Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 194

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 194
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LB-102Clinical Data

Completed Phase 1Trial of LB-102in Healthy Volunteers

We conducted a Phase 1, randomized, placebo-controlled, double-blinded clinical trial in the United States to evaluate the safety,
tolerability, and pharmacokinetics of oral administration of LB-102 in 64 healthy volunteers after submitting an IND in October 2019 and receiving approval to proceed in December 2019. In the single ascending
dose, or SAD, portion of this trial, cohorts of six volunteers received doses ranging from 10 mg up to 200 mg. In the multiple ascending dose, or MAD, portion of this trial, cohorts of six volunteers received doses of 50 mg to 100 mg twice-daily for
one week. In total, 48 volunteers were dosed with LB-102. The following chart demonstrates the design of this Phase 1 trial.

Design of the Phase 1 trial of LB-102in healthy volunteers. BID = twice a day.

In September 2020, we announced the clinical results of this Phase 1 trial. The half-life of LB-102 was slightly greater than 12 hours, and maximum drug levels were observed approximately three hours after administration. We observed the plasma exposure of 50 mg of
LB-102 to be 1,648 ng/h/mL. In a previous third-party study of amisulpride, plasma exposure was reported at 667 ng/h/mL. The chart below shows the pharmacokinetic profile of
LB-102 in healthy volunteers from the SAD portion of this trial.

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Pharmacokinetics of LB-102in healthy volunteers.

Analyses of the MAD portion of the trial demonstrated that peak-trough concentrations of LB-102
plateaued before dosing on Day 4. LB-102 accumulated moderately after multiple doses but less than what has been reported for amisulpride. Exposure to LB-102 increased
in a dose-proportional manner.

In this Phase 1 trial, LB-102 was generally well-tolerated. All
treatment emergent adverse effects, or TEAEs, were either mild or moderate. TEAEs included events typically associated with dopamine antagonists. At doses higher than those studied in our Phase 2 trial and which we plan to evaluate in our planned
Phase 3 trial, moderate dystonia and QT prolongation, which is a measure of delayed repolarization of the Q and the T waves in electrocardiogram were observed. Cons