Biopharmaceutical company Synspira Therapeutics reported on Wednesday the receipt of Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) for its lead product SNSP113 for the treatment of people with cystic fibrosis (CF).

CF is a chronic, life-threatening, progressive disease with persistent lung infection, airway blockage due to mucus and biofilm build up and chronic inflammation, thereby limiting the person's ability to breathe over time.

Synspira received the US Food and Drug Administration's (FDA) Orphan Drug Designation for SNSP113 in October 2018.

SNSP113, a first-in-class inhaled glycochemistry-based therapeutic with a broad spectrum mechanism of action, designed to normalize mucin viscosity and improve mucus transport to increase airway clearance. It disrupts the cohesion of bacterial biofilms and interacts with the cell walls of invading bacteria to increase their permeability, reduce their viability and potentiate the efficacy of antibiotics.

Following the EMA's ODD, the company is planning to initiate a study with SNSP113 in cystic fibrosis patients, a trial that is supported in part by a development award from the Cystic Fibrosis Foundation Therapeutics Inc.

Upon approval in the EU to treat CF, SNSP113 will be eligible for ten years of market exclusivity, as well as an additional two years of market exclusivity following completion of a paediatric investigation plan (PIP).