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Lobe Sciences Provides an Update to Clinical Development Plans for Its Proprietary Psilocin Product, L-130

Lobe Sciences Provides an Update to Clinical Development Plans for Its Proprietary Psilocin Product, L-130

波葉科學公司為其專利產品L-130提供臨牀開發計劃的更新
newsfile ·  2022/11/30 22:15

Vancouver, British Columbia--(Newsfile Corp. - November 30, 2022) - Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced an update for its clinical development plans for its proprietary Psilocin based compound L-130.

不列顛哥倫比亞省温哥華-(Newsfile Corp.-2022年11月30日)-致力於發現和開發治療神經和腦部疾病的迷幻衍生藥物的北美生物製藥公司LOPE Sciences Ltd.(CSE:LOPE)(場外交易市場代碼:LOBEF)(以下簡稱“LOPE”或“公司”)今天宣佈,其基於PsiLocin的專利化合物L-130的臨牀開發計劃更新。

Philip J. Young, Chairman and Chief Executive Officer of the Company stated, "Subsequent to our last communication on the cGMP production of L-130, I wanted to update our stakeholders on our progress as we advance into our Phase 1 clinical trials. We have received regulatory clearance to conduct our Phase 1 study which is a combination of safety and pharmacokinetics evaluation of a fixed dose of L-130." Young continued, "It is important to remember that we are approaching the development of a global commercial markets with a disruptive approach to treating anxiety conditions with sequential sub psychedelic dosing of our compounds. Since the majority of patients with anxiety related conditions are cared for by their personal family physician our goal is to create a treatment regimen that is effective and easily a prescribed by patient's personal physician."

該公司董事長兼首席執行官菲利普·J·楊説:“在我們最後一次就L-130的cGMP生產進行溝通之後,我想在我們進入第一階段臨牀試驗時向我們的利益相關者通報我們的最新進展。我們已經獲得監管部門的批准,可以進行我們的第一階段研究,這是對固定劑量的L-130進行安全性和藥代動力學評估的綜合研究。”楊繼續説:“重要的是要記住,我們正在用一種顛覆性的方法來治療焦慮症,這一點很重要。我們正在用一種顛覆性的方法來治療焦慮症,方法是連續亞迷幻劑量的化合物。由於大多數與焦慮症相關的患者都是由他們的私人家庭醫生照顧的,我們的目標是創造一種有效的治療方案,而且很容易由患者的私人醫生開出處方。”

L-130 is regulated as a Schedule 1 substance in the United States and most countries around the world. The Company has received regulatory clearance to import L-130. Initial Phase 1 clinical trials will utilize Clearway Global's network of contract research organizations and we believe that our first subject will enter the first trial in December and topline data will be available for review early in the first quarter of 2023. Data will include safety and pharmacokinetic characteristics of L-130 and psychedelic properties, if any. A second Phase 1 trial is scheduled for the first quarter of 2023 and will accurately assess the therapeutic window for the subsequent Phase 2a trial planned to follow.

在美國和世界上大多數國家,L-130被列為附表1物質。該公司已獲得進口L-130的監管許可。最初的第一階段臨牀試驗將利用Clearway Global的合同研究組織網絡,我們相信我們的第一個受試者將在12月份進入第一次試驗,背線數據將在2023年第一季度初可供審查。數據將包括L-130的安全性和藥代動力學特性以及迷幻特性(如果有)。第二階段1試驗定於2023年第一季度進行,將準確評估隨後計劃進行的2a階段試驗的治療窗口。

As previously announced, the Company has partnered with iNGENu CRO, a contract research organization to finalize and conduct the Phase 2a protocol in Australia. We expect to dose our first patient in our Phase 2 trial in Q2/Q3 2023. We will provide updates as we finalize plans for this important program.

正如之前宣佈的那樣,該公司已經與合同研究機構ingenu CRO合作,在澳大利亞敲定和實施2a階段協議。我們預計在2023年第二季度/第三季度為我們的第二階段試驗中的第一名患者提供劑量。當我們最終確定這一重要計劃的計劃時,我們將提供最新情況。

Maghsoud Dariani, CSO of Lobe Sciences added, "it is important to remember that in just 12 months Lobe has transformed into a fully integrated virtual drug development company. We now have multiple New Chemical Entities' (NCE's) including L-130 that is entering human trials. L-131 is entering pre-clinical trials as we prepare a pediatric Orphan Drug Application with the potential of receiving a Priority Review Voucher for L-131. All of this positions Lobe Sciences among the leaders in the small group of companies who are in clinical development of psychedelic drugs."

