Company: LBRX
Filing Date: 2025-08-22
Form Type: S-1
Source: 0001193125-25-186467
Chunk: 4

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-08-22
Form: S-1
Chunk 4
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100 mg) compared to placebo. Additionally, our Phase 2 trial data showed a statistically significant impact on negative symptoms versus placebo at the 50 mg dose even though the inclusion criteria enriched for patients experiencing predominantly
positive symptoms of schizophrenia. An exploratory post-hoc analysis of our Phase 2 data on the treatment effect in patients with negative symptoms at baseline (i.e., those patients with a PANSS Negative
Subscore greater than or equal to 24) yielded similar results with a statistically significant impact on negative symptoms versus placebo at the 50 mg dose. LB-102 was generally well tolerated in the clinical
trial, with adverse events being mostly transient and mild to moderate in severity. If replicated in our planned Phase 3 trial, we believe this tolerability profile has the potential to be class-leading among D/D antagonists and partial agonists specifically with respect to the rate of sedation and extrapyramidal symptoms, or EPS, a group of
movement disorders including involuntary movements, muscle stiffness, and tremors, that, together with sedation, are quite burdensome to patients and can result in discontinuation of treatments. The impact of
LB-102 on cognitive function was also evaluated as an exploratory endpoint in this trial. After four weeks of treatment with LB-102, a robust, dose-dependent, and
significant treatment effect size was identified in a post-hoc analysis in the completer population for all doses of LB-102 compared with placebo.

We designed our Phase 2 acute schizophrenia trial to be potentially registrational by including a large sample size (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