Paulex Bio announced a Phase 1/2a first-in-human trial for PAL-119, an oral small molecule designed to regenerate and restore insulin-producing pancreatic beta cells in both Type 1 and Type 2 diabetes.

PAL-119 targets beta cell regeneration by inhibiting DYRK1A and aims to enhance beta cell function through PKA signaling, addressing central biology of both forms of diabetes.

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The trial will enroll healthy volunteers and adults with Type 1 or Type 2 diabetes to assess safety, tolerability, pharmacokinetics, and preliminary effects on endogenous insulin production.

Study NCT07901595 will be conducted at clinical sites in Australia to evaluate safety, tolerability, pharmacokinetics, and early efficacy signals such as endogenous insulin production via C-peptide and glucose-related measures.

Primary endpoints focus on safety and tolerability, with secondary assessments including pharmacokinetics, plasma C-peptide, serum insulin, fasting glucose, and GLP-1 to explore beta cell regeneration and function.

Phase 1 will use single ascending doses across up to six cohorts and multiple ascending doses across up to three cohorts, plus a food-effect assessment, while Phase 2a will be randomized, double-blind, placebo-controlled in Type 2 and Type 1 diabetes.

Phase 1 will be conducted at Australian clinical sites with blinded placebo-controlled cohorts and an open-label crossover for the food-effect portion.

Phase 2a will include separate randomized, double-blind, placebo-controlled studies in Type 2 and Type 1 diabetes, evaluating two PAL-119 dose levels against placebo.

Paulex Bio holds exclusive worldwide rights from the Icahn School of Medicine at Mount Sinai to PAL-119 and related compounds, aiming to develop an oral medicine to restore the body's own insulin production.

PAL-119 originated from Mount Sinai research, designed to increase beta cell numbers and improve glucose-responsive insulin secretion with reduced brain exposure compared with harmine.

The program builds on Mount Sinai research showing adult human beta-cell regeneration and positions PAL-119 as an oral therapy to enable insulin production in response to glucose.