SPX-101, a new compound designed by Spyryx Biosciences, recently passed a Phase 1 study for the treatment of severe lung disease, including cystic fibrosis.
A peptide-based drug, SPX-101 is inhaled to restore failing epithelial ion channels in a patient’s airway, giving way to potential disease-modifying therapy for cystic fibrosis patients.
“The data from this study validate the safety of SPX-101’s novel mechanism of action. We are pleased to confirm the absence of safety or tolerability concerns and the lack of significant systemic exposure following 14-day administration,” Alistair Wheeler, chief medical officer of Spyryx, said. “Given the absence of dose-limiting adverse effects in healthy adults, we are eager to move the program into the cystic fibrosis patient population.”
The Phase 1 study measured safety, tolerability and pharmacokinetics. The drug was administered to 64 patients with none showing adverse effects.
Spyryx is now preparing for a Phase 2 study that will focus on the drug's ability to increase lung function in patients with cystic fibrosis and similar diseases.