Investors Turn Cold on Biohaven After Protein Degrader Results

Biohaven's recent reveal of Phase I clinical trial data for their lead IgG protein degrader, BHV-1300, did not meet investor expectations, leading to a more than 12% drop in the company’s stock value. Despite this, Biohaven emphasized the results as "positive." BHV-1300 is being developed primarily for the treatment of rheumatoid arthritis and potentially other immune-related diseases.

During an R&D event on Wednesday, Biohaven disclosed that BHV-1300 induced dose-dependent reductions in IgG levels—5%, 15%, 30%, and 37%—among the first four escalating dose cohorts of healthy volunteers. While the drug demonstrated selective IgG degradation "within hours of administration," the highest dose’s reduction fell short of the anticipated 70% or greater, a threshold many investors were hoping for.

However, some analysts suggested that the investor response might have been overly cautious. RBC analyst Leonid Timashev noted that while the expectation was for 70% reductions, recent insights indicate that this goal was set for the overall program and not necessarily for the initial data at lower doses.

Biohaven highlighted that certain subjects did experience IgG reductions in the range of 50% to 70% from baseline. The company plans to test two additional higher-dose cohorts, with modeling suggesting these could achieve over 70% IgG reduction with doses suitable for subcutaneous administration.

According to Biohaven’s preclinical studies, single doses of BHV-1300 resulted in 75% to 80% IgG depletion within two days, and over 90% reduction after three doses. This contrasts with the FcRn inhibitor class—drugs like argenx's Vyvgart and Immunovant's IMVT-1402—which typically require 7 to 21 days of dosing to achieve IgG reductions between 60% and 80%.

William Blair analyst Tim Lugo commented that BHV-1300’s direct mechanism of action should result in quicker IgG degradation, supported by the initial data. This rapid action might also make BHV-1300 more suitable for combination therapy. Despite Biohaven's setback, argenx and Immunovant experienced stock increases of around 4% and 5%, respectively, following the release of the data.

Biohaven also reported that BHV-1300 demonstrated a clean safety profile, with no serious adverse events and no significant changes in liver function tests observed across any dose cohorts. The company confirmed that the promising results thus far will allow the multiple ascending dose study to proceed in patients with rheumatoid arthritis.

In summary, while Biohaven’s initial Phase I data for BHV-1300 did not fully meet investor expectations, the company remains optimistic about the drug’s potential. Future studies with higher doses may achieve the desired levels of IgG reduction, and the positive safety profile supports continued development. Investors and analysts alike will be closely watching the upcoming trials to see if BHV-1300 can deliver on its promise.

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