A novel drug, BHV-7000, is currently undergoing clinical trials across more than 100 locations nationwide, offering hope for patients with epileptic seizures who have not responded to conventional medications. The drug is being developed by Biohaven Ltd.
BHV-7000 functions by activating potassium receptors in the brain, modulating seizures through a different mechanism than traditional anti-seizure drugs that target sodium and calcium channels. Dr. Taha Gholipour, a neurologist at the University of California, San Diego, and a local investigator in the trial, explained that this new pathway could be crucial for the 40% of epilepsy patients resistant to existing treatments.
Novel Mechanism of Action
While the potassium channel has been a target of interest in neuroscience, previous attempts to develop effective drugs with minimal side effects have been unsuccessful. BHV-7000 has shown promise in preclinical and early clinical trials, demonstrating both tolerability and potency in controlling seizures.
Phase 1 Trial Results
A Phase 1 trial involving 58 patients, predominantly white men with a median age of 40, indicated that BHV-7000 was generally well-tolerated. The main side effects reported were headaches and abdominal discomfort, which resolved upon discontinuation of the drug.
Phase 2/3 Trial Design
The ongoing Phase 2/3 clinical trial aims to enroll 390 participants diagnosed with focal onset epilepsy. This type of epilepsy originates in a specific area of the brain. Participants, aged 18 to 75, are randomly assigned to receive one of two different dose strengths of BHV-7000 or a placebo.
To be eligible for the trial, participants must have a diagnosis of focal onset epilepsy for at least one year, experience four or more seizures in a 28-day period, and have been unsuccessfully treated with at least two anti-seizure medications. They must also be on a stable dose of one to three anti-seizure treatments.
The trial is designed to determine whether BHV-7000 can decrease the average seizure frequency in this patient population. The results of this trial could represent a significant advancement in the treatment of drug-resistant epilepsy.
