ISOThrive Inc., a clinical-stage biopharmaceutical company, announced interim results from a Phase 2 study of its lead candidate, ISOT-101, for treatment of Non-Erosive Reflux Disease (NERD). The data showed positive trends in addressing heartburn frequency and symptom severity among proton pump inhibitor (PPI) partial-responders (PR), a patient population with major unmet medical need.
These positive developments highlight the significant market potential of ISOT-101 in the NERD PPI-PR segment, an estimated 15-30 million patients in the U.S alone who are inadequately addressed by current gold standard therapies and a multi-billion-dollar annual company market opportunity.
In light of this clinical and commercial potential, long-time ISOThrive board member and pharmaceutical industry veteran Mike Walther will expand his role as Chief Strategy Officer. Mr. Walther’s 30+ year gastroenterology experience, including the launch of and key leadership roles on blockbuster heartburn medications, Prevacid® and Dexilant®, will be leveraged to accelerate the company’s next stage opportunities, including strategic partnerships and/or M&A.
“This encouraging interim data supports our novel approach and strengthens our development program,” said Jack Oswald, CEO. “Our treatment shows the potential to become a leading solution for millions of NERD patients who remain symptomatic despite current treatment options. We believe this progress positions us for a high-value strategic transaction. Bringing a seasoned executive like Mike Walther on board is a critical step in capitalizing on this momentum.”
Mike Walther, Chief Strategy Officer, added, “The interim data for ISOT-101 is exceptionally encouraging, suggesting a meaningful impact in a patient population that remains symptomatic with current options. Having been involved with two of the most successful PPIs, I am thrilled to now work even more closely with the executive team at this pivotal moment to help realize the immense potential of this product and accelerate our path forward for a non-acid suppressing, first-of-it’s kind microbiome-targeting therapy .”
Study completion scheduled for Q4 2025.
ISOThrive Inc. is developing novel, microbiome-targeted therapeutics for gastrointestinal diseases. Its lead product, ISOT-101, with over 30 global patents, is a first-in-class treatment being evaluated for Non-Erosive Reflux Disease (NERD). ISOThrive.com
Acid Reducing Medications: Omeprazole (Prilosec®: AstraZeneca Procter&Gamble, Zegerid®: Riley), Esomeprazole (Nexium®: AstraZeneca), Lansoprazole (Prevacid®: Takeda), Dexlansoprazole (Dexilant®: Takeda), Pantoprazole (Protonix®: Pfizer), Rabeprazole (Aciphex®: Waylis), Vonoprazan (Voquezna®: Phathom).