ISOThrive Inc. announced final results from its Phase 2 trial of MHS-1031 in patients with non-erosive reflux disease (NERD) who experience an incomplete response to proton pump inhibitors (PPIs). Peter Swann, MD, Chief Medical Officer of ISOThrive, and David Johnson, MD MACG FASGE VGSF MACP, Professor of Medicine and Chief of Gastroenterology at Eastern Va Medical School/Old Dominion University, Norfolk VA, and an investigator in the study, are presenting the results at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting today.
MHS-1031 met all primary and secondary efficacy endpoints with clinically meaningful and highly statistically significant reductions in heartburn incidence and severity.
Highly significant improvements in RESQ-eD Regurgitation scores were also observed, reflecting a potential new treatment result not observed with PPIs and PCABs.
“These final results are particularly encouraging because they demonstrate the potential to provide meaningful symptom relief for patients who continue to struggle with heartburn despite PPI treatment,” said Dr. Swann. “The consistency of the findings across heartburn frequency, severity, regurgitation and overall symptom burden, both with a PPI and after PPI withdrawal, provides a strong rationale for advancing the clinical development of MHS-1031.”
“Current acid-suppressive therapies do not adequately control symptoms in a substantial proportion of patients with NERD,” said Dr. Johnson. “These findings support further investigation of the esophageal microbiome as a therapeutic target and highlight the potential value of addressing mechanisms of reflux disease beyond acid suppression.”
Current acid-suppressive therapies leave many patients with NERD experiencing persistent symptoms, even with increased PPI doses or a switch to PCAB therapy. Emerging research suggests that imbalances in the esophageal microbiome may contribute to inflammation and heightened sensitivity to reflux. MHS-1031 is a novel glycan therapeutic designed to modulate the esophageal microbiome, potentially reducing inflammatory signaling associated with persistent heartburn and addressing an underlying disease mechanism not targeted by conventional acid-suppressive therapies.
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