LB Pharmaceuticals Inc (LB), a biotechnology company focused on developing and commercializing novel and improved versions of successful CNS treatments, announced today that details from 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-HT7 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 enrolled 64 healthy volunteers and was the first time LB-102 had been dosed in humans. The study consisted of 8 arms (each of 8 subjects randomized 3:1 LB-102: placebo), 5 single dose and 3 multiple doses (BID dosing) arms. 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-a-day dosing, with a half-life of ~13 hours. Plasma concentrations of LB-102 were nearly perfectly dose-linear.
Based on these encouraging data, as well as 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 LB-102 versus placebo. The primary endpoint of the study will be change in PANSS from baseline at 4 weeks.
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