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.
Our lead compound is LB-102, a product focused on the multi-billion dollar US antipsychotic market. LB-102 is a proprietary variant of amisulpride, a best selling drug with large European market share indicated for the treatment of schizophrenia.
Amisulpride was approved throughout Europe in the early 1990s and was a commercial success during its time as a branded drug. With all amisulpride patents expired and over a dozen new entrants to the market since then, prescriptions for amisulpride are filled millions of times a year throughout Europe/CIS/PacRim yearly comprising a market share within schizophrenia of 5-10% (depending on the country).
Well-controlled trials stretching back twenty years have documented amisulpride’s effective treatment of the negative symptoms of schizophrenia as well as depressive disorders (click here for a sampling of published studies on amisulpride). More specifically, data stretching back 20+ years shows that amisulpride is one of the most effective antipsychotics in the world with no statistically significant difference in efficacy between amisulpride and the two drugs that currently comprise 40% of the US market (olanzapine and risperidone).
LB Pharma has changed the chemical structure of amisulpride to create a novel asset (with patent protection through 2037) that could improve its efficacy and/or improve safety. In pre-clinical testing to date, results show that LB-102:
Preclinical studies show LB-102 has efficacy equivalent to or better than Amisulpride:
1) Has an oral pharmacokinetic profile in mice and rats that matches amisulpride and is amenable to oral dosing
2) Has a CNS receptor binding profile that matches amisulpride, specifically slightly higher affinity at D2/D3 receptors
3) Has better membrane permeability than amisulpride
4) Are as efficacious or more efficacious than amisulpride in rat models of schizophrenia;
a) Similar NOR (cognitive aspects of schizophrenia) and AIC (positive aspects of schizophrenia) rodent assays,
b) statistically superior in LMA (positive aspects of schizophrenia) assay
5) Has a 14-day toxicity profile in rats that matches amisulpride (MTD of 200 mg/kg/day)
Data presented at 2017 ECNP meeting (European Neuropsychopharmacology, 2017, 27 (S4), S922-S923)
If approved by the FDA, LB-102 would be the first benzamide atypical approved for the US market. We believe a conservative market share of LB-102 upon approval could exceed 2% (or 60,000 patients) with peak yearly revenues exceeding $1B.
We have a number of pre-clinical assets in development targeting additional CNS indications where the US market has an existing, unfilled need for treatments that have already shown proof of efficacy and safety in dozens of countries outside the US. In many cases these compounds are standard-of-care, and US patients suffering without treatment willingly spend tens of thousands of dollars per year importing personal use amounts of drug in an effort to keep their illness at bay. Without an FDA approved product, only the wealthiest of these US patients can afford to self-treat their illness; thousands suffer needlessly. Our goal is to permanently change this unfair situation by providing FDA approved, standard-of-care products that can be reimbursed by insurance and supplied to all patients, regardless of ability to pay.
