Biohaven Ltd. (NYSE: BHVN) announced it has initiated first-in-human dosing for BHV-8100, an oral drug designed to modulate the PKM2 enzyme for treating metabolic and immune disorders affecting the central nervous system and other organs.

The Phase 1 study is evaluating the safety, tolerability and pharmacokinetics of BHV-8100 in healthy participants. Preliminary data from the ongoing trial shows the drug achieves projected therapeutic levels and supports once-daily dosing, according to the company's press release.

BHV-8100 targets pyruvate kinase M2, an enzyme involved in cellular energy production. The drug is designed to cross the blood-brain barrier and restore metabolic function in energy-demanding tissues including the brain and retina.

In testing using Bexorg's BrainEx platform, which uses human donor brains, BHV-8100 demonstrated up to three-fold improvement in glucose utilization. The drug showed greater metabolic improvements in brain tissue from Alzheimer's disease donors compared to normal controls.

The company tested BHV-8100 in preclinical models of Alzheimer's disease and multiple sclerosis, reporting metabolic restoration, reduced inflammation and enhanced remyelination.

"BHV-8100 represents a potential fundamental breakthrough in a new class of medicines with potential therapeutic effects in both systemic and brain disorders that involve metabolic and immune dysfunction," said Dr. Bruce Car, Biohaven's Chief Scientific Officer.

Biohaven is targeting applications for neurodegenerative diseases, retinal disorders and immunological conditions. The company estimates Alzheimer's disease affects over 6.5 million Americans with annual treatment costs exceeding $300 billion in the United States.