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Novo Nordisk passes single-dose oral insulin Phase I

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Novo Nordisk ($NVO) completed a Phase I single-dose trial of its oral insulin drug, adding Novo to a short list of companies in the running to have the first version of the diabetes pill on the U.S. market.

The Danish company, partnered with Ireland's Merrion Pharmaceuticals, tested the effectiveness and safety of their drug, NN1954, which is designed to be a long-lasting insulin-delivery platform that a patient can take in pill form to treat Type 2 diabetes, according to U.S. regulators.

Oral insulin has been a "holy grail" of sorts among diabetic treatments, both for its potential value as a desirable alternative to frequent injections and also for the difficulty in overcoming its delivery obstacles. As a large protein, unprotected insulin is digested in the gut rather than absorbed as a useful compound, and overcoming this has been problematic.

Merrion's GIPET technology allows the oral version of the drug to work, according to the company's website; by storing the insulin in a specialized molecular package, the technology allows for increased absorption into the bloodstream.

The next step for Novo is to move into a multiple-dose Phase I study, senior vice president of Novo's diabetes research unit Peter Kurtzhals told FierceDrugDelivery. He said it is too early to provide a timeline for entering Phase II, adding that final approval for oral insulin is "approximately 10 years" away.

Other companies are heading down a similar path in getting an oral version of insulin on the market. Last month, Oramed ($ORMP) got closer to Phase II trials, though the FDA required a smaller test before the company moves forward. And India's Biocon hooked up with Bristol-Myers Squibb ($BMY) earlier this year to develop its pill, IN-105.

- here's the clinicaltrials.gov profile
- read more in the Irish Examiner

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