LB Announces Publication of Phase 1 Clinical Study of LB-102
20 Jul 2022
Clinical Result
NEW YORK--(BUSINESS WIRE)-- 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.<br>
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.
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 overseas but unavailable in the United States. LB’s lead compound, LB-102 (N-methyl amisulpride) is a novel dopamine/5-HT7 antagonist based on amisulpride, a drug successfully used to treat schizophrenia and other psychiatric disorders in Europe for decades.
More information about LB-102 and LB Pharmaceuticals may be found on our website located at www.LBPharma.us.
<br>
Organizations
Indications
Targets
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.