Investors sour on Biohaven after protein degrader readout

29 May 2024
firstwordpharma.com
Clinical ResultPhase 1PROTACs
Phase I data for Biohaven's lead IgG protein degrader failed to live up to investor expectations, sending shares plunging more than 12%, despite the company touting the results as "positive." The drug, BHV-1300, is being developed to treat rheumatoid arthritis and possibly other immune-related diseases.
The biotech reported at its R&D event Wednesday that BHV-1300 achieved dose-dependent reductions in IgG levels of 5%, 15%, 30%, and 37% across the first four escalating dose cohorts evaluated in healthy volunteers. While showing the drug's ability to selectively degrade IgG –  "within hours of administration," according to the company – the magnitude of reduction at the highest tested dose fell short of the 70% or greater decreases many investors had hoped it would achieve.
However, some analysts suggested the investor reaction may have been too skittish. "While investors had originally been expecting 70% reductions, we believe based on recent conversations that there has been a greater appreciation that this is a goal for the programme, not for this cut of data at lower doses," commented RBC analyst Leonid Timashev.
Higher doses planned
Biohaven noted that some subjects did experience IgG drops as low as 50% to 70% of baseline. The company plans to evaluate two more higher-dose cohorts, with modeling suggesting these could achieve >70% lowering of IgG at doses compatible with subcutaneous administration.
According to Biohaven's website, preclinical studies with BHV-1300 showed IgG depletion of 75% to 80% with single doses within just two days. After three doses, IgG levels were lowered by over 90%. In contrast, the FcRn inhibitorFcRn inhibitor class, which includes drugs like argenx's Vyvgart (efgartigimod alfa) and Immunovant's candidate IMVT-1402, typically requires 7 to 21 days of dosing to reach IgG reductions in the 60% to 80% range.
"With a more direct mechanism of action, BHV-1300 should lead to faster IgG degradation, supported by this initial data, and may also be more amenable to combination therapy," commented William Blair analyst Tim Lugo. Still, while Biohaven stumbled, argenx and Immunovant saw their stocks gain following the readout, and were up about 4% and 5%, respectively.
Meanwhile, Biohaven said BHV-1300 had a clean safety profile with no serious adverse events, and no significant changes in liver function tests were observed across any of the dose cohorts so far. "Given the promising results of the…study thus far, the [multiple ascending dose] study will proceed in patients with rheumatoid arthritis," it added.
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