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.
周一，Biohaven有限公司（纽交所：BHVN）公布了其专有的细胞外蛋白分解酶（MoDE）平台以及其谷氨酸调节和离子通道项目的临床和监管里程碑。
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）是一种帮助预防感染的蛋白质，是体内最常见的抗体类型。IgG水平升高可能与慢性活动性感染或炎症有关。
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.
皮下给药的BHV-1300在正在进行的多次递增剂量（MAD）研究中，在最低的皮下剂量下实现了目标IgG的深度降低，减少幅度超过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%是基于argenx Inc.（纳斯达克：ARGX）皮下efgartigimod可比数据的最低有效性标准，该药物在第29天显示的IgG总体减少平均为66.4%，但目前没有可用于自动注射器的配方。
Also Read: Biohaven Stock Spikes After Drug Candidate To Treat Rare Neurodegenerative Disease Shows Promise
另请阅读：biohaven股票在治疗罕见神经退行性疾病的药物候选者显示出希望后飙升。
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在每次每周剂量给药后的几小时内实现了IgG的逐步减少，并且在四周的研究期间药效在基线水平上持续存在。
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.
对白蛋白或肝功能没有临床显著影响，也没有观察到胆固醇升高。研究结束时第4周的血浆IgG3水平得以保持，以允许健康的免疫效应功能。
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的递增剂量组正在进行中，以探索BHV-1300所能实现的IgG降低的全区间，以适应未来广泛疾病适应症的需求。
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还宣布对其下一代MoDE分子三个IND和/或CTA的监管接受，这些分子针对其他免疫介导的疾病。
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·布莱尔的分析师表示，实现超过60%的IgG减少是一个重要的竞争优势，并且将IgG降低的特征与其他疗法相提并论。
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·布莱尔仍然质疑整体PK/PD特征，因为数据曲线未包含在本次更新中。这些信息对于理解BHV-1300与其他IgG降低疗法的比较至关重要，并期待在2025年第一季度看到更多数据。
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.
同时，分析师认识到与其他IgG降低疗法相比，这个项目在安全性和便利性方面的潜在好处。此外，将Ypsomed的合作视为MoDE平台的一个积极进展。
The analyst maintains an Outperform rating on Biohaven ahead of a potentially catalyst-heavy 2025.
分析师在潜在催化剂丰富的2025年前对Biohaven保持跑赢大盘的评级。
Price Action: BHVN stock is down 5.54% at $39.15 at the last check on Tuesday.
价格动态：截至周二的最后检查，BHVN股票下跌了5.54%，报39.15美元。
- Comstock Fuels Lands $3 Million Boost To Build Next-Gen Renewable Refinery In Oklahoma: Details
- Comstock Fuels获得300万美元的资金用于在俄克拉荷马州建设下一代可再生炼油厂：详细信息
