Phase 1a study for drug to treat CF regardless of CF Mutation

http://www.businesswire.com/news/home/20171018005403/en/Synspira-Announces-Patient-Dosed-Phase-1a-Study

Synspira Announces First Patient Dosed in Phase 1a Study of SNSP113 in Cystic Fibrosis
— First-in-class drug candidate for treatment of cystic fibrosis regardless of genetic mutation —

Synspira, a privately held company developing a new class of inhaled glycopolymer-based therapeutics for the treatment of pulmonary disease, today announced initiation of a Phase 1a first-in-human, multi-center 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, Ph.D., Chief Executive Officer 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. (clinicaltrials.gov ID#NCT03309358)

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.”

About SNSP113

SNSP113 is a glycopolymer-based therapeutic being developed as an inhaled treatment to improve lung function in patients with cystic fibrosis. As a modified polysaccharide molecule, SNSP113 interacts with structural polymers in protective bacterial biofilms, breaking them apart, and with native glycoproteins in mucus, reducing mucus viscosity and adhesion. SNSP113 also interacts with the cell walls of invading bacteria increasing their permeability, thereby reducing their inherent viability and potentiating the efficacy of antibiotics. SNSP113 is designed to reduce infection and inflammation, the key drivers of pulmonary exacerbations and pulmonary decline in cystic fibrosis patients.

About Synspira

Synspira is developing a new class of inhaled glycopolymer-based therapeutics to reduce pulmonary inflammation and infection, key drivers of pulmonary diseases including cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), and pneumonia. Synspira has an exclusive license from Synedgen to the Glycomics Technology Platform for the development of inhaled therapeutics in pulmonary indications. Synspira is dedicated to developing drugs with new mechanisms of action to target and change the course of pulmonary diseases. www.synspira.com

1 Cystic Fibrosis Foundation. About Cystic Fibrosis. https://www.cff.org/What-is-CF/About-Cystic-Fibrosis/.

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