetterLife Pharma Inc.(以下簡稱“BetterLife”或“公司”)(CSE:BETR/OTCQB:BETRF/FRA:NPAU),一家專注於2-甲氧基苯丙胺的開發和商業化的新興生物科技公司(CSE:BETR/OTCQB:BETRF/FRA:NPAU)發送新一代非致幻迷幻類似物BETR-001用於治療神經心理障礙,我們高興地宣佈,BETR-001在Beagle犬的體內口服生物利用度和食物效應藥代動力學(PK)研究取得了積極結果。Betr-001(2-溴-LSD,前身為TD-0148A)是一種麥角酸二乙酰胺(LSD)的非致幻衍生物。以前發表的研究沒有包括任何關於BETR-001的PK的數據。食物的存在是否會影響口服BETR-001的生物利用度也是未知的。目前由合同研究機構Nucro-Technics(加拿大安大略省斯卡伯勒)進行的這項研究,在給比格犬口服單劑量BETR-001(膠囊)後,證明瞭以下關鍵結果:

  • No significant difference was observed in bioavailability and total exposure of BETR-001 in PK profile of fed versus fasted beagle dogs.
  • Oral bioavailability (%F), defined as the fraction of oral administered drug that reaches systemic circulation, was calculated to be 61% and 63% for fasted and fed states, respectively (no significant difference).
  • The maximum systemic concentration (Cmax) of BETR-001 after a single oral dose was reached at 0.5 hr (Tmax), suggesting a quick uptake of the drug into the systemic circulation. The drug was detectable in systemic circulation eight hours post oral dose with an elimination rate constant (Kel) of 0.4 per hour, pointing to the fraction of drug eliminated per unit of time.
  • BETR-001在餵食和禁食的比格犬的PK譜中的生物利用度和總暴露沒有顯著差異。
  • 口服生物利用度(%F),即口服藥物到達體循環的比例,在禁食和進食狀態下分別計算為61%和63%(無顯著差異)。
  • 最大全身濃度(C最大值BETR-001在0.5小時(T)達到單次口服劑量後的BETR-001最大值),這表明藥物被迅速吸收到體循環中。口服後8小時可在體循環中檢測到藥物,消除速率常數(KEL)為每小時0.4,指的是每單位時間消除的藥物的比例。

The findings demonstrate that oral administration of a single dose of BETR-001 can reach the therapeutic range in the systemic circulation. The PK elimination constant (Kel) of 0.4 per hour for BETR-001 indicates a low probability of toxicity as a result of drug accumulation in the systemic circulation.
"We are very pleased with the results of the first oral PK study for BETR-001 drug manufactured by BetterLife's patented synthesis and formulation process. Although 2-bromo-LSD has been tested in rodents and human studies in the past, this is the first study to characterize its PK profile in vivo", stated BetterLife's Chief Executive Officer, Dr. Ahmad Doroudian. He added, "These data, together with the ongoing IND-enabling nonclinical toxicology studies, will support the filing of BETR-001's IND application with the FDA and initiation of human clinical trials in H2 2022."

結果表明,口服單劑BETR-001可達到體循環治療範圍。PK消除常數(KELBETR-001為0.4/小時,表明由於藥物在體循環中蓄積而產生毒性的可能性很低。
BetterLife公司首席執行官艾哈邁德·多魯迪安博士説:“我們對BetterLife公司專利合成和配方工藝生產的BETR-001藥物的首次口服PK研究結果感到非常高興。儘管2-bromo-LSD過去曾在齧齒類動物和人體研究中進行過測試,但這是第一次在活體內描述其PK特徵的研究。”他補充説,“這些數據,加上正在進行的支持IND的非臨牀毒理學研究,將支持BETR-001向FDA提交IND申請,並在2022年下半年啟動人類臨牀試驗。”

About BetterLife Pharma

關於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製藥公司是一家新興的生物技術公司,主要致力於開發和商業化兩種化合物BETR-001和BETR-002,用於治療神經精神和神經疾病。

BETR-001 (formerly TD-0148A), 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 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 depression, cluster headaches, post-traumatic stress disorder and other neuro-psychiatric and neurological disorders.

Betr-001(前身為TD-0148A)正在進行臨牀前和IND支持研究,是一種正在開發中的非致幻和非受控LSD衍生物,其獨特之處在於它不受監管,因此可以自我給藥。BetterLife用於BETR-001的合成專利消除了管理障礙,其正在申請的組合物和使用方法專利涵蓋治療抑鬱症、叢集性頭痛、創傷後應激障礙和其他神經精神和神經紊亂。

BETR-002 (formerly TD-010), 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(前身為TD-010)是基於厚朴樹皮中的有效抗焦慮成分和厚朴酚,正在進行臨牀前和IND研究。BetterLife正在申請的使用方法和配方專利涵蓋了治療焦慮症相關疾病,包括對苯二氮類藥物的依賴。

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還擁有一種治療新冠肺炎等病毒感染的候選藥物,目前正在尋找進一步發展的戰略替代藥物。

For further information, please visit BetterLife Pharma.

欲瞭解更多信息,請訪問BetterLife Pharma。

Contact Information

聯繫信息

David Melles, Investor Relations Manager
Email: David.Melles@blifepharma.com

投資者關係經理大衞·梅爾斯(David Melle)
電子郵件:David.Melle@blifepharma.com

Phone: 1-778-887-1928

電話:1-778-887-1928

Cautionary Note Regarding Forward-Looking Statements

有關前瞻性陳述的注意事項

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.

沒有任何證券交易所對本新聞稿內容的充分性或準確性進行審查或承擔責任。本新聞稿包含與產品開發、許可、商業化和法規遵從性問題有關的前瞻性陳述,以及其他非歷史事實的陳述。前瞻性陳述通常由諸如“將”、“可能”、“應該”、“預期”、“期望”和類似的表達方式來識別。本新聞稿中除歷史事實陳述外的所有陳述均為前瞻性陳述,涉及風險和不確定因素。不能保證這些陳述將被證明是準確的,實際結果和未來事件可能與這些陳述中預期的大不相同。可能導致實際結果與本公司預期大相徑庭的重要因素包括未能滿足相關證券交易所的條件以及本公司不時提交給證券監管機構的文件中詳細説明的其他風險。提醒讀者,在準備任何前瞻性信息時使用的假設可能被證明是不正確的。由於許多已知和未知的風險、不確定性和其他因素,其中許多不是公司所能控制的,事件或情況可能導致實際結果與預測的結果大不相同。提醒讀者不要過度依賴任何前瞻性信息。這些信息,儘管管理層在準備時認為是合理的, 可能被證明是不正確的,實際結果可能與預期的大不相同。本新聞稿中包含的前瞻性陳述明確受本警告性聲明的限制。本新聞稿中包含的前瞻性陳述是截至本新聞稿發佈之日作出的,公司將根據適用法律的明確要求,公開更新或修改任何包含的前瞻性陳述。


譯文內容由第三人軟體翻譯。


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