[Update: 11:30 am] San Diego-based Meritage Pharma set out a few years ago to develop a unique drug for people who suffer from a dangerous allergy that causes swelling and narrowing of the esophagus. Now it has some hard data to suggest that it’s on the right track.
Meritage (pronounced MARE-uh-tazh) is announcing today that its experimental drug for a little-known condition called eosinophilic esophagitis (EoE) passed a mid-stage clinical trial of 71 children ages 2 to 18. The study found that a medium and high dose of the Meritage drug reached the main goal, reducing inflammation and symptoms by half or more, when compared to a placebo. The new drug was well-tolerated, and there were no unexpected adverse events, Meritage said in a statement. Details are being presented today at a medical meeting—Digestive Disease Week in Chicago. [The update includes a reduction in inflammation, which was one of the study goals.]
“The profound reduction of esophageal eosinophilia after treatment with [the Meritage drug] is exciting because, in my experience, patients with reduced eosinophilia will have a better long term prognosis,” said Sandeep Gupta, a professor of clinical pediatrics at Riley Hospital for Children, Indiana University School of Medicine, in a company statement.
Meritage, which I profiled in these pages in December 2008, estimates that about 90,000 children and 110,000 adults in the U.S. are diagnosed with EoE in the U.S. each year. Patients with the condition typically complain of difficulty in swallowing, chest pain, or heartburn-like symptoms. Sometimes patients get misdiagnosed and put on proton-pump inhibitor drugs like omeprazole (Prilosec), which reduce stomach acid with heartburn, Meritage CEO Elaine Phillips has said.
Meritage, which raised its first $22.5 million in March 2008 from Domain Associates, Latterell Venture Partners, and The Vertical Group, has been pursuing a new approach by turning budesonide, an immune-suppressant commonly used as an inhalable asthma drug, into a thick-liquid formula that can be delivered orally, so the medicine where it can be most effective—in the lining of the throat. At the time of the earlier feature, Phillips said the company was making the new formulation “like molasses,” to get the optimal effect.
You can see in Meritage’s statement today how patients responded to the placebo, as well as a low, medium, and high dose of the new drug. About 5.6 percent of patients on the placebo were classified as responders, while about 52.6 percent met that criteria on the medium dose, and 47.1 percent on the high dose did that well. When researchers analyzed cells from the esophagus, they saw that 5.6 percent on the placebo were responders, while the response rate climbed to 52.6 percent for those on the medium dose, and 94.1 percent for those on the high dose.
Phillips, Meritage’s CEO, said her company now has “clear guidance” from the FDA on what it wants to see the company do in the third and final phase of clinical trials to further confirm the results. The company is “eager to advance this therapeutic option to enable EoE patients to thrive, despite their disease,” Phillips said in a statement.
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