Intense allergic reactions to things like bee stings or peanuts can be life-threatening because some people can suffocate from massive inflammation in the windpipe. But it’s a little-known fact that the same kind of allergic reaction can also cause swelling and narrowing in the food pipe (aka the esophagus). Sometimes it’s so severe that food gets stuck there and needs to be removed in the emergency room.
If Meritage Pharma has sized up this ailment correctly, it may be able to pave the way for a new drug for a little-known disease called eosinophilic esophagitis (EoE). The San Diego-based biotech company is off to a running start, having raised $22.5 million in a Series A financing in March from Domain Associates, Latterell Venture Partners, and The Vertical Group. I learned more about this disease, and Meritage’s experimental drug to treat it, during a visit with CEO Elaine Phillips at the company’s offices (which happen to be just down the hall from Domain).
Meritage (pronounced MARE-uh-tazh) estimates that about 90,000 children and 110,000 adults in the U.S. are diagnosed with this condition in the U.S. each year. Phillips says they generally 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. There are no FDA-approved medications specifically for EOE. Meritage’s idea is to develop budesonide, an immune-suppressant commonly used as an inhalable asthma drug, into a thick-liquid formula that will deliver the medicine where it can be most effective in the lining of the throat.
“We’re making it like molasses,” Phillips says.
Actually, Phillips explained, the liquid form of the drug won’t stick in the throat quite like molasses. The drug will be made to coat the throat so it can be easily absorbed by the mucus lining of the esophagus.
This program is still in the early stages of development. The drug is scheduled to enter its initial human clinical trial, a placebo-controlled study of 80 children, by the end of this year. Some early work was done at San Diego-based Verus Pharmaceuticals, which spun budesonide off to Meritage back in March. The new company reunites a quartet of executives who previously worked together at Verus. The Meritage team includes chairman Cam Garner, Phillips as CEO, Malcolm Hill as chief scientist, and Adam Simpson as chief business officer.
Carving out a business opportunity from a poorly understood disease is clearly a big challenge for a small company. Since there’s no FDA-approved product, that means no trailblazer has set a precedent with the agency on what goals must be met in a clinical trial to receive clearance. Phillips compared the state of this disease to asthma 20 years ago, when it was under-diagnosed, not very well-understood, and rising in prevalence.
One thing that will help on this journey is that budesonide is well-understood by regulators, Phillips says. The disease is also starting to gain increasing awareness around the country, since the hit ABC television show “Extreme Makeover: Home Edition” arranged to build a home for an Idaho family a year ago with four children who suffer from the disease. A month later, People magazine jumped on the idea with a story it called “The Boy Who Couldn’t Eat.”
Meritage isn’t alone in seeing an opportunity to treat this condition. Malvern, PA-based Ception Therapeutics started a placebo-controlled study in February of reslizumab in 172 patients, according to clinicaltrials.gov.
Meritage hopes to stretch the initial capital it raised a long way, by using contract research organizations, manufacturers, and market research, Phillips says. Data on whether the drug works should be collected by June, which will give the company an idea of how aggressive its next steps should be. Until then, it sounds like Meritage will be managing pretty conservatively.
“This is a virtual company, which the VCs tend to like, especially in this environment,” Phillips says. “We’re not going to build huge infrastructure, but we think we have a really good opportunity.”