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BHV-7000 for Bipolar Disorder Fails in Phase 2/3 Trial
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Key Takeaways
- BHV-7000 failed to achieve statistical significance in a bipolar trial but was safe and well-tolerated, with no serious adverse events.
- Biohaven is pursuing BHV-7000 for major depressive disorder and epilepsy, with results expected in 2025 and 2026.
Pipeline drug BHV-7000 failed to meet primary endpoint in a pivotal phase 2/3 trial for bipolar disorder; meanwhile, BHV-1300 sees success in sustained Reductions in Total IgG.
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Biohaven’s pipeline drug BHV-7000, a selective activator of Kv7.2/7.3 potassium channels, failed to meet the primary endpoint in a pivotal phase 2/3 bipolar trial.1
The phase II/III registrational study (NCT06419582) enrolled 256 participants across 32 sites who were treated with either BHV-7000 or placebo for 21 days. BHV-7000 did not show statistical significance on the primary endpoint of the Young Mania Rating Scale (YMRS), a clinician-administered scale that uses 11 items to assess the patient’s symptoms of mania.
Results show that BHV-7000 75 mg once daily, the highest dose being evaluated, was safe and well-tolerated. There were no treatment-emergent serious adverse events, and most events were mild in intensity and resolved spontaneously.
Despite this setback, Biohaven is currently evaluating BHV-7000 for other disease states, including a phase II trial (NCT06419608) in major depressive disorder (MDD), focal epilepsy, and generalized epilepsy. Topline results from the MDD study are expected in the second half of 2025, and topline data from the focal epilepsy studies (NCT06309966 and NCT06132893) are expected in early 2026. Biohaven has not confirmed whether it plans to continue investigating the drug as a bipolar treatment. Further data will be presented at an upcoming conference.
This news follows yesterday’s announcement from Biohaven regarding their other pipeline candidate, BHV-1300, an IgG degrader. BHV-1300 is designed to selectively target IgG1,2,4 while sparing IgG3, allowing for preservation of key host immune defense against viruses, bacteria, and parasites. In an ongoing phase I study, subcutaneous BHV-1300 achieved 80% reductions in IgG levels within hours of each weekly dose administration, and pharmacodynamic effects were sustained compared with baseline over the 4-week period. Multiple doses achieved up to 84% reduction of total IgG, with a median reduction of 80%, after subcutaneous weekly 1000 mg dosing. There were no clinically significant reductions in other immunoglobulins including IgG3, IgA, IgE, or IgM compared with baseline. Based upon the rapid and deep reductions of total IgG observed with subcutaneous BHV-1300, Biohaven shared its plans to initiate a phase 2 study in Graves' disease in mid-2025, with additional follow-on studies in other autoimmune diseases being pursued.2,3
"Modulation of IgG has proven to be an exciting and growing market in the treatment of autoimmune disease, and BHV-1300 has the potential to further advance the field," said CEO Vlad Coric.2
Dose escalation with BHV-1300 continues in the study and plans to explore deeper reductions to characterize the potential range of targeted IgG lowering possible with Biohaven's MoDE technology, which allows for the customization of speed and depth of IgG lowering and decreased frequency of administration across different disease indications.
Tova Gardin, MD, MPP, chief translational officer at Biohaven, shared, "BHV-1300 has demonstrated remarkable efficacy in deep lowering of total IgG, leveraging the groundbreaking technology of the MoDE platform, to potentially revolutionize treatment of patients with autoimmune disease. Biohaven's unique extracellular degrader technology leverages the body's natural hepatic clearance mechanism to remove targeted antibodies contributing to disease and promises to usher in a new era of tunable, selective and self-administered immune therapy."3
References
1. Beaney A. Biohaven’s pivotal bipolar drug trial fails, stock takes hit. Clinical Trials Arena. March 4, 2025. https://www.clinicaltrialsarena.com/news/biohaven-stock-tumble-bipolar-trial-failure/?cf-view
2. Bratulic A. Biohaven skids after BHV-7000 bipolar study failure. First Word Pharma. March 3, 2025. Accessed March 4, 2025. https://firstwordpharma.com/story/5939341
3. Biohaven reports positive degrader data achieving > 80% sustained reductions in total IgG with potential first-in-class BHV-1300. News release. March 3, 2025. Accessed March 4, 2025. https://firstwordpharma.com/story/5939253
