In September 2022, we completed a Phase 1 SAD and MAD study evaluating ANPA-0073, our small molecule product candidate targeting the apelin receptor, or APJR, in which it was generally well tolerated in healthy human volunteers. Beyond GSBR-1290, we are developing next generation GLP-1R candidates, including dual GLP-1R/GIPR agonists, each designed with customized properties to achieve additional benefit. We expect to report topline data for the Phase 1b study and Phase 2a study in the second half of 2023. We initiated the Phase 1b multiple ascending dose, or MAD, study in January 2023 and plan to submit a protocol amendment to the FDA to transition to a Phase 2a proof-of-concept study in T2DM and obesity with expected initiation in the second half of 2023. We submitted an Investigational New Drug application, or IND, to the United States Food and Drug Administration, or FDA, to support initiation of a Phase 1b proof-of-concept study in T2DM and obesity and received FDA allowance in September 2022. GSBR-1290 was generally well tolerated and demonstrated dose-dependent pharmacokinetics, or PK, and pharmacological, or PD, activity. We completed our Phase 1 single ascending dose, or SAD, study of GSBR-1290 in September 2022.
We are developing GSBR-1290, our oral small molecule product candidate targeting the validated glucagon-like-peptide-1 receptor, or GLP-1R, for the treatment of type-2 diabetes mellitus, or T2DM, and obesity. By leveraging our world-class GPCR know-how, we aim to design differentiated small molecule therapies to overcome the limitations of biologics and peptide therapies targeting this family of receptors.
GPCRs regulate numerous diverse physiological and pathological processes, and approximately one in every three marketed medicines targets GPCR-associated pathways. Our initial focus is on G-protein-coupled receptors, or GPCRs, as a therapeutic target class.
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