Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 204

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 204
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 in the first quarter of 2026, which, if positive, could potentially support a regulatory pathway along with an additional Phase 3 trial for the treatment of bipolar depression as a
monotherapy. We plan to report topline data for this trial in the first quarter of 2028 and, subject to positive results from that trial, meet with the FDA to discuss trial results at an end-of-Phase 2 meeting thereafter. The Phase 2 trial is designed to be an outpatient, two-arm, double-blinded, placebo-controlled, oral, once-daily fixed-flexible dose
of LB-102 in patients with depressive episodes associated with bipolar 1 disorder, with six-week treatment duration. We plan to enroll 359 patients and conduct this
trial entirely in the United States. Patients will be randomized in a 1:1 ratio to LB-102 or placebo. Across most atypical antipsychotics, bipolar depression doses are usually approximately 50% lower than
schizophrenia doses to keep D receptor occupancy at a level that lowers the potential for EPS yet high enough for antidepressant benefit. This is the dosing model that was used by Vraylar and
Latuda, both of which are approved for schizophrenia and bipolar depression. In contrast, Caplyta, another drug approved for use in both schizophrenia and bipolar depression, utilized the same dose in both indications, in part because of its low
rates of EPS. In selecting doses for our Phase 2 trial, we are blending these two paradigms. We plan to initiate all patients on half the lowest dose used in our acute schizophrenia trial (25 mg). Importantly, we believe that results of our Phase 2
acute schizophrenia trial, which demonstrated <1% EPS and no sedation even at 50 mg, provide us an opportunity to explore that dose in bipolar depression similar to Caplyta, which used a single dose across both indications. All patients
randomized to receive LB-102 will begin treatment at 25 mg for the first three weeks of the trial. At the end of Week 3, if a patient has not improved based on a protocol guided set of specific items in the
Clinical Global Impression-Bipolar Illness, or CGI-BP, scale and the patient is tolerating the drug, the dose of LB-102 will be increased in this patient to 50 mg for
the remaining three weeks of the trial, subject to an allowance for up to one dose reduction for safety reasons. This trial design allows us