Luye Pharma drug for CNS disorders gets US FDA nod for trials

Luye Pharma Group Ltd. has secured U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for LY03017, allowing clinical trials to commence in the U.S. This next-generation drug, developed in-house, targets Alzheimer's disease psychosis (ADP), Parkinson's disease psychosis (PDP), and the negative symptoms of schizophrenia (NSS). The FDA has waived the single ascending dose (SAD) trial, permitting LY03017 to proceed directly to the multiple ascending dose (MAD) trial and subsequent clinical phases.

LY03017 is a dual-targeted investigational drug, acting as a 5-HT2R inverse agonist and 5-HT2CR antagonist. The group is developing this innovative drug simultaneously in China and the U.S., where it is currently undergoing a phase I clinical trial in China. This drug is part of Luye Pharma's strategic focus on central nervous system (CNS) diseases.

The need for new therapies is critical, with approximately 45m people worldwide affected by Alzheimer's disease, 25-50% of whom develop psychotic symptoms. Parkinson's disease affects over 8.5m individuals globally, with about 60% experiencing psychosis, and schizophrenia impacts roughly 23m people, with an estimated 60% experiencing NSS. There is currently only one FDA-approved drug for PDP, none for ADP globally, and existing NSS treatments have unsatisfactory efficacy.