First-in-human study plans to enroll healthy volunteers and adults with Type 1 or Type 2 diabetes to evaluate PAL-119's safety and tolerability and explore its effects on the body's own insulin production

SAN DIEGO, Nov. 2, 2026 /PRNewswire/ -- Paulex Bio Inc., a biopharmaceutical company focused on rebuilding the body's own insulin-producing capacity, today announced the registration of its Phase 1/2a first-in-human trial of PAL-119, an investigational oral small molecule designed to regenerate and restore the function of insulin-producing pancreatic beta cells. The study (NCT07901595) will evaluate PAL-119 in healthy volunteers and adults with Type 1 or Type 2 diabetes.

Loss and dysfunction of beta cells are central to both forms of diabetes. In Type 1 diabetes, an autoimmune attack destroys these cells. In Type 2 diabetes, declining beta cell function and mass compound the effects of insulin resistance. PAL-119 is designed to regenerate beta cells and restore their ability to produce insulin, potentially providing a disease-modifying therapy that addresses a central biological driver of both Type 1 and Type 2 diabetes.

"Paulex's vision is to make beta cell regeneration a foundation of diabetes treatment and, ultimately, provide a functional cure for Type 1 and Type 2 diabetes," said Miguel Sanjuan, Ph.D., Co-Founder, President and CEO of Paulex Bio. "Unlike current diabetes medicines, which can replace insulin, stimulate insulin secretion or address other aspects of diabetes, PAL-119 is designed to enable the body to rebuild its own insulin-producing capacity by regenerating beta cells and restoring their ability to respond to glucose. We are excited to launch this clinical program investigating PAL-119 as an important first step toward our ambition of introducing a potentially first-of-its-kind oral medicine that restores the body's ability to produce insulin and reduces the daily burden of living with the disease."

PAL-119 builds on research from the Icahn School of Medicine at Mount Sinai demonstrating in pre-clinical studies that adult human beta cells can be stimulated to regenerate. PAL-119 is designed to regenerate beta cells through the inhibition of dual-specificity tyrosine-phosphorylation-regulated kinase 1A (DYRK1A), an enzyme that acts as a natural brake on beta cell replication. Additionally, the oral small molecule has demonstrated the ability to enhance beta cell function by promoting protein kinase A (PKA) signaling, which supports glucose sensing and insulin secretion. These complementary, dual-action mechanisms offer the potential to both regenerate functional beta cells and restore the body's ability to produce insulin in response to glucose.

About the Phase 1/2a Trial

The randomized, multipart study plans to enroll participants at clinical sites in Australia. The Phase 1 portion in healthy volunteers will evaluate single ascending doses in up to six cohorts, multiple ascending doses in up to three cohorts, and the effect of food on PAL-119 exposure. The ascending-dose portions are blinded and placebo-controlled. The food-effect portion uses an open-label crossover design.

The Phase 2a portion includes separate randomized, double-blind, placebo-controlled studies in adults with Type 2 and Type 1 diabetes. Participants with Type 2 diabetes will receive one of two PAL-119 dose levels or placebo; participants with Type 1 diabetes will receive PAL-119 or placebo.

Safety and tolerability are the primary focus. Additional assessments include pharmacokinetics and changes in plasma C-peptide, a marker of endogenous insulin production, as well as serum insulin, fasting glucose and GLP-1 levels. These measures will help explore PAL-119's effects on beta cell regeneration and function and inform further development.

About PAL-119
PAL-119 is an investigational, dual-action oral small molecule designed to regenerate and restore the function of insulin-producing beta cells, with potential applications in Type 1 and Type 2 diabetes. Originating from research at the Icahn School of Medicine at Mount Sinai, PAL-119 is designed to increase beta cell numbers through DYRK1A inhibition and enhance beta cell function through PKA-associated signaling. PAL-119 was engineered with improved target selectivity and substantially reduced brain exposure compared with harmine.

About Paulex Bio
Paulex Bio Inc. is a biopharmaceutical company focused on changing the course of diabetes by addressing the biological cause of the disease. Its lead candidate, PAL-119, is an investigational oral small molecule designed to regenerate and restore the function of insulin-producing beta cells, with potential applications in Type 1 and Type 2 diabetes. Paulex holds exclusive worldwide rights from the Icahn School of Medicine at Mount Sinai to PAL-119 and related compounds, including composition-of-matter patent families. For more information, visit www.paulexbio.com.

Contacts
Tiberend Strategic Advisors, Inc.

Investor Relations
David Irish / Brooke Cooper
231-632-0002 / 862-274-1134
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646-577-8520 / 201-790-3390
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SOURCE Paulex Bio Inc.