NEW YORK–(BUSINESS WIRE)–LB Pharmaceuticals Inc (LB), a biotechnology company focused on developing and commercializing new and improved versions of effective CNS treatments, today announced details of its first Phase 1 clinical trial of LB- 102 (NCT04187560) have been published. The article, titled “A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-102, a Selective Dopamine D2/3/5-HTseven inhibitor” (Biernat et al. 2022), was published online in Psychopharmacology. LB-102 is being developed by LB as a potential treatment for schizophrenia and other psychiatric disorders. A copy of the publication is available on the Company’s website at www.LBpharma.us.
This clinical study recruited 64 healthy volunteers and was the first time that LB-102 was assayed in humans. The study consisted of 8 arms (each of 8 subjects randomized 3:1 LB-102:placebo), 5 single dose arms and 3 multiple dose arms (BID dosing). The primary endpoint of this dose-finding study was safety, with pharmacokinetics as a secondary endpoint. The study demonstrated that LB-102 was safe and well tolerated. The pharmacokinetic properties of LB-102 were amenable to once-daily administration, with a half-life of approximately 13 hours. Plasma concentrations of LB-102 were almost perfectly dose-linear.
Based on these encouraging data, along with data from a subsequent clinical study of dopamine receptor occupancy using positron emission tomography, LB is planning a Phase 2 clinical study of LB- 102 in patients with acute exacerbated schizophrenia. This will be a double-blind, placebo-controlled study of two single daily doses of less than 100 mg of LB-102 versus placebo. The primary endpoint of the study will be the change in PANSS from baseline at 4 weeks.
About LB Pharmaceuticals
LB is a development-stage CNS-focused life sciences company dedicated to bringing to market new and improved versions of effective CNS treatments used overseas but not available in the United States. Main compound of LB, LB-102 (NOT-methyl amisulpride) is a new dopamine/5-HTseven antagonist based on amisulpride, a drug that has been successfully used to treat schizophrenia and other psychiatric disorders in Europe for decades.
More information about LB-102 and LB Pharmaceuticals can be found on our website located at www.LBpharma.us.