BHV-1600

An investigational subcutaneous autoantibody degrader from Biohaven designed to selectively remove pathogenic beta-1 adrenergic receptor (β1-AR) autoantibodies implicated in peripartum cardiomyopathy (PPCM), a rare, life-threatening form of heart failure that develops during or shortly after pregnancy. BHV-1600 entered Phase 1 in healthy volunteers in late 2024, and in the fourth quarter of 2024 Biohaven held an INTERACT meeting with the FDA and said it gained alignment on a study design that could support accelerated approval in PPCM^[2].

Phase 1 safety data in healthy volunteers have not shown major red flags through single- and multiple-ascending-dose cohorts, with no serious adverse events and no clinically significant changes in immune cells or antibody levels after the first 2 dose groups, per Biohaven^[3]. Because BHV-1600 is selective for β1-AR autoantibodies and does not broadly lower IgG, the infection risk profile is expected to differ from pan-IgG-lowering drugs, but this must be confirmed in patient studies. Safety in pregnant or postpartum women will be studied carefully once patient dosing begins, given the unique clinical setting of PPCM.

Given as a subcutaneous (under-the-skin) injection. Exact dosing and frequency for the patient program have not been disclosed publicly; the Phase 1 healthy-volunteer program used a typical single- and multiple-ascending-dose schedule^[4].

BHV-1600 is currently in phase 1 clinical trials for Peripartum Cardiomyopathy. It has not yet received FDA approval.

BHV-1300 is a broad IgG degrader, it lowers total IgG antibodies, including the thyroid-stimulating antibodies in Graves' disease. BHV-1600 is a TRAP (Targeted Removal of Aberrant Proteins) degrader, it is selective for one specific autoantibody (anti-β1 adrenergic receptor) and leaves the rest of the IgG pool largely intact. That selectivity is why Biohaven chose TRAP for PPCM: the goal is to remove only the pathogenic antibody without suppressing overall immunity in young postpartum women^[3].

Not for several years at the earliest. Biohaven has reported early healthy-volunteer results and says the FDA agreed with a study design that could support accelerated approval, but patient dosing, pivotal trials, and regulatory review are still ahead. Women with PPCM should continue standard heart-failure management with their cardiologist and can ask about clinical-trial referrals as studies open^[5][2].

Yes, many women recover cardiac function with standard heart-failure therapy (beta-blockers, ACE inhibitors/ARBs or ARNI after delivery, diuretics, and anticoagulation when the ejection fraction is very low). However, some women do not fully recover, and there is no therapy that targets the underlying autoimmune attack on the heart. That's the gap BHV-1600 is aimed at^[5].

PPCM is more common in African American women, older mothers and women with high blood pressure in pregnancy^[5]. Despite being rare, it carries high short- and long-term mortality and has no approved disease-specific therapy. A targeted biologic with a clear biomarker (β1-AR autoantibody level) and a defined patient population is the setting where accelerated-approval pathways are designed to reward innovation^[3].