First there was categorical dismissal: Gluten allergies are “psychosomatic,” leaky gut syndrome is a made-up diagnosis, and celiac disease is a rare condition you might encounter once or twice in your medical career.
Then, begrudging acknowledgment: Mayo Clinic researchers note that nearly 2 million Americans—and 1% of the Caucasian population-- likely have celiac disease.
And now, the latest phase in mainstream medicine’s long, strange relationship with gluten-triggered disorders: a big pharma gold rush.
Indeed, drug developers have finally caught on to what food marketers recognized 15 years ago: there’s a huge number of people whose chronic digestive problems are –or could be—related to gluten sensitivities, and who are desperate for meaningful solutions
According to a recent New York Times article, several pharma companies are scrambling to be first to market with a drug solution to the celiac equation. All are still in early-stage development, and no actual drugs are expected to emerge until 2018 at best.
Alvine Pharmaceuticals, a small, privately-held drug company based in San Carlos, CA, has been working on a formula known as ALV003 that contains two enzymes that—at least in principle—break down gluten into non-allergenic fractions before it ever reaches the intestines.
AbbVie, a Chicago-based pharma development company with revenues of $18.8 billion in 2013, recently paid $70 million to Alvine for an option on the global rights to ALV003.
Alba Therapeutics, a Baltimore company, has been working on a drug called larazotide acetate that blocks gluten from slipping through the tight junctions between epithelial. In other worlds, it purports to treat one of the key features of that once-imaginary leaky-gut syndrome. Alba was recently acquired by global drug giant, Teva Pharmaceuticals.
The FDA has clearly taken note of the gluten-drug bonanza. Late in March the agency held a day-long workshop entitled Gastroenterology Regulatory Endpoints & the Advancement of Therapeutics (GREAT), focused on scientific issues around establishing and measuring meaningful endpoints in celiac disease, irritable bowel syndrome, and oth related conditions.
Ain’t it funny how a condition can go from “imaginary” and “psychosomatic” to significant and worthy of serious investment, as soon as someone sees a large and lucrative market?