FDA grants Innovate Biopharma's ulcerative colitis drug orphan designation — 3 insights

The FDA awarded Innovate Biopharmaceuticals' INN-108 orphan drug designation.

Here's what you should know:

1. INN-108 is an oral pediatric ulcerative colitis oral therapy. It consists of two moieties, an ulcerative colitis agent and a rheumatoid arthritis agent. The agents are "covalently azo-bonded." They separate in the patient's colon.

2. Innovate Biopharmaceuticals completed two phase I trials for INN-108. Innovate will start a phase II trial in 2018. Innovate is developing a liquid oral formula of INN-108 for pediatric ulcerative colitis patients.

3. If the FDA approves INN-108, Innovate will hold market exclusivity for seven years.

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