億勝生物科技(01061.HK)：乾眼症的美國藥監局第二階段三期臨試取得正面結果
格隆匯 2 月 24日丨億勝生物科技(01061.HK)發佈公吿，有關Essex Bio-Investment(公司的全資附屬公司)與Mitotech及俄羅斯Mitotech 就用於乾眼症的含SkQ1的滴眼液三期臨牀試驗訂立的共同開發協議。誠如Mitotech所吿知，第二階段三期試驗(“VISTA-2”)取得正面結果，重要的是，臨牀試驗研究在關鍵預定的次要終點指標(中央角膜熒光素染色(“CCFS”))的統計數據重複明顯的正面結果。第一階段三期試驗(“VISTA-1”)及VISTA-2均顯示SkQ1在第28天對CCFS恢復透明(定義為中央角膜零染色)及最佳矯正視力(BCVA)改善有顯着影響(VISTA-1及 VISTA-2的終點均為p<0.05)，為下一個關鍵研究的主要終點提供明確的指導，以便向美國藥監局提交新藥申請(“NDA提交”)，取代VISTA-2名義上的共用主要終點(第56天結膜熒光素染色及眼部不適)。VISTA-2研究亦繼續突出該藥物優秀的安全性，其耐受性在統計學上與人工淚液相似。
公吿表示，VISTA-2是一個多中心、隨機、雙盲、安慰劑對照的臨牀研究，有兩個治療組：BID SkQ1滴眼液和BID安慰劑。610名患者參加美國十多個中心的研究，並接受了為期兩個月的治療。根據Mitotech提供的信息，研究的預定關鍵次要終點指標的一(治療僅28天后的CCFS的基線變化)，在以Schirmer評分較高為特徵的患者亞組中，相對安慰劑組顯示出統計學上顯着改善(p<0.05)。在該患者亞組的VISTA-1及VISTA-2研究中均觀察到該功效信號，從而使合併的兩項研究數據集的p值降至<0.0005。
董事會對試驗結果顯示中央角膜恢復透明感到欣慰，這表明SkQ1具有解決乾眼症氧化應激的潛力，並對根據NDA總體監管要求進行的第三階段三期臨牀試驗(VISTA-3)結果充滿期待， Mitotech目標於2022年至2023年完成NDA提交。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