洛普科學公司首席技術官馬格蘇德·達裏亞尼補充説:“重要的是要記住,在短短12個月內,洛普公司已經轉變為一家完全集成的虛擬藥物開發公司。我們現在有多個新的化學實體(NCE),包括正在進入人體試驗的L-130。L-131正在進入臨牀前試驗,我們正在準備一項兒科孤兒藥物申請,有可能獲得L-131的優先審查憑證。所有這些都使洛普科學公司成為少數幾家臨牀開發迷幻藥物的公司中的領先者之一。”

About Lobe Sciences Ltd.

關於波爾科學有限公司

Lobe Sciences is a life sciences company focused on practical psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.

Lobe Sciences是一家專注於實用迷幻藥物的生命科學公司。該公司通過與業界領先的合作伙伴合作,致力於使用迷幻化合物進行藥物研究和開發,並開發創新的設備和遞送機制,以改善精神健康和健康。

About Clearway Global, LLC.

關於Clearway Global,LLC

Clearway Global, LLC is a wholly owned subsidiary of Sancilio, LLC, a drug development and research organization with a worldwide network of clinical, formulations, regulatory and production capabilities focused on cost-effective pharmaceutical product development. Clearway Global's focus is to manage the drug development process in a cost-effective and timely manner.

Clearway Global,LLC是Sancilio,LLC的全資子公司,Sancilio是一家藥物開發和研究機構,在世界各地擁有臨牀、配方、監管和生產能力網絡,專注於高成本效益的藥物產品開發。Clearway Global的重點是以具有成本效益和及時的方式管理藥物開發過程。

For further information please contact:

欲瞭解更多信息,請聯繫:

Lobe Sciences Ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623

洛普科學有限公司。
首席執行官菲利普·J·楊
郵箱:Info@lobesciences.com
電話:(949)505-5623

NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.

CSE及其監管服務提供商均未對本新聞稿的準確性或充分性進行審查或承擔責任。

This does not constitute an offer to sell or a solicitation of offers to buy any securities.

這不構成出售要約或邀請買入任何證券的要約。

Forward-Looking Statements

前瞻性陳述

This news release contains forward-looking statements relating to the future operations of the Company 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 news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) 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. Readers are cautioned that assumptions used in the preparation of the forward-looking statements 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, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at . As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. 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 only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.

本新聞稿包含與公司未來業務有關的前瞻性陳述,以及其他非歷史事實的陳述。前瞻性陳述通常用“將”、“可能”、“應該”、“預期”、“預期”和類似的表達方式來識別。除歷史事實陳述外,本新聞稿中包含的所有陳述(包括但不限於有關公司未來計劃和目標、使用迷幻化合物的研究和開發,以及改善精神健康和健康的創新設備和交付機制的開發)均為前瞻性陳述,涉及風險和不確定性。不能保證這樣的陳述將被證明是準確的,實際結果和未來事件可能與此類陳述中預期的大不相同。請讀者注意,在編制前瞻性陳述時使用的假設可能被證明是不正確的。事件或情況可能會導致實際結果與預期大不相同,原因是許多已知和未知的風險、不確定性和其他因素,其中許多是公司無法控制的,包括監管環境的變化;公司的藥物研發活動可能不成功;公司生產的或代表公司生產的藥品和醫療器械可能不以預期的方式或根本不起作用,並可能使公司承擔產品責任或其他責任索賠;公司可能無法實現公司的公司目標和目的;以及在公司不時提交的持續披露文件中詳細説明的其他風險因素,可在公司簡介中查閲,網址為。因此,公司不能保證任何前瞻性陳述都會成為現實,並告誡讀者不要過度依賴任何前瞻性信息。本新聞稿中包含的前瞻性陳述明確地受到本警示性聲明的限制。本新聞稿中包含的前瞻性陳述僅在本新聞稿發佈之日作出,公司不打算更新任何包含的前瞻性陳述,除非適用的加拿大證券法明確要求。

To view the source version of this press release, please visit

要查看本新聞稿的源版本,請訪問

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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