Shares of Biohaven (BHVN) fell more than 20% after the market opened Wednesday after the company released interim data from a phase 1 study of its autoimmune drug candidate BHV-1300.
The data showed a dose-dependent and rapid decline in IgG levels within a few hours of administration. No serious adverse events were reported, and most adverse events were mild, unrelated to the study drug, and resolved spontaneously.
No significant changes in liver function tests were observed in any dose cohort.
The study showed that BHV-1300 selectively reduced IgG levels without affecting IgA, IgM or IgE levels. Modeling suggests that additional cohorts in the phase 1 study could achieve greater than 70% reduction in IgG levels using doses suitable for subcutaneous administration.
During its annual Investor Research and Development Day, Biohaven also provided updates on other drugs in its development, including BHV-2100, BHV-8000 and weight-loss candidate taldefgrobep. The company expects to receive topline data from a phase 3 study of its spinal muscular atrophy drug myostatin in the second half of 2024.
“While we expect additional detail on the R&D day, we note that the additional data on IgG degraders we believe supports further development,” RBC Capital Markets analysts commented.
“We will be buyers of weaknesses as we see a review of the program as it transitions to RA and possibly additional upgrades later this year. We continue to see significant value in other programs, especially Kv7, and see many additional catalysts that can create value. “, they added.