First Participant Dosed with SNSP113 in CF Trial, Synspira Announces

Synspira has started a Phase 1a clinical trial to determine the safety and tolerability of its cystic fibrosis therapy candidate SNSP113 in healthy volunteers and eventually in patients with stable CF.

The dosing of the first participant marked the trial kick-off, the company announced.

“SNSP113 is the first clinical [trial] 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,” Dr. Shenda Baker, chief executive officer of Synspira, said in a press release.

CF patients experience frequent lung infections. Burkholderia cepacia infections are difficult to eradicate because the bacteria can become resistant to antibiotics. If left untreated, infections and subsequent inflammation can lead to lung damage and loss of lung function.

A study has shown that SNSP113, a polycationic glycopolymer (PAAG), reduces antibiotic resistance by breaking down the outer membrane of bacteria. That gives it the potential to fight CF infections, including ones caused by Burkholderia cepacia. Currently there is no approved treatment for infections with these bacteria.

Researchers published the results of their study in the journal Plos One. The article is titled “Novel glycopolymer sensitizes Burkholderia cepacia complex isolates from cystic fibrosis patients to tobramycin and meropenem.”

“The results published in PLoS One demonstrate that our inhaled glycopolymer drug candidate, PAAG, has the potential to significantly enhance the activity of antibiotics that are used for the treatment of lung infections caused by Burkholderia cepacia complex, a relatively uncommon but often fatal infection in cystic fibrosis,” Baker said when the article appeared.

The Phase 1a trial (NCT03309358) will first assess the safety of inhaled SNSP113 in healthy individuals, and their ability to tolerate it. In 2018, the study is expected to include patients with stable CF.

“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,” Baker said. “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.”

“If effective, this treatment could change the progression of this life-shortening disease and improve the lives of people living with cystic fibrosis,” said Steven M. Rowe, director of the Gregory Fleming James Cystic Fibrosis Research Center at the University of Alabama, Birmingham.