Biohaven Presents Promising Data for new epilepsy drug BHV-7000 at AES 2023
Pharma |
4 December 2023
In a significant development for epilepsy treatment, Biohaven has announced the presentation of expanded EEG and safety data for its new drug, BHV-7000, at the American Epilepsy Society Annual Meeting. The encouraging Phase 1 results showed safety and tolerability, along with unique EEG spectral power changes that reduce the risk of somnolence.
The Phase 1 study results for BHV-7000 highlight its promising potential in epilepsy treatment. Biohaven reported full Phase 1 results, indicating that BHV-7000, even at doses up to 120 mg daily, was well-tolerated without the usual CNS adverse effects linked to other anti-seizure medications, such as fatigue and cognitive/mood disturbances.
In the Phase 1 electroencephalogram (EEG) biomarker study, BHV-7000 demonstrated dose-dependent target engagement in the brain as measured by changes in EEG spectral power across all brain regions. This suggests that the drug is effectively reaching its target and could potentially have a significant effect on seizure control.
Jason Lerner, M.D., Medical Director and Epilepsy Clinical Lead at Biohaven, commented:
"Selective Kv7 activators are one of the most exciting new drug targets for the treatment of epilepsy, and BHV-7000 has shown a favorable and differentiated profile in preliminary Phase 1 studies to date. We are pleased to see favorable safety and tolerability with BHV-7000 dosed up to 120 mg daily for 15 days, without the CNS adverse effects typically associated with other ASMs, such as somnolence."
BHV-7000 is a potent activator of Kv7.2/Kv7.3, key subunits involved in neuronal signalling and regulating the hyperexcitable state in focal epilepsy. It is chemically and pharmacologically distinct from other Kv7 activators, demonstrates potent anti-seizure effects is well-tolerated in preclinical seizure models, and has shown potential to be a best-in-class Kv7 activator.
The drug was found to be a potent activator of Kv7.2/7.3 channels without significant activation of the GABAA receptor. This unique profile makes BHV-7000 a promising candidate for epilepsy treatment.
Further insights into BHV-7000's mechanism of action were provided in the poster titled "Characterization of BHV-7000: A Novel Kv7.2/7.3 Activator for the Treatment of Seizures."
Impact of BHV-7000
The development of BHV-7000 represents a significant advancement in the treatment of epilepsy. By targeting the Kv7.2/7.3 channels, BHV-7000 has the potential to regulate the hyperexcitable state in focal epilepsy, thereby reducing the frequency and intensity of seizures. The drug has shown a favourable safety and tolerability profile in Phase 1 studies, without the typical CNS adverse effects associated with other ASMs. This could greatly improve the quality of life for people living with epilepsy, a condition that affects around 50 million people worldwide.
About BHV-7000
BHV-7000, the flagship product of Biohaven's Kv7 platform, represents a novel and selective activator of Kv7.2/Kv7.3, pivotal ion channels involved in neuronal signaling and the regulation of hyperexcitability. This innovative compound is under development to address epilepsy and mood disorders. BHV-7000 stands apart from its predecessor, ezogabine (retigabine in Europe), a Kv7 activator approved for adjunctive treatment in adult partial-onset seizures. Notably, BHV-7000 belongs to a distinct structural class, boasting different pharmacology, plasma stability, and resistance to photooxidation compared to ezogabine. Most significantly, BHV-7000 lacks GABAA receptor positive allosteric molecular activity, a trait associated with the limited tolerability of ezogabine. This absence of GABAA receptor activity suggests a broad therapeutic window, potentially resulting in improved efficacy with fewer dose-dependent side effects compared to traditional anti-seizure medications like ezogabine.
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