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Cybin | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

Cybin | 6-K:外國發行人報告

美股sec公告 ·  01/23 13:00
牛牛AI助理已提取核心訊息
Cybin Inc., a clinical-stage biopharmaceutical company, has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2a study of CYB004 for the treatment of Generalized Anxiety Disorder (GAD). The study, set to commence in Q1 2024, will be a randomized, double-blind, active-controlled trial to evaluate the clinical efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CYB004 in GAD patients. This follows positive Phase 1 topline safety and efficacy data for CYB004, which showed promising psychedelic effects at lower doses compared to native DMT. Cybin Inc. also announced the grant of a U.S. composition of matter patent for CYB004, with protection expected through 2041. The company's CEO, Doug Drysdale, highlighted the potential of CYB004 to offer improved treatment options for anxiety disorders, which are among the most prevalent mental health disorders globally. Cybin is focused on developing psychedelic-based therapeutics for mental health conditions and has a pipeline of investigational compounds in addition to CYB004.
Cybin Inc., a clinical-stage biopharmaceutical company, has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2a study of CYB004 for the treatment of Generalized Anxiety Disorder (GAD). The study, set to commence in Q1 2024, will be a randomized, double-blind, active-controlled trial to evaluate the clinical efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CYB004 in GAD patients. This follows positive Phase 1 topline safety and efficacy data for CYB004, which showed promising psychedelic effects at lower doses compared to native DMT. Cybin Inc. also announced the grant of a U.S. composition of matter patent for CYB004, with protection expected through 2041. The company's CEO, Doug Drysdale, highlighted the potential of CYB004 to offer improved treatment options for anxiety disorders, which are among the most prevalent mental health disorders globally. Cybin is focused on developing psychedelic-based therapeutics for mental health conditions and has a pipeline of investigational compounds in addition to CYB004.
Cybin Inc. 是一家處於臨床階段的生物製藥公司,已獲得美國食品藥品監督管理局(FDA)的許可,可以繼續進行用於治療廣泛性焦慮症(GAD)的 CYB004 的2a期研究。該研究定於 2024 年第一季度開始,將是一項隨機、雙盲、主動對照試驗,旨在評估 CYB004 在 GAD 患者中的臨床療效、安全性、耐受性、藥代動力學 (PK) 和藥效學 (PD)。在此之前,CYB004 的 1 期安全性和有效性數據呈陽性,與原生 DMT 相比,在較低的劑量下,該數據顯示出令人鼓舞的迷幻效果。Cybin Inc.還宣佈授予 CYB004 的美國物質組合物專利,其保護期預計將持續到2041年。該公司首席執行官道格·德賴斯代爾強調了 CYB004 有可能爲焦慮症提供更好的治療選擇,焦慮症是全球最常見的心理健康障礙之一。Cybin 專注於開發基於迷幻藥的心理健康狀況療法,除了 CYB004 外,還有一系列研究性化合物。
Cybin Inc. 是一家處於臨床階段的生物製藥公司,已獲得美國食品藥品監督管理局(FDA)的許可,可以繼續進行用於治療廣泛性焦慮症(GAD)的 CYB004 的2a期研究。該研究定於 2024 年第一季度開始,將是一項隨機、雙盲、主動對照試驗,旨在評估 CYB004 在 GAD 患者中的臨床療效、安全性、耐受性、藥代動力學 (PK) 和藥效學 (PD)。在此之前,CYB004 的 1 期安全性和有效性數據呈陽性,與原生 DMT 相比,在較低的劑量下,該數據顯示出令人鼓舞的迷幻效果。Cybin Inc.還宣佈授予 CYB004 的美國物質組合物專利,其保護期預計將持續到2041年。該公司首席執行官道格·德賴斯代爾強調了 CYB004 有可能爲焦慮症提供更好的治療選擇,焦慮症是全球最常見的心理健康障礙之一。Cybin 專注於開發基於迷幻藥的心理健康狀況療法,除了 CYB004 外,還有一系列研究性化合物。

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