NHP-229 is being developed as a for the purpose of lowering stomach acid, alone, or in combination with other drugs. A target patient population for such products is persons suffering from gastro-esophageal reflux disease (or GERD).
The Company believes NHP-229 has promise as a proprietary, once-daily oral adjunct therapy to proton pump inhibitors, or PPIs, for the treatment of patients with gastro-esophageal reflux disease, or GERD, who experience breakthrough symptoms, including nocturnal reflux, while taking PPIs or who do not have adequate response to PPIs. PPIs are currently the second leading therapeutic class of drugs with $13 billion of sales in 2009 according to IMS Health. Despite this, approximately 40% of PPI patients suffer breakthrough GERD two to four times a week, and 65% of GERD sufferers experience breakthrough at night. Additionally, approximately 20% to 25% of GERD patients taking PPIs do not respond to treatment in the U.S.
Researchers at Yale have demonstrated that the API in NHP-229 exhibits a dose-dependent ability to increase gastric pH and a sustained systemic acid suppression effect when taken up into the parietal cells of the stomach tissue of animals and humans. Additionally, they have shown that the API demonstrates fast action in reducing gastric acid secretion, raising the pH of the stomach in less than 20 to 30 minutes. The Company believes NHP-229 can also potentially be developed for standalone use, for pediatric use, and as adjunct therapy in the treatment of a number of other significant indications, including pediatric GERD, Zollinger-Ellison syndrome, ulcer disease and gastric cancer. Development is expected to begin in 2014.