ISOThrive Inc. announced positive Phase 2 results for MHS-1031 treating NERD patients with incomplete response to proton pump inhibitors (PPIs), demonstrating statistically significant and clinically meaningful reductions in heartburn incidence, severity, and regurgitation. The company’s Chief Medical Officer is presenting these results at Digestive Disease Week (DDW) 2026 this week.
NERD represents approximately 70% of the GERD population, estimated at 45 million adults in the United States, yet remains one of the most challenging segments to treat. Despite advances in acid suppression therapies, including PPIs and newer agents such as potassium-competitive acid blockers (PCABs), a substantial proportion of patients continue to experience persistent symptoms.
“These data highlight the opportunity for a differentiated mechanism that goes beyond acid suppression,” said ISOThrive CEO Jack Oswald. “MHS-1031 has the potential to complement or expand beyond existing treatment paradigms by addressing underlying drivers of symptoms in PPI-refractory patients.”
MHS-1031 is a patented oligosaccharide designed to modulate the esophageal microbiome to reduce inflammatory signaling, representing a shift from acid suppression toward restoring microbiome stasis.
Current therapies, including PPIs and PCABs, are associated with incomplete symptom control in a significant portion of patients, particularly in NERD, where pathophysiology is more complex and less responsive to acid suppression alone.
“These results are particularly compelling because they demonstrate improvement not just in symptom frequency, but in severity and regurgitation, areas where current therapies often fall short,” said Peter Swann, MD, Chief Medical Officer at ISOThrive.
The Phase 2 study is being conducted under an IND with the FDA and includes leading investigators from Vanderbilt University, University of Virginia, and Eastern Virginia Medical School. ISOThrive believes MHS-1031 may represent a novel, differentiated approach to treat this large population with unmet need.