Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 166

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 166
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 patients with acute schizophrenia. Results
from the trial demonstrated (i) statistically significant clinical activity at all LB-102 doses tested; (ii) a significant average change in overall symptoms (effect size); (iii) a potentially
class-leading tolerability profile among D/D antagonists; and (iv) a potentially differentiated impact on cognition as measured by
CogState Computerized Schizophrenia Battery of Tests. The trial achieved its primary endpoint of change in the Positive and Negative Syndrome Scale, or PANSS, a 30-item scale that measures the severity of
schizophrenia symptoms, from baseline to Week 4. A statistically significant decrease in symptoms was observed for all three dose cohorts (50 mg, 75 mg, and 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

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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 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 total 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