Paulex Bio initiates phase 1/2a clinical trial for diabetes candidate PAL-119
Paulex Bio has registered a phase 1/2a trial to evaluate the safety and efficacy of PAL-119, an oral small molecule aimed at regenerating pancreatic beta cells in diabetic patients.
Biopharmaceutical company Paulex Bio has launched a phase 1/2a clinical trial for its lead candidate, PAL-119, a small molecule therapy designed to restore insulin-producing beta cells. The trial will assess the safety, tolerability, and physiological impact of the drug in healthy volunteers and adults with Type 1 and Type 2 diabetes.
The mechanism of PAL-119 targets DYRK1A inhibition to remove natural barriers to cell replication while simultaneously boosting PKA signaling to support glucose sensing. By addressing the loss of beta cell function, the company aims to move beyond traditional insulin-replacement therapies.
CEO Miguel Sanjuan stated that the clinical program intends to demonstrate that the body's native insulin production can be restored. The trial, conducted at sites in Australia, will track plasma C-peptide levels and other glycemic markers to gauge whether the therapy successfully regenerates functional beta cells.