Core Insights - LB Pharmaceuticals Inc has appointed James Rawls, Pharm.D., as Senior Vice President of Regulatory Affairs, bringing over 25 years of regulatory leadership experience to the company [1][2] - Dr. Rawls will play a crucial role in advancing LB-102 into Phase 3 clinical trials for schizophrenia and Phase 2 trials for bipolar depression in 2026 [2][3] - LB-102 is a Phase 3-ready oral small molecule, a methylated derivative of amisulpride, which has shown positive results in a Phase 2 trial for acute schizophrenia [3][4] Company Overview - LB Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing novel therapies for schizophrenia, bipolar depression, and other neuropsychiatric diseases [4] - The company aims to make LB-102 the first benzamide antipsychotic drug approved for neuropsychiatric disorders in the United States, potentially becoming a mainstay in psychiatric practice [4] Product Development - LB-102 has demonstrated statistically significant benefits in a Phase 2 trial, with a potentially leading safety profile among D2 antagonists and partial agonists [3] - The product is also being considered for expansion into other conditions such as major depressive disorder, Alzheimer's disease psychosis, and cognitive impairment associated with schizophrenia [3]
LB Pharmaceuticals Appoints James Rawls, Pharm.D., as Senior Vice President of Regulatory Affairs
Globenewswire·2025-10-14 12:30