KalVista Pharmaceuticals Presents New Data Showing Effectiveness Of Sebetralstat In Reducing Anxiety During Attacks; Supports Need For Oral On-Demand Option To Treat Attacks Earlier And More Often At The 2024 HAEi Global Angioedema Forum
KalVista Pharmaceuticals Presents New Data Showing Effectiveness Of Sebetralstat In Reducing Anxiety During Attacks; Supports Need For Oral On-Demand Option To Treat Attacks Earlier And More Often At The 2024 HAEi Global Angioedema Forum
–New data show effectiveness of sebetralstat in reducing anxiety during attacks; supports need for oral on-demand option to treat attacks earlier and more often–
新數據顯示賽貝特司他在減少發作期間的焦慮方面的有效性;支持需要口服即時需求選擇以更早更頻繁地治療發作。
–Patient perspectives spotlight the prevalence of anxiety when faced with administering injectable on-demand therapies–
患者觀點突出在面對注射式即時需求療法時焦慮的普遍性。
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), today announced that it presented data showing the effectiveness of sebetralstat in reducing anxiety among people experiencing hereditary angioedema (HAE) attacks at the HAEi Global Angioedema Forum (GAF) taking place in Copenhagen, Denmark, October 4 - 5, 2024. These data were generated in the KONFIDENT phase 3 clinical trial, for which the Company disclosed top line results in February 2024. Sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of HAE attacks in adults and adolescents aged 12 years and older.
KalVista製藥公司(納斯達克:KALV)今天宣佈,它在2024年10月4日至5日在丹麥哥本哈根舉行的HAEi全球血管性水腫論壇(GAF)上展示了賽貝特司他在減少患有遺傳性血管性水腫(HAE)發作的人群中焦慮的有效性的數據。這些數據是在公司於2024年2月披露頂線結果的KONFIDENt第3期臨床試驗中產生的。賽貝特司他是一種新型的、調查性的口服血漿激肽裂解酶抑制劑,用於成人和12歲及以上的青少年治療HAE發作。
KONFIDENT was the first randomized controlled trial to assess the impact of an on-demand treatment on anxiety associated with HAE attacks. This prespecified exploratoryanalysis was presented by Dr. William R. Lumry, AARA Research Center, Dallas, TX, USA and investigated attack-associated anxiety (in the absence of injectable therapy) in the phase 3 KONFIDENT trial and the impact of sebetralstat on anxiety, compared with placebo. Participants self-reported anxiety using a Modified Generalized Anxiety Numeric Rating Scale. Overall, anxiety was reduced among patients treated with sebetralstat 300mg (P=0.004 and P=0.022, respectively) and 600mg (P=0.0008 and P=0.0012) versus placebo. For participants with moderate-to-extreme anxiety, change from baseline at 4 hours was −2.8 (−3.6, −1.9) for each sebetralstat group and −1.3 (−2.2, −0.4) for placebo and at 12 hours was −3.5 (−4.3, −2.6) with sebetralstat 300mg, −4.3 (−5.2, −3.5) with 600mg, and −1.7 (−2.6, −0.8) with placebo. Notably, anxiety reduction was correlated with earlier time to beginning of symptom relief.
KONFIDENt是第一個評估即時治療對HAE發作相關焦慮影響的隨機對照試驗。這項事先指定的探索性分析由威廉·R·蘭裏博士(美國達拉斯AARA研究中心)展示,研究了第3期KONFIDENt試驗中攻擊相關焦慮(在無注射療法的情況下)以及賽貝特司他對焦慮的影響與安慰劑的比較。參與者使用修正廣泛焦慮數值評定表自我報告焦慮。總體而言,在接受賽貝特司他300毫克(P=0.004和P=0.022,分別)和600毫克(P=0.0008和P=0.0012)的患者中,焦慮減少與安慰劑相比。對於具有中度至極端焦慮的參與者,基線4小時時每個賽貝特司他組減少-2.8(-3.6,-1.9),安慰劑組減少-1.3(-2.2,-0.4),基線12小時時賽貝特司他300毫克減少-3.5(-4.3,-2.6),600毫克減少-4.3(-5.2,-3.5),安慰劑減少-1.7(-2.6,-0.8)。值得注意的是,焦慮減少與開始緩解症狀的時間提前相關。