Synspira Therapeutics today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has granted Orphan Drug Designation to the Company's lead product, SNSP113, a first-in-class glycopolymer, for the treatment of people with cystic fibrosis (CF). SNSP113 was granted Orphan Designation for the treatment of CF by the U.S. Food and Drug Administration (FDA) in October 2018. SNSP113 targets the key drivers of pulmonary decline in cystic fibrosis and other progressive pulmonary diseases, including life-threatening pulmonary infections.

"With orphan designation in both the U.S. and EU, we have achieved an important milestone in our global regulatory strategy and are committed to advancing SNSP113 as a novel approach to treating this debilitating disease," said Robert Gallotto, President and Chief Executive Officer, Synspira Therapeutics. "We believe that SNSP113 has the potential to be the first broad spectrum therapy to improve pulmonary function in patients with CF and look forward to working with the EMA as we progress the program."

Synspira is planning to initiate a study in cystic fibrosis patients with SNSP113 in 2019, a trial that is supported in part by a development award from the Cystic Fibrosis Foundation Therapeutics, Inc.   

The EMA grants Orphan Drug Designation to products that are intended to treat life-threatening or chronically debilitating rare diseases, where prevalence of the condition is less than 5 in 10,000 people in the EU, and where the product has the potential to be of significant benefit. Orphan Designation provides potential incentives, including protocol assistance, reduced EU regulatory fees, potential funding for clinical trials and access to the centralized authorization procedure. If approved in the EU to treat CF, SNSP113 will be eligible for 10 years of market exclusivity, as well as an additional two years of market exclusivity following completion of a pediatric investigation plan (PIP).

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