ISOThrive Begins FDA Drug Approval Path of its Product for GERD
Tuesday, April 23, 2019
ISOThrive LLC, a microbiome-inspired therapeutics development company announced today it has begun the process to achieve FDA drug approval of its patented bacterial microFood™ product for Gastroesophageal Reflux Disease (GERD).
A $14B market opportunity of GERD sufferers could benefit from the ISOThrive treatment. GERD affects at least 30% of the U.S. adult population (80 million). The most commonly prescribed treatment is a class of drugs called Proton Pump Inhibitors (PPIs) such as Omeprazole, Prilosec (P&G), Prevacid, Dexilant (Takeda), Protonix (Pfizer), Nexium (AstraZeneca), Aciphex (Eisai). PPIs have been considered generally safe for short term use, yet long-term chronic use may be linked to serious health consequences. In a recent article published in American Journal of Gastroenterology, 46% of patients surveyed expressed meaningful concern over chronic PPI use and a desire to stop using them. Finding safer new therapies that work via a different mechanism of action is of high importance to satisfy this growing unmet need.
The company has engaged leading esophagologists, Key Opinion Leaders (KOLs), from Vanderbilt, Stanford, Washington University, University of Wisconsin, University of Tennessee, University of Virginia, NYU, and Eastern Virginia Medical School to plan and execute a Proof of Concept Study.
"Excitement and interest have been high since we've made this strategic shift," said Jack Oswald, ISOThrive's CEO, CTO and Co-Founder. "We have a clear path to success for our novel therapeutic: a differentiated microbiome-inspired product with a safe new mechanism of action, and an enormous market of GERD sufferers with unmet needs."
According to a case study recently published in Integrative Medicine, ISOThrive Prebiotic Nectar appears to relieve the symptoms of GERD by attacking the root cause of the disease. In the study, 88% of patients surveyed experienced symptom improvement and 17% experienced complete resolution. Another observational study in 100 patients demonstrated similar results.
The company is currently raising a Series A round of investment. Commitments have already been received from some of Silicon Valley's best-known investors.