According to Spyryx Biosciences, a Phase 1 study of its SPX-101, an inhaled SPLUNC1-derived peptide that the company is developing for the treatment of cystic fibrosis, showed that the drug was well tolerated, with no reduction in lung function and no dose-limiting adverse effects. Based on those results, the company is planning a Phase 2 study in CF patients.
The Phase 1 study in 64 healthy volunteers also showed low systemic exposure, rapid clearance of the drug, and no evidence of elevated potassium
The company had announced positive data from preclinical studies of SPX-101 in November 2016.
Spyryx Chief Medical Officer Alistair Wheeler commented, “The data from this study validate the safety of SPX-101’s novel mechanism of action; the internalization of epithelial sodium channels with a small, inhaled peptide. We are pleased to confirm the absence of safety or tolerability concerns and the lack of significant systemic exposure following 14-day administration. Given the absence of dose-limiting adverse effects in healthy adults, supported by the excellent non-clinical safety data and the strong scientific rationale for a meaningful effect on pulmonary function, we are eager to move the program into the CF patient population.”
Read the Spyryx Biosciences press release.
