Biohaven Advances in Immunotherapy: Significant IgG Reduction Achieved With BHV-1300, Gains Analyst Approval
Biohaven Advances in Immunotherapy: Significant IgG Reduction Achieved With BHV-1300, Gains Analyst Approval
On Monday, Biohaven Ltd. (NYSE:BHVN) revealed clinical and regulatory milestones across its proprietary Molecular Degrader of Extracellular Proteins (MoDE) platform and its glutamate modulation and ion channel programs.
週一，Biohaven有限公司（紐交所：BHVN）公佈了其專有的細胞外蛋白分解酶（MoDE）平台以及其穀氨酸調節和離子通道項目的臨床和監管里程碑。
Immunoglobulin G (IgG) is a protein that helps prevent infections and is the most common type of antibody in the body. Elevated IgG levels can be seen in chronic active infection or inflammation.
免疫球蛋白G（IgG）是一種幫助預防感染的蛋白質，是體內最常見的抗體類型。IgG水平升高可能與慢性活動性感染或炎症有關。
Subcutaneously administered BHV-1300 achieved deep lowering of targeted IgG, with reductions >60% in the lowest subcutaneous dose tested in the ongoing multiple ascending dose (MAD) study.
皮下給藥的BHV-1300在正在進行的多次遞增劑量（MAD）研究中，在最低的皮下劑量下實現了目標IgG的深度降低，減少幅度超過60%。
William Blair highlights that greater than 60% was the minimum efficacy bar for IgG reductions based on comparable data from argenx Inc's (NASDAQ:ARGX) subcutaneous efgartigimod, which showed a mean total IgG reduction of 66.4% from baseline at day 29 but is not currently available in an autoinjector formulation.
William Blair指出，IgG降低的60%是基於argenx Inc.（納斯達克：ARGX）皮下efgartigimod可比數據的最低有效性標準，該藥物在第29天顯示的IgG總體減少平均爲66.4%，但目前沒有可用於自動注射器的配方。
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另請閱讀：biohaven股票在治療罕見神經退行性疾病的藥物候選者顯示出希望後飆升。
Subcutaneous BHV-1300 achieved a progressive reduction in IgG within hours of each weekly dose administration in the MAD, and pharmacodynamic effects were sustained relative to baseline over the four-week study period.
在MAD中，皮下BHV-1300在每次每週劑量給藥後的幾小時內實現了IgG的逐步減少，並且在四周的研究期間藥效在基線水平上持續存在。
There were no clinically significant effects on albumin or liver function, and no increases in cholesterol were noted. Plasma IgG3 levels were preserved through the end of study week 4 to allow for healthy immune effector functioning.
對白蛋白或肝功能沒有臨床顯著影響，也沒有觀察到膽固醇升高。研究結束時第4周的血漿IgG3水平得以保持，以允許健康的免疫效應功能。
Escalating dose level cohorts of subcutaneous BHV-1300 are ongoing to explore the full range of IgG reductions possible with BHV-1300 for a wide range of future disease indications.
皮下BHV-1300的遞增劑量組正在進行中，以探索BHV-1300所能實現的IgG降低的全區間，以適應未來廣泛疾病適應症的需求。
Biohaven also announced the regulatory acceptance of three INDs and/or CTAs for its next-generation MoDE molecules, which target other immune-mediated diseases.
Biohaven還宣佈對其下一代MoDE分子三個IND和/或CTA的監管接受，這些分子針對其他免疫介導的疾病。
Achieving >60% IgG reduction checks an important competitive box, says a William Blair analyst, and puts the IgG-lowering profile on par with other therapies.
威廉·布萊爾的分析師表示，實現超過60%的IgG減少是一個重要的競爭優勢，並且將IgG降低的特徵與其他療法相提並論。
William Blair still questions the overall PK/PD profile since the data curves were not included in this update. This information will be key to understanding how BHV-1300 compares to other IgG-lowering therapies, and looks forward to seeing more data in Q1 2025.
威廉·布萊爾仍然質疑整體PK/PD特徵，因爲數據曲線未包含在本次更新中。這些信息對於理解BHV-1300與其他IgG降低療法的比較至關重要，並期待在2025年第一季度看到更多數據。
In the meantime, the analyst recognizes the potential benefits of improved safety and convenience with this program compared to other IgG-lowering therapies. Additionally, views the Ypsomed partnership as a positive step for the broader MoDE platform.
同時，分析師認識到與其他IgG降低療法相比，這個項目在安全性和便利性方面的潛在好處。此外，將Ypsomed的合作視爲MoDE平台的一個積極進展。
The analyst maintains an Outperform rating on Biohaven ahead of a potentially catalyst-heavy 2025.
分析師在潛在催化劑豐富的2025年前對Biohaven保持跑贏大盤的評級。
Price Action: BHVN stock is down 5.54% at $39.15 at the last check on Tuesday.
價格動態：截至週二的最後檢查，BHVN股票下跌了5.54%，報39.15美元。
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譯文內容由第三人軟體翻譯。
