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Biohaven's Epilepsy Treatment Shows Promising Results in P1 Study

Clinical Trials

5 September 2023

Biohaven, a global biopharmaceutical company, has released promising data from a Phase 1 EEG biomarker study of their novel epilepsy treatment. The study, which evaluated EEG spectral power changes in healthy volunteers, confirmed central nervous system activity consistent with other antiseizure drugs. Significant increases in EEG spectral power were observed, particularly at the highest tested dose. 

BHV-7000's safety profile has been praised, with fewer side effects like somnolence, speech disorder, and memory impairment. With positive results from the study and the successful development of a once-daily formula, Biohaven aims to launch Phase 3 trials in focal epilepsy by year-end. According to a release from Biohaven, the EEG study focused on evaluating spectral power shifts after the introduction of BHV-7000 in varying doses (10 mg, 25 mg, or 50 mg) to healthy individuals. 

Notably, EEG spectral power offers a quantitative understanding of rhythmic brain activity within diverse frequency bands. The analyses highlighted that even at the smallest dose of 10 mg, participants with significant BHV-7000 concentrations exhibited considerable increases in specific frequency bands - results that were not replicated in subjects with reduced drug concentrations.

Adding weight to these findings, Dr. Michael Bozik, President of Ion Channel Research & Development at Biohaven, stated, "The EEG biomarker data show effects of BHV-7000 on CNS activity and are incredibly exciting because they further support the paradigm-changing potential of our highly selective Kv7.2/7.3 activator. Together with the preclinical data and the favorable safety and tolerability profile seen in the Phase 1 SAD/MAD studies, the EEG results highlight BHV-7000's potential to deliver robust antiseizure efficacy, without the burdensome CNS adverse effects observed with antiseizure medicines. We are extremely pleased that the BHV-7000 development program continues to advance towards our planned Phase 3 start in the fourth quarter of 2023."

Furthermore, at a 50 mg dose, increased EEG spectral power was observed across all frequency bands. Importantly, BHV-7000 has demonstrated excellent tolerability, with Phase 1 studies indicating a significantly reduced incidence of side effects such as memory impairment, speech disorders, and somnolence. Vlad Coric, MD, the CEO and Chairman of Biohaven, expressed his enthusiasm, confirming the move to pivotal trials by year's end. He emphasized the significance of these EEG findings, combined with safety data and the development of a daily extended-release BHV-7000 formulation.

The EEG results presented are an important milestone after almost a decade of effort by the ion channel discovery team, led by Drs. Michael Bozik and Steven Dworetzky, to develop a highly selective Kv7.2/7.3 activator with a best-in-class drug profile. The EEG data confirms central nervous system target engagement as measured by dose-dependent changes in spectral power in expected frequency bands and over the entire head. We are excited about evaluating the efficacy of this highly selective Kv7.2/7.3 activator in epilepsy, mood disorders (including bipolar disorder) and other diseases as the profile of BHV-7000 represents a potential paradigm shift for this mechanism of action," said Dr. Coric.

About BHV-7000:

BHV-7000 stands out as Biohaven's principal Kv7 asset, specifically designed for treating epilepsy and mood disorders. This distinctive activator of the Kv7.2/Kv7.3 channel, pivotal in neuronal signaling, has been identified for its unique structural and pharmacological properties, distinguishing it from similar medicines like ezogabine. Crucially, the absence of GABAA receptor activity in BHV-7000 might offer a broader therapeutic range, which could lead to enhanced efficacy without the standard side effect profile seen in other antiseizure medications. 

These recent findings were presented during the International Epilepsy Conference 2023 in Dublin, underlining Biohaven's commitment to innovative solutions for rare and common diseases alike. With the commencement of their Phase 3 program in focal epilepsy scheduled before 2023 concludes, the medical world remains keenly attentive to Biohaven's promising developments.

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