LB Announces Presentation of Full Results of Dopamine Receptor Occupancy Study of LB-102 at the 2021 ACNP Conference

NEW YORK--(BUSINESS WIRE)--#BrainHealth--LB Pharmaceuticals Inc, (“LB”) a biotechnology company focused on developing and commercializing novel and improved versions of successful CNS treatments, announced today that the full results of a PET study of LB-102 (a N methylated version of the well-known and highly effective antipsychotic amisulpride), its lead compound to treat schizophrenia, have been presented at the 60^th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), held from December 5-8 in San Juan, Puerto Rico.

The presentation, titled “PET clinical study of novel antipsychotic LB-102 demonstrates unexpectedly prolonged dopamine receptor engagement,” described results from a PET study designed to evaluate striatal dopamine receptor occupancy (RO) in healthy human subjects. Under steady state conditions 50 mg LB-102, a dose that was well-tolerated in an earlier n = 64 Phase 1 clinical study, demonstrated 70% dopamine D_2/3 RO (60 to 80% dopamine RO is typically considered ideal in treating schizophrenia). Interestingly, LB-102 target engagement persisted over 24 hours and was uncorrelated with plasma concentration. As a comparison, 400 mg of amisulpride are required to achieve the 70% dopamine RO 50 mg LB-102 afforded.

Zachary Prensky, President and CEO, said, “This important study has generated results beyond our expectations, and we are confident that we have found an effective, well tolerated dose range to be further studied in a Phase 2 clinical trial. A double-blind, placebo-controlled, Phase 2 clinical study of LB-102 in schizophrenia patients is expected to begin in the first half of 2022.”

Dean F. Wong, MD, PhD, a Professor of Radiology at Washington University School of Medicine’s Mallinckrodt Institute of Radiology and the principal investigator of the study remarked, “Our observations with LB-102 showed that multiple doses administered once a day resulted in a level of receptor occupancy that previously has been shown with amisulpride to improve symptoms of schizophrenia. Based on the integration of the PET occupancy with PK analyses, LB -102 may have a longer brain retention and more facile brain penetration than the original amisulpride.” Wong also is a Professor of Psychiatry, of Neurology and of Neurosciences at Washington University.

A copy of the abstract will be available on the Company’s website following the presentation at www.LBPharma.us.

About LB Pharmaceuticals

LB Pharmaceuticals 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 approved in the United States. LB is a research-focused organization dedicated to creating novel intellectual property around improved versions of best-selling drugs.

LB’s lead compound, LB-102, or N-methyl amisulpride, is a patented variant of amisulpride, a dopamine D_2/3/5-HT₇ antagonist successfully used to treat schizophrenia in Europe for decades. 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 clinical of LB-102 study designed to test the safety and pharmacokinetics of LB-102 was completed in 2020, and a second clinical study evaluating dopamine receptor occupancy of LB-102 was completed in 2021. A Phase 2 clinical trial of LB-102 in acute schizophrenia patients is expected to begin in the first half 2022.

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