Company: LBRX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001193125-25-268174
Chunk: 3

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-11-06
Form: 10-Q
Item: Item 2
Chunk 3
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 profile and strong intellectual property protection. We believe LB-102’s mechanism of action, data from our recently completed Phase 2 trial of LB-102 in acute schizophrenia, and the legacy of clinical experience with amisulpride support the continued development of LB-102 in schizophrenia and bipolar depression. If successful in treating bipolar depression, we may also develop LB-102 in the treatment of major depressive disorder, or MDD. In the future, we may also develop LB-102 for the treatment of other neuropsychiatric disorders, including schizophrenia with predominantly negative symptoms, Alzheimer’s disease-related agitation and psychosis, manic episodes associated with bipolar disorder, and cognitive impairment associated with schizophrenia, or CIAS. We believe that LB-102, if approved, can become a mainstay of psychiatric practice by offering a potentially attractive alternative to branded and generic therapeutics for the treatment of schizophrenia, bipolar depression, and other neuropsychiatric diseases. 

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 New Drug Application, or 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 acute 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.  To increase the trial’s statistical power, we plan to increase the sample size of the Phase 3 trial from approximately 400 patients to approximately 460 patients. We plan to conduct this trial at approximately 25 sites entirely in the United States. The primary endpoint of the trial is anticipated to be change from baseline in PANSS at Day 42. We continue to expect to report topline data in the second half of 2027 for our Phase 3 acute schizophrenia trial.

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