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Biohaven Licenses Oral, Brain-Penetrant for Immune-Mediated Brain Disorders

Anticipates initiating Phase 1 clinical development in 2023.

By: Anthony Vecchione

Biohaven Ltd., acquired global rights, excluding China regions, for the development of an oral, brain-penetrant, dual inhibitor of Tyrosine Kinase 2 (TYK2) and Janus Kinase 1 (JAK1) for the treatment of brain disorders.

BHV-8000 (previously TLL-041) was licensed from Hangzhou Highlightll Pharmaceutical Co. Ltd. (Highlightll) and Biohaven anticipates advancing the agent into a Phase 1 study in 2023. There is currently no brain penetrant, selective, dual TYK2/JAK1 inhibitors approved for brain disorders.

Highlightll will receive $10 million upfront and $10 million in BHVN equity, development and commercial milestone payments of up to $950 million, and tiered royalty payments. Biohaven and Highlightll will coordinate clinical development across global regions.

Vlad Coric, Chairman and CEO of Biohaven, said: “We have gained tremendous insight into the role of the immune system and critical inflammatory signaling pathways with events that drive the onset, propagation and relentless progression of neurodegenerative diseases. BHV-8000, with its blood-brain barrier penetrant activity and dual profile of TYK2/JAK1 inhibition, offers the potential for a unique and highly attractive therapeutic advancement for the treatment of brain disorders. Dual TYK2/JAK1 inhibition is a novel target combination and potentiates complementary activities that permit a graded degree of therapeutic immunomodulation specific to pathogenic neuroimmune pathways.”

Chris Liang, Chairman and CEO of Highlightll said: “Biohaven’s proven track record in successfully innovating, developing, and commercializing neuroscience therapies makes them an attractive partner to help maximize the potential of BHV-8000. We have delivered what we believe is a best-in-class dual TYK2/JAK1 molecule and the team at Biohaven has the clinical development expertise to explore its utility in brain disorders.”

“The addition of BHV-8000 expands our growing and diverse set of complementary neuro-immunomodulatory therapeutic approaches including selective extracellular degraders (commonly referred to as LYTACs or MoDEs) against IgG, IgA, and antigen-specific targets in development at Biohaven,” said Coric. “We are excited to work with Chris and the team at Highlightll to advance this novel and highly differentiated dual TYK2/JAK1 inhibitor in the treatment of brain disorders.”



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