Why Are Aridis Pharmaceuticals Shares Moving Higher Today?
Why Are Aridis Pharmaceuticals Shares Moving Higher Today?
Aridis Pharmaceuticals Inc (NASDAQ:ARDS) shares are gaining after announcing positive European Medicines Agency feedback on its proposed single confirmatory Phase 3 study of investigational monoclonal antibody candidate AR-301.
阿里迪斯製藥公司 納斯達克股票代碼：ARDS）宣佈歐洲藥品管理局對其擬議的研究單克隆抗體候選藥物 AR-301 的單一確認性三期研究給予積極反饋後，股價上漲。
AR-301 is being developed as an adjunctive therapy with standard-of-care (SOC) antibiotics for pneumonia caused by Gram-positive bacteria Staphylococcus aureus (S. aureus) in mechanically ventilated hospitalized patients.
AR-301 正在開發爲一種輔助療法，使用標準護理 (SOC) 抗生素治療革蘭氏陽性細菌引起的肺炎 金黃色葡萄球菌 （金黃色葡萄球菌）在機械通氣的住院患者中。
Key agreements by the EMA were similar to those agreed by the FDA, which include:
EMA的主要協議與FDA商定的協議類似，其中包括：
- Agreement on the design of the single confirmatory Phase 3 superiority study required to support the submission of a marketing application with the primary efficacy endpoint in older adults.
- In the first Phase 3 study, 'AR-301-002', the magnitude of absolute efficacy was higher in older adults, i.e., +34% improvement on Day 21 (p= 0.057) and by +38% on Day 28 (p= 0.025) in older adults versus +11% improvement (p=0.24) in the overall population.
- Agreement to the proposed expansion of the confirmatory Phase 3 study in S. aureus ventilator-associated pneumonia (VAP) patients to include S. aureus pneumonia in ventilated hospital-acquired pneumonia and ventilated community-acquired pneumonia patients.
- Agreement on Clinical Cure of pneumonia on Day 21 as the primary efficacy endpoint, as in the first Phase 3 study 'AR-301-002'.
- 就單一確認性3期優勢研究的設計達成協議，該研究需要支持提交以老年人爲主要療效終點的營銷申請。
- 在第一項3期研究 “AR-301-002” 中，老年人的絕對療效幅度更高，即在第21天改善了34％（p= 0.057），在第28天，老年人的絕對療效提高了+38％（p= 0.025），而總人羣的絕對療效改善了11％（p=0.24）。
- 同意擴大確認性3期研究的提議 金黃色葡萄球菌 包括呼吸機相關性肺炎 (VAP) 患者 金黃色葡萄球菌 通氣式醫院獲得性肺炎和通氣社區獲得性肺炎患者的肺炎。
- 同意在第21天將肺炎的臨床治癒作爲主要療效終點，就像第一項3期研究 “AR-301-002” 一樣。
AR-301-003 will be the second and final of two planned Phase 3 superiority studies evaluating the efficacy and safety of AR-301 for adjunctive therapy of pneumonia caused by S. aureus in critically ill hospitalized patients.
AR-301-003 將是計劃中的兩項第 3 期優勢研究中的第二項，也是最後一項，該研究旨在評估 AR-301 對肺炎的輔助治療的療效和安全性 S。 金黃色葡萄球菌 在重症住院患者中。
Approximately 200 clinical sites in 20+ countries are expected to participate in the study.
預計將有來自20多個國家的大約200個臨床研究機構參與這項研究。
Price Action: ARDS shares are up 29.40% at $0.34 during the premarket session on the last check Tuesday.
價格走勢： 週二最後一次支票的盤前交易中，ARDS股價上漲29.40％，至0.34美元。
譯文內容由第三人軟體翻譯。