SBS & Obesity
Early programs in collaboration with OPKO
Short Bowel Syndrome
Short bowel syndrome is a complex disease that occurs due to the physical loss or the loss of function of a portion of the small and/or large intestine. Consequently, individuals with short bowel syndrome often have a reduced ability to absorb nutrients such as fats, carbohydrates (sugars) vitamins, minerals, trace elements and fluids (malabsorption).
Currently, the only approved SBS treatment, a GLP-2 analog, requires daily subcutaneous injections.
Obesity
According to the Centers for Disease Control and Prevention (CDC), about 73% of U.S. adults ages 20 and older were considered either overweight (31%) or obese (42%).
Oxyntomodulin (OXM) is a naturally occurring peptide hormone found in the colon, with glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity which suppresses appetite and induces weight loss. An injectable pegylated version of OXM has demonstrated significant reductions in weight loss and decreased plasma triglyceride levels in over 430 patients in phase 2/2b studies.
First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity and Metabolic Diseases
• Program is focused on developing the first oral dual agonist GLP-1/glucagon peptide as a potential once-daily treatment for patients with obesity and metabolic disorders combining OPKO’s proprietary long-acting oxyntomodulin analog (OPK-88006) and Entera’s proprietary N-Tab™ platform. In September 2024, Entera and OPKO Health jointly announced topline pharmacokinetic/ pharmacodynamic (PK/PD) results for the oral oxyntomodulin (OXM) tablet program.
• Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability. The high plasma concentrations with prolonged systemic exposure were consistent with the reported half-life for semaglutide (Rybelsus®), the only approved oral GLP-1 analog. Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo
• In March 2025, we entered into a collaboration and license agreement with OPKO relating to the preclinical and clinical development of the Oral OXM program. The companies expect to file an IND with FDA late in 2025/ early 2026
First GLP-2 Peptide Tablets for Short Bowel Syndrome
Given the challenging compliance rates attributed to injectable GLP-2 therapy and heterogeneity of short bowel syndrome (SBS) patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives. OPKO and Entera are determining next steps for this program
