LB Pharmaceuticals Announces the Initiation of Patient Dosing in Open Label Phase 1b Imaging Study of LB-102

NEW YORK--(BUSINESS WIRE)--#LB102--LB Pharmaceuticals Inc, (“LB”) a biotechnology company focused on developing and commercializing novel and improved versions of successful CNS treatments, announced today the administration of the first dose of LB-102 in a Phase 1b clinical trial (Clinical Trials Identifier NCT04588129). This clinical study is designed to evaluate the dopamine receptor occupancy of LB-102 in healthy subjects using positron emission tomography (PET).

LB-102, a more lipophilic version of amisulpride, was designed to improve on amisulpride’s notoriously poor membrane (BBB) permeability while matching amisulpride’s binding affinity to the D₂/D₃ and 5HT₇ receptors (critical to the treatment of schizophrenia). Amisulpride, which is not available in the US, is used for the treatment of schizophrenia and is widely prescribed in over 50 countries, including the EU. Furthermore, amisulpride has been shown to be both effective and well tolerated, as demonstrated by the low all-cause discontinuation rate (a key indicator of patient compliance) compared to 31 other antipsychotics (Huhn et al., 2019).

“The early clinical safety and tolerability profile of LB-102 as seen in last year’s Phase 1 first-in-human study suggests that we are on the right path”, stated Zachary Prensky, President and CEO. “The goal of this Phase 1b study is both to confirm dopamine target engagement and assist in dose selection for our upcoming Phase 2 study in acute schizophrenia patients. We are excited to build on the encouraging clinical data generated to date, and are hopeful to be able to provide doctors and patients with a differentiated and effective treatment option for schizophrenia.”

The American Psychological Association states that less than half of schizophrenia patients treated with current antipsychotics exhibit significant improvements, illustrating the serious unmet medical need that currently exists in the treatment of schizophrenia. With amisulpride unavailable in the US for the treatment of schizophrenia, if approved, LB-102 would become the first benzamide treatment available in the US to treat schizophrenia.

About LB-102

LB-102, or N-methyl amisulpride, is a patented benzamide designed to be an improved version of amisulpride, a dopamine/5-HT₇ antagonist successfully used to treat schizophrenia in Europe for decades. LB-102 was designed to improve on amisulpride’s low permeability across the blood brain barrier. LB-102 has the potential to offer schizophrenia patients the benefits of amisulpride at a lower dose than amisulpride. A first-in-human, double-blind placebo-controlled Phase 1 study designed to test the safety and pharmacokinetics of LB-102 was completed over the summer of 2020.

About LB Pharmaceuticals

LB is a development stage CNS-focused life science 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. 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.

More information about LB-102 and LB Pharmaceuticals may be found on our corporate website located at www.LBPharma.us

Zachary Prensky, President & CEO
Zach@LBPharma.us (212) 605-0230