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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.
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