Synspira has begun a Phase 1a first-in-human, multicenter study of SNSP113, its lead drug candidate, in development for use in pulmonary complications of cystic fibrosis (CF). SNSP113 has the potential to improve pulmonary function by reducing the viability of recalcitrant infectious bacteria, reducing inflammation, and facilitating clearance of associated biofilms and mucus.

“SNSP113 is the first clinical candidate from a new class of drugs that have the potential to transform the treatment of pulmonary diseases including cystic fibrosis, chronic obstructive pulmonary disease and pneumonia,” said Shenda Baker, PhD, CEO of Synspira. “By simultaneously reducing infections, inflammation and the build-up of mucus and biofilms associated with cystic fibrosis, we believe SNSP113 could improve outcomes for patients. The initiation of our first clinical trial represents a major milestone for Synspira and a significant step forward toward improving the lives of CF patients.”

The Phase 1a first-in-human trial will assess the safety and tolerability of single ascending doses in healthy individuals and will advance into stable CF patients in 2018.

Pre-clinical studies suggest that SNSP113 has the potential to target significant infections in cystic fibrosis, including those driven by Burkholderia and non-tuberculous Mycobacterium for which there are currently no approved therapeutic treatments. Recurring pulmonary infection and inflammation result in permanent lung damage and can eventually lead to pulmonary failure.

“By targeting biofilms and mucus buildup in the lungs and allowing for the potentiation of antibiotics, SNSP113 has the potential to be effective across a wide range of pulmonary complications in CF patients,” said Dr Steven M Rowe, Director of the Gregory Fleming James Cystic Fibrosis Research Center at the University of Alabama, Birmingham. “If effective, this treatment could change the progression of this life-shortening disease and improve the lives of people living with cystic fibrosis.”