Key Takeaways
- Biohaven’s bipolar disorder treatment candidate, BHV-7000, failed to show significant improvement in mania symptoms during a phase 2/3 trial.
- The trial, involving 250 participants, reported no meaningful difference in Young Mania Rating Scale scores between the treatment and comparator groups.
- BHV-7000 showed good tolerability with no serious adverse events, while Biohaven is exploring its potential for other conditions, including major depressive disorder and epilepsy.
Trial Results for BHV-7000
Biohaven Pharmaceuticals announced disappointing results for its bipolar disorder candidate BHV-7000, which failed to demonstrate improvement in mania symptoms during a phase 2/3 clinical trial. Specifically designed to selectively activate the Kv7.2/Kv7.3 ion channel, BHV-7000 was tested in a study that included approximately 250 participants suffering from bipolar I disorder. Subjects were randomized to receive either 75 mg of the investigational drug or a comparator once daily over three weeks.
Topline data from the trial revealed no statistically significant difference in the change of total scores on the Young Mania Rating Scale (YMRS) between the treatment and comparator groups. The YMRS consists of 11 items that gauge various symptoms of mania. Though specific data was not disclosed, Biohaven indicated that additional analyses are underway, with plans to present the complete dataset at an upcoming scientific meeting.
The trial found BHV-7000 to be well-tolerated among participants, with no reports of serious treatment-emergent adverse events. Most adverse events were mild and resolved on their own, according to the company’s quarterly earnings release.
Ongoing Studies and Future Plans
Despite the setback, Biohaven continues to investigate BHV-7000 in three additional phase 2/3 studies for major depressive disorder (MDD), focal epilepsy, and generalized epilepsy. Final results for the MDD trial are anticipated in the second half of this year, while findings for focal epilepsy are expected in the first half of next year. The company has also noted that it is exploring the drug’s potential applications for pain disorders.
In a separate announcement on March 3, Biohaven provided updates on its early-stage clinical findings for another candidate, BHV-1300. This subcutaneous small molecule asset demonstrated promising results in a phase 1 study for patients with Graves’ disease, reducing total IgG levels by up to 84% with a weekly dosage of 1000 mg. The four-week study confirmed that BHV-1300 is safe and well-tolerated, and Biohaven plans to initiate a phase 2 trial in this indication by mid-2025, with aspirations to conduct follow-on studies in other autoimmune diseases as well.
BHV-1300 utilizes Biohaven’s innovative extracellular degrader technology that selectively targets IgG1, IgG2, and IgG4 antibodies while sparing IgG3. Chief Translational Officer Tova Gardin emphasized the potential of this technology in providing a new form of flexible, selective, and self-administered immune therapy.
Following the announcement regarding BHV-7000’s trial outcomes, Biohaven’s stock experienced a significant decline, dropping 14% from $36.95 to $32 by the close of the market on Monday.
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