Synthetic Cannabinoid Drug Maker Zynerba Plummets 50%
Synthetic Cannabinoid Drug Maker Zynerba Plummets 50%
Zynerba Pharmaceuticals Inc (NASDAQ: ZYNE) shares retreated to their lowest level since early April following a clinical readout from the company.
齊尼爾巴製藥公司 納斯達克股票代碼：ZYNE）在公司進行臨床讀數後，股票回落至 4 月初以來的最低水平。
What Happened: The Devon, Pennsylvania-based pharma that focuses on developing cannabinoid therapies for rare and near-rare neuropsychiatric disorders said its Zygel did not meet the primary and secondary endpoints of a pivotal study dubbed CONNECT-FX that evaluated the safety and efficacy of the pipeline asset in Fragile X syndrome patients.
發生了什麼事： 總部位於賓夕法尼亞州的德文郡製藥公司，專注於開發用於罕見和近乎罕見的神經精神疾病的大麻素療法，其 Zygel 未達到稱為 CONNECT-FX 的樞軸研究的主要和次要終點，該研究評估了脆弱 X 綜合徵患者中管道資產的安全性和有效性。
Fragile X syndrome is a rare genetic developmental disability that is the leading known cause of both inherited intellectual disability and autism spectrum disorder.
脆性 X 綜合症是一種罕見的遺傳性發育障礙，是遺傳性智力障礙和自閉症譜系障礙的主要已知原因。
Zygel did not achieve statistical significance versus placebo in the primary endpoint of improvement in the Social Avoidance subscale of the Aberrant Behavior Checklist, the company said.
該公司表示，Zygel 在異常行為檢查表的社會迴避子量表中改進的主要終點中沒有達到統計意義與安慰劑的意義。
It also did not show statistical significance versus placebo in the three key secondary endpoints, which were the change from baseline to the end of the treatment period in the Irritability subscale score, the Socially Unresponsive/Lethargic subscale score and Improvement in Clinical Global Impression.
它在三個關鍵的次要終點中也沒有顯示出與安慰劑的統計意義，這是從基線到治療期末的變化，在易怒亞量表評分中，社會無響應/致命性亞量表評分和臨床全球印象的改善。
However, the company noted a pre-planned ad hoc analysis of the most severely impacted patients in the trial, as defined by patients having at least 90% methylation of the impacted FMR1 gene, demonstrated that patients receiving Zygel achieved statistical significance in the primary endpoint. This group, according to the company, comprised 80% of the patients enrolled in the study.
然而，該公司指出，該試驗中受影響最嚴重的患者進行了預先計劃的臨時分析，該分析由具有至少 90％ 受影響的 FMR1 基因甲基化的患者所定義，這表明接受 Zygel 的患者在主要終點中具有統計意義。根據該公司的說法，該小組由參加該研究的患者中有 80％ 組成。
What Next: Based on the positive result from the subset analysis, Zynerba said it intends to meet with the FDA regarding a regulatory path forward for Zygel.
下一步是什麼： 根據子集分析的積極結果，Zynerba 表示，它打算就 Zygel 的監管途徑與 FDA 會面。
The stock plummeted 48% to $3.37 per share.
股票下跌 48% 至每股 3.37 美元。
譯文內容由第三人軟體翻譯。