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Presents progress and new anticipated milestones across portfolio of more than 10 assets and 6 therapeutic areas. Announces multiple advancements across the MoDETM (molecular degraders of extracellular proteins) platform and the next generation TRAPTM (targeted removal of aberrant protein) degraders, including: IgA Nephropathy (IgAN) program: First-in-human dosing with BHV-1400, a next generation TRAP degrader, achieved rapid, deep, and selective lowering of only aberrant galactose-deficient IgA1 (Gd-IgA1), the antibody causing IgA nephropathy, while sparing normal IgA.
NEW HAVEN, Conn. , Jan. 7, 2025 /PRNewswire/ -- Biohaven Ltd.
On Monday, Biohaven Ltd. BHVN revealed clinical and regulatory milestones across its proprietary Molecular Degrader of Extracellular Proteins (MoDE) platform and its glutamate modulation and ion channel programs.
BHV-1300 achieved deep lowering of targeted IgG, with reductions > 60% in the lowest subcutaneous dose tested in the MAD. Subcutaneous BHV-1300 achieved rapid and progressive lowering of IgG within hours of each weekly dose administration, and pharmacodynamic effects were sustained relative to baseline over the four-week period.
Reported expanded safety results from BHV-7000 Phase 1 multiple ascending dose studies, including the once-daily extended-release formulation being evaluated in ongoing Phase 2 and 3 clinical studies , demonstrating excellent tolerability at all doses evaluated without central nervous system (CNS) adverse effects typically associated with other anti-seizure medications (ASMs), such as somnolence and cognitive/mood disturbances. Qualitative assessment of online social media platforms and forums provided a unique perspective of the unmet needs that people with epilepsy are vocalizing outside of the clinical setting, including the negative impact that ASM associated adverse events have on their quality of life.
Biohaven's pipeline progression includes Troriluzole for spinocerebellar ataxia [SCA], which has shown a 50-70% reduction in disease progression over three years. BHV-2100, a non-opioid migraine treatment, targets unmet needs in a market affecting 40 million U.S. patients and 1 billion globally. Taldefgrobep Alfa, under investigation for SMA and obesity, demonstrated subgroup-specific motor function improvements and favorable safety in Phase 3 trials.
On Monday, Biohaven Ltd. BHVN updated the taldefgrobep alfa development programs in Spinal Muscular Atrophy (SMA) and obesity.
U.S. stock futures were higher this morning, with the Dow futures gaining more than 300 points on Monday.
Biohaven said on Monday its experimental treatment for spinal muscular atrophy, a rare nervous system dosorder, helped improve patients' motor function in a late-stage study, but failed to achieve statistical significance compared to placebo and standard of care.
In the RESILIENT SMA study, taldefgrobep alpha showed clinically meaningful improvements in motor function at all timepoints on the Motor Function Measurement-32 scale (MFM-32), but the treatment arm did not statistically separate on the primary outcome at Week 48 compared to the placebo+standard of care (SOC) group. Efficacy signals were observed in clinically relevant and biomarker-defined subgroups including those related to age, ambulatory status, background therapy, and baseline myostatin level.