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.
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.
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.
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.
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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.
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.
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.
Biohaven also announced the regulatory acceptance of three INDs and/or CTAs for its next-generation MoDE molecules, which target other immune-mediated diseases.
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.
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.
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.
The analyst maintains an Outperform rating on Biohaven ahead of a potentially catalyst-heavy 2025.
Price Action: BHVN stock is down 5.54% at $39.15 at the last check on Tuesday.
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