Uncategorized Monday, 2024/06/03
Biohaven has released Phase I data for its IgG degrading agent BHV-1300 and stated that BHV-1300 rapidly and selectively reduces IgG in a dose-dependent manner.
BHV-1300 is a bispecific protein degrading agent under research, and its mechanism of action is to search for and bind with pathogenic IgG, bringing it to the liver for degradation. This gives BHV-1300 the potential to treat antibody-driven diseases such as rheumatoid arthritis, myasthenia gravis, and systemic lupus erythematosus.
Preliminary Phase I data shows that some patients have IgG concentrations as low as 50% to 70% of baseline. It is worth noting that previous preclinical studies have shown that multiple doses of BHV-1300 in non-human primates can achieve an IgG reduction of over 90%.
Biohaven also detected that levels of albumin, cholesterol, low-density lipoprotein, liver function indicators, vital signs, or electrocardiogram results had no significant impact. Most side effects are mild or considered unrelated to the investigational drug. No serious adverse reactions occurred.
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Given these early data, Bruce Car, Chief Strategy Officer of Biohaven, described BHV-1300 as “very promising” and stated that the company plans to advance it along with other candidate drugs “through upcoming milestones”. “Our R&D team has made progress in finding new medicinal targets and aims to change the treatment mode by optimizing technology to overturn old therapies. We are very excited about this.”
Analyst William Blair stated that Biohaven's IgG reduction rate is 37%, “lower than the high standard of 60% that we have heard from many investors.” However, Biohaven plans to add two additional groups in its Phase I single-dose escalation (SAD) study, and model data shows that the IgG reduction rate in these groups may exceed 70%.
Biohaven is attempting to potentially compete with Argenx's Vyvgart, efgartigimod, which has been approved for the treatment of myasthenia gravis and is currently being studied for the treatment of other autoimmune diseases.
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