LB Pharmaceuticals is a development stage life sciences company devoted to commercializing novel and improved versions of successful CNS treatments used extensively overseas but never developed, approved, or marketed in the United States. We believe that there are a number of ‘gold standard’ CNS therapies with excellent safety and efficacy profiles that, for various financial reasons, have never become FDA approved.
Our approach is to create a research-focused organization dedicated to generating novel intellectual property around improved versions of these former best-selling drugs. We have a low-risk, high-reward drug development business plan: invest in bringing to the US market patented, branded, first-to-market versions of standard-of-care CNS therapies currently in use worldwide.
In a Phase 1 study, (ClinicalTrials# NCT04588129) LB-102 showed higher than expected plasma concentration compared to amisulpride and elicited EPS, a biomarker of > 80% dopamine receptor occupancy (mode of action), at substantially lower than expected doses (ECNP 2020). A PET clinical study in humans is expected to begin dosing in Q4 2020 and a n ~300, double-blind, placebo-controlled, Phase 2 clinical study in schizophrenia patients is planned for mid 2021.
LB-102 LAI. Long acting injectable (LAI) medications offer several advantages, in particular in treatment compliance, for schizophrenia patients and are increasingly favored by psychiatrists. Amisulpride is typically dosed between 400 and 800 mg per day, amounts that are too great to incorporate into a LAI formulation and be effective for more than a week. A consequence of the potentially lower effective dose of LB-102 is that it may be feasible to generate a LAI that would be effective for a month of longer. Work is currently underway to determine the feasibility of a LAI formulation of LB-102.