For the millions of Americans who have some level of dairy intolerance, passing on the ice cream and cheese, or carrying supplements to take at the time of consumption, are the only options for avoiding the wrath of an angry gut. But a phase 2 specialty drug firm working on modifying microbiota to treat gastrointestinal disease, including lactose intolerance, is finding success lately with investors and researchers.
Ritter Pharmaceuticals’ platform is based on colonic adaption, or selectively increasing the number of specific beneficial bacteria in the colon to enable lactase digestion. Lactose intolerance, characterized by symptoms including abdominal pain, bloating and gas, is caused by insufficient lactase, an enzyme that lines the small bowel.
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In controlled phase 2 study results released earlier this year, Ritter said that RP-G28 reduced digestive symptoms associated with lactose intolerance by 56 percent in patients (an original announcement about the study said the trial was expected to include 80 subjects with lactose intolerance symptoms).
Founded by Andrew Ritter, the company originally developed a dietary supplement called Lactagen but was (PDF) investigated by the U.S. Food and Drug Administration for its advertising and promotion of the unapproved product as a solution for lactose intolerance. Apparently, the company eventually realized that the big money was in a pharmaceutical and took on the process of running expensive clinical trials and seeking FDA approval, according to a 2011 post in the Hawaii Business magazine blog.
Trials are likely being funded by some of the $6.8 million equity round that the company had been raising since 2010, according to a regulatory filing. The company has picked up $5.8 million total, and an additional six investors since its original filing for the round in 2010, which set the target offering amount at $5 million. An inquiry to the company’s media rep wasn’t returned.
Aside from dairy avoidance, those who are lactose intolerant use lactase supplements to control symptoms. In announcing its trial results, Ritter boasted the trial as the first adequate and well-controlled phase 2 study for a prescription lactose intolerance drug and claimed the RP-G28 has the potential to become the first FDA-approved drug for treating lactose intolerance on a long-term basis by modifying the natural course of the condition.
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Studies have suggested connections between gut flora and a variety of other diseases including obesity and cancer, and have spawned the developments of new diagnostics and drug treatments.