Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 171

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 171
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n=359),
robust statistical analyses, as well as numerous sensitivity analyses. Based on positive end-of-Phase 2 feedback from the FDA, as well as historical precedent, we
believe that our Phase 2 acute schizophrenia trial 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. However, there is no guarantee that our Phase 2 trial may serve as one of the two pivotal trials required for FDA approval, and in such case, we may be required to conduct an additional
pivotal trial in acute schizophrenia. The adequacy of our Phase 2 trial to support registration will be a matter of review by the FDA at the time of NDA submission and will depend on the totality of the data included in our submission, including the
results of our planned Phase 3 trial. 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 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. The sample size will be approximately 400 patients, and 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 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