Meritage Pharma says it has rounded up some compelling new Phase IIb data on their experimental treatment designed to protect children from a rare and dangerous allergic reaction. In a study of 71 children aged two to 18, the medium or high dose of Meritage's drug reduced the symptoms of eosinophilic esophagitis (EoE)--characterized by a dangerous swelling of the esophagus--by half compared to placebo. And the San Diego-based biotech's CEO says that the data leaves the developer poised on the threshold of a Phase III study.
"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 CEO Elaine Phillips says that the biotech took budesonide, an inhalable immune suppressant, and turned it into a liquid formula that coats the throat. Meritage in-licensed the program from UCSD, where scientists took a slurry of the inhalable formulation and mixed it with Splenda to create a crude but effective elixir to initially demonstrate efficacy. The biotech was launched in 2008 and developed a commercial formulation with the backing of a group of venture companies which provided $30.5 million in funding.
Phillips tells FierceBiotech that Meritage--which has a staff of six--continued to concentrate their work on the pediatric population, where they have gained orphan drug status. But she notes that the entire population includes a large number of adults. About 160,000 patients have been diagnosed with EoE and Phillips adds that the total population in the U.S. has been estimated at 300,000 to 350,000.
The next step is getting a Phase III pediatric trial started early next year. In the meantime, the Meritage team can pursue ongoing partnership talks and consider whether they should strike a deal or raise more funds for the late-stage study. "Clearly we need to secure additional financing if we are to take it forward," says Phillips, who is understandably a little reluctant to lay out a precise timeline needed for a regulatory filing.
- here's the Meritage release