July 31, 2017 We have taken many steps this summer to getting Shylicine approved for use in treating microvillus inclusion disease, a rare pediatric disorder that causes chronic diarrhea. Our goal with this oral anti-diarrheal treatment is to restore intestinal function so patients can eat and drink normally.
In June, we received a patent from the European Patent Office for the formulation of Shylicine. During the month of July, we applied for an Orphan designation for Shylicine at the European Medicines Agency (EMA). Currently, the agency’s Committee for Orphan Medicinal Products is reviewing our proposal. The orphan status is assigned to a medicine intended for use against a rare condition. The EMA plays a central role in facilitating the development and authorization of medicines for rare diseases, as well as helps stimulate safe and effective drug development, and makes treatments available more quickly.
You can read more about the Orphan designation on the EMA site here. Our next step is to begin clinical trials for Shylicine in the United States and abroad. We will also be sharing later this summer a new educational website about the disease for patients and doctors. To stay in touch with us about the development of Shylicine, please subscribe to our newsletter by filling out the form in the right column.