Phase 2 Proof-Of-Concept Study Evaluating BHV-7000 for Major Depressive Disorder Fails to Meet Primary Endpoint

Biohaven today reported results from a phase 2 proof-of-concept study evaluating BHV-7000 for the treatment of major depressive disorder (MDD): BHV-7000 did not demonstrate a reduction of depressive symptoms as measured by change in the Montgomery Åsberg Depression Rating Scale (MADRS) over 6 weeks compared with placebo, thus failing to meet the primary endpoint.¹

"There is an urgent need for novel therapies for depression that require the exploration of new mechanistic approaches to this common disorder. Although the results of this study do not support the efficacy of BHV-7000 in a broad population of depressed patients, we appreciate the commitment of the patients, investigators, and study teams who have advanced the field assessing new therapeutic approaches and made this important research possible,” said Ahmed Tahseen, MD, the development lead for depression at Biohaven.

However, trends favoring BHV-7000 were observed in some clinically relevant subgroups, including participants with more severe depression at screening and baseline, on primary and secondary outcome measures. As to safety profile, BHV-7000 overall was safe and well-tolerated with adverse events mostly mild and moderate in intensity and largely resolved spontaneously. The only individual adverse events occurring with an incidence above 5% were headache (10.7% and 9.9% in BHV-7000 and placebo, respectively) and nausea (4.2% and 5.6% in BHV-7000 and placebo, respectively). A low incidence of central nervous system adverse events was observed, consistent with BHV-7000's lack of GABA activity and with safety data from previously reported studies. Investigators consider the depression subgroup analyses as hypothesis generating.

Biohaven is conducting additional ongoing analyses and plans to present the results at an upcoming scientific meeting; however, they do not plan to conduct additional psychiatric clinical trials and instead have decided to keep resources focused on key priority areas of immunology, obesity, and epilepsy in 2026.

BHV-7000, a selective activator of Kv7.2/7.3 potassium channels, previously failed a phase 2/3 bipolar mania trial.² 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.³

Biohaven management will present at the annual J.P. Morgan Healthcare Conference in San Francisco in January 2026 and intend to provide extensive updates across the breadth of its clinical programs, notably including (1) clinical data for 2 of its extracellular degrader programs from initial patient experience in the phase 1b expansion cohorts BHV-1400 for IgAN and BHV-1300 for Graves' disease; (2) expectations for their recently initiated phase 2b study with taldefgrobep alfa in obesity; (3) oncology clinical stage assets; and (4) emerging data from its ongoing clinical trial with BHV-7000 in adult focal epilepsy.

References

1. Biohaven provides update from phase 2 proof-of-concept study with BHV-7000 in major depressive disorder. News release. January 2, 2026. https://www.prnewswire.com/news-releases/biohaven-provides-update-from-phase-2-proof-of-concept-study-with-bhv-7000-in-major-depressive-disorder-302649251.html

2. 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/

3. Kuntz L. BHV-7000 for bipolar disorder fails in phase 2/3 trial. Psychiatric Times. March 4, 2025. https://www.psychiatrictimes.com/view/bhv-7000-for-bipolar-disorder-fails-in-phase-2-3-trial