Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 167

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 167
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 may serve as one of the two pivotal trials required for approval of a new drug application, or NDA, in the United States. As a result, we believe there is a viable path to approval of LB-102 in the United States for the treatment of schizophrenia with a single, six-week Phase 3 trial alongside other planned
NDA-enabling studies. We are planning to initiate a six-week Phase 3 trial of LB-102 in acute schizophrenia patients in the first
quarter of 2026, which we believe, if positive, could be sufficient to support a regulatory application for approval in the United States along with our completed Phase 2 trial and other planned NDA-enabling
studies. The Phase 3 trial is anticipated to be a three-arm, inpatient, double-blinded, placebo-controlled, oral once-daily dose of LB-102 in patients with
schizophrenia, with a six-week treatment duration. We plan to study the effects of 50 mg LB-102 or 100 mg LB-102 versus placebo
in this trial, and patients will be randomized in a 1:1:1 ratio across the three arms of the trial. The sample size will be approximately 400 patients, and we plan to conduct this trial entirely in the United States. The primary endpoint of the
trial is anticipated to be change from baseline in PANSS at Day 42. We expect to disclose topline data from this Phase 3 trial in the second half of 2027 and, if positive, meet with the FDA in the first quarter of 2028 to discuss the potential for
submission of an NDA.

In addition to our clinical development program in schizophrenia, we plan to leverage our expertise in
neuropsychiatry and the unique mechanism of action of LB-102 to develop our product candidate in other indications, starting with bipolar depression. Most people living with bipolar depression experience
dramatic shifts in mood, energy, and behavior, alternating between manic and depressive states. It is estimated that 2.8%, or approximately seven million Americans, experience bipolar disorder in a year, and approximately 40 million people
live with bipolar disorder worldwide. Our initial Phase 2 trial will explore the utility of LB-102 in controlling the depressive symptoms of the disease. We plan to initiate this potentially registrational
randomized Phase 2 trial in bipolar depression in the first quarter of 2026, with topline data expected in the first quarter of 2028.

We
believe LB