Company: LBRX
Filing Date: 2025-07-23
Form Type: DRS/A
Source: 0000950123-25-006557
Chunk: 175

Company: LB PHARMACEUTICALS INC
Filing Date: 2025-07-23
Form: DRS/A
Chunk 175
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 potentially registrational randomized Phase 2 trial in bipolar depression in
the first quarter of 2026, upon the clearance of an Investigational New Drug, or IND, application for that indication. We are designing this clinical trial to be of registrational quality and if successful, we expect to ask the FDA if this trial
could serve as one of two adequate well-controlled trials needed to obtain approval of LB-102 in bipolar depression. Following a successful Phase 2 trial, we may also consider conducting two Phase 3 trials in
bipolar depression, one as a monotherapy and one as an adjunctive therapy in combination with mood stabilizers, a commonly used treatment for bipolar depression.

Based on the extensive third-party research that has been conducted on amisulpride and a non-racemic
form of the drug and our research indicating a comparable or even improved clinical activity and tolerability profile, including with respect to rates of EPS, sedation and gastrointestinal side effects, of
LB-102, we believe there is broad potential for the development of LB-102 for a variety of psychiatric, neurological and mood disorders. We believe the extensive body of
research on amisulpride provides a potential road map for future development opportunities for LB-102, including the potential for development of LB-102 in MDD, negative
symptoms of schizophrenia, bipolar mania, and Alzheimer’s disease psychosis and agitation.

Our Team and History

Our management and leadership are composed of individuals with extensive experience in the discovery, development, and commercialization of
neuropsychiatric therapeutics.

Heather Turner, J.D., our Chief Executive Officer, was previously President and Chief
Executive Officer of Carmot Therapeutics Inc., prior to its acquisition by Roche Pharmaceuticals for $3.1 billion. Anna Eramo, M.D., our Chief Medical Officer, previously led U.S. clinical and medical affairs at Lundbeck A/S, where her primary
responsibilities extended across its U.S. neurology and psychiatric portfolio of products, including brexpiprazole (which is approved in schizophrenia, MDD, and agitation associated with Alzheimer’s disease), vortioxetine (which is approved for
MDD), and Abilify Maintena (an LAI form of aripiprazole that is approved for schizophrenia and bipolar 1). Other members of our team held various positions at Celgene Corporation, Genzyme Corporation, and ImmunoGen, Inc., with experience
working on late-stage development and commercial products.

Our