NEW HAVEN -
The presentations include results from the BHV-7000 Phase 1 EEG biomarker study and additional BHV-7000 safety and tolerability data from Phase 1 single ascending dose (SAD) / multiple ascending dose (MAD) studies. Additional posters showcase BHV-7000's preclinical data, findings from a systematic literature review on health-related quality of life (HRQoL) in patients with focal epilepsy, and results from a cross-sectional survey assessing functional impairments in patients with KCNQ2-DEE.
In addition, both the systematic literature review and parental survey illustrated the importance of Health-Related Quality of Life issues among patients with focal epilepsy and developmental manifestations of KCNQ2-DEE that are relevant to parents, such as communication, eating abilities, and motor impairments.
Presentation Highlights
Poster 2.510: Novel, Selective Kv7.2/7.3 Potassium Channel Activator, BHV-7000, Demonstrates Dose-Dependent Pharmacodynamic Effects on EEG Parameters in Healthy Adults
In this Phase 1 study, pharmacodynamic activity of BHV-7000 in the brain of healthy adults was demonstrated by dose-dependent increases in EEG spectral power.
Unlike prior reports where EEG effects of a Kv7.2/7.3 activator showed the greatest power increase in the delta frequency band (Biondi et al. 2022), the highest spectral power increases with BHV-7000 were seen in alpha, beta, and gamma frequency bands.
While changes in spectral power were observed across all frequency bands with BHV-7000, the minimal impact on slower frequencies (i.e., delta) is consistent with the low incidence of CNS adverse events, in particular somnolence, seen in the BHV-7000 Phase 1 SAD/MAD studies.
EEG delta activity is associated with somnolence, an undesirable CNS adverse event often seen with other ASMs.
Poster 3.265: A First in Human Phase 1 Study Evaluating the Safety and Tolerability of BHV-7000, a Novel, Selective Kv7.2/7.3 Potassium Channel Activator, in Healthy Adults
BHV-7000 was safe and well-tolerated at single doses up to 100 mg and multiple doses up to 120 mg daily for 15 days
No serious adverse events or severe treatment emergent adverse events were reported
Adverse events typically associated with other ASMs, such as somnolence and cognitive/mood disturbances, were not reported
Poster 2.249: Characterization of BHV-7000: A Novel Kv7.2/7.3 Activator for the Treatment of Seizures
BHV-7000 is a potent activator of Kv7.2/7.3 channels, impacting both deactivation kinetics and voltage dependence of activation
BHV-7000 requires the Kv7.2 W236 residue for channel activity
No significant activation of the GABAA receptor with BHV-7000
BHV-7000 is potent in the maximal electroshock seizure (MES) test without impact on neurobehavior or motor (rotorod) behavior
Poster 1.487: Determinants of Health-Related Quality of Life of Patients with Focal Epilepsy: A Systematic Literature Review
This systematic literature review identified multiple factors associated with lower HRQoL in patients with focal epilepsy
Depression and anxiety were among the most significant and frequent determinants of HRQoL change
Other relevant and frequent determinants of HRQoL change included cognition, ASM adverse events, seizure freedom, and employment
A comprehensive understanding of the modifiable determinants of HRQoL is relevant to patient health and well-being and can inform clinical practice and observational/interventional studies
Poster 2.451: Functional Impairments in Patients with KCNQ2-DEE: Associations Among Key Clinical Features
Data obtained from a cross-sectional survey (2018-2020) of parents of children aged 2 years with KCNQ2-DEE was analyzed
Among individuals with KCNQ2-DEE, there is a hierarchy of impairments wherein communication is the most sensitive domain and is often affected in isolation from others
Gross and fine motor skill impairments tend to be correlated
Hand use impairment is closely correlated with multiple other functional impairments
About BHV-7000
BHV-7000, the lead asset from
About
Forward-looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including 'continue', 'plan', 'will', 'believe', 'may', 'expect', 'anticipate' and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of
Contact:
Email: jennifer.porcelli@biohavenpharma.com
Tel: 201-248-0741
Email: mikebeyer@sambrown.com
Tel: 312-961-2502
(C) 2023 Electronic News Publishing, source