LB Pharmaceuticals Information

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. LB-102. LBs lead asset, LB-102, is a novel (patented) analog of amisulpride, a drug used in Europe for decades to treat schizophrenia and low-grade depression. LB-102 is a (low single digit nM) dopamine D2/3 and a (mid teens nM) 5-HT7 antagonist. By methylating amisulpride weve designed a molecule that possesses the same key receptor binding properties while becoming more lipophilic. In preclinical studies (ECNP 2017 ref) LB-102 was determined to be equivalent to amisulpride in: receptor binding and rodent PK profiles, and equivalent to or better than amisulpride in animal behavioral models of schizophrenia. 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 ...