Abstract Details

Title Phase 1 Study Evaluating the Safety and Tolerability of BHV-7000, a Novel, Selective Kv7.2/7.3 Potassium Channel Activator, in Healthy Adults

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P8 - Poster Session 8 (5:30 PM-6:30 PM)

Poster/Presentation
Number 1-007

Objective Evaluate the safety and tolerability of single and multiple ascending doses (SAD and MAD) of oral BHV-7000.

Background BHV-7000 is a novel, small molecule, selective activator of Kv7.2/7.3 potassium channels, a clinically validated target in epilepsy. In preclinical studies, BHV-7000 showed minimal GABA_A receptor activation and exhibited potent anti-seizure efficacy in the maximal electroshock seizure (MES) model without negatively impacting neurobehavior or motor function.

Design/Methods This was a single center, double-blind, placebo controlled, sequential SAD/MAD study in healthy adult males/females aged 18-55 years. SAD subjects were randomized 3:1 to BHV-7000 (4, 10, 25, 50, or 100 mg) or placebo. MAD subjects were randomized 3:1 to BHV-7000 (10, 25, or 40 mg) or placebo administered daily for 15 days. Safety evaluations included adverse event (AE) monitoring, clinical laboratory tests, vital signs, ECGs, physical examinations, and Sheehan Suicidality Tracking Scale (S-STS).

Results Thirty-nine SAD subjects and 22 MAD subjects were randomized to BHV-7000 or placebo. The mean age of the SAD and MAD subjects was 40.1 and 40.0 years, respectively. Most subjects were male (SAD: 87%; MAD: 91%) and white (SAD: 95%; MAD: 91%). Adverse events occurring in ≥2 BHV-7000 treated subjects (BHV-7000 vs placebo) were headache [3/29 (10.3%) vs 0/10 (0%)] and abdominal discomfort [2/29 (6.9%) vs 0/10 (0%)] for SAD cohorts; and headache [3/17 (17.6%) vs 1/5 (20%)] and back pain [3/17 (17.6%) vs 0/5 (0%)] for MAD cohorts. There were low rates of CNS-related AEs; no somnolence was reported. The majority of AEs were mild and resolved spontaneously. There were no deaths, serious AEs, severe AEs, or dose-limiting toxicities.

Conclusions BHV-7000 was safe and well tolerated, without the typical AEs associated with other anti-seizure medications. These findings support the continued clinical development of BHV-7000 in
epilepsy.

Authors/Disclosures
Irfan Qureshi, MD (Biohaven Pharmaceuticals) PRESENTER	Dr. Qureshi has received personal compensation for serving as an employee of Biohaven. Dr. Qureshi has stock in Biohaven Pharmaceuticals.
Bharat Awsare (Biohaven)	Bharat Awsare has received personal compensation for serving as an employee of Biohaven. Bharat Awsare has or had stock in Biohaven.
Jason Lerner, MD (Biohaven)	Dr. Lerner has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Dr. Lerner has or had stock in Biohaven Pharmaceuticals.
Eric Ashbrenner	Eric Ashbrenner has received personal compensation for serving as an employee of Biohaven. Eric Ashbrenner has stock in Biohaven. An immediate family member of Eric Ashbrenner has stock in Biohaven.
Heather Sevinsky (Biohaven)	Ms. Sevinsky has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Ms. Sevinsky has stock in Biohaven Pharmaceuticals.
Michael E. Bozik, MD (Biohaven Pharmaceuticals)	Dr. Bozik has received personal compensation for serving as an employee of Biohaven . Dr. Bozik has stock in Biohaven.
Steven Dworetzky (Biohaven)	Dr. Dworetzky has received personal compensation for serving as an employee of Biohaven. Dr. Dworetzky has or had stock in Biohaven.Dr. Dworetzky has received intellectual property interests from a discovery or technology relating to health care.
Lia Donahue (Biohaven)	Lia Donahue has nothing to disclose.
Randall Killingsworth (Biohaven Pharmaceuticals)	Randall Killingsworth has received personal compensation for serving as an employee of Biohaven. Randall Killingsworth has stock in Biohaven.
Bruno Francoeur (Syneos Health)	No disclosure on file

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