Spyryx Biosciences has presented data from preclinical studies of its SPX-101 inhaled SPLUNC1-derived peptide showing that SPX-101 improves mucus clearance and survival in animal models of cystic fibrosis and demonstrated no toxicity. The data were presented in three posters at the North American Cystic Fibrosis Conference.
According to the company, nebulized SPX-101 “operating through a novel mechanism of action that promotes the intracellular internalization of epithelial sodium channels, SPX-101 reestablishes the pathway that naturally controls the concentration of these channels and facilitates appropriate fluid levels on the airway surface to restore mucociliary clearance.”
SPX-101 was also shown to be stable, and 28-day toxicology studies in rats and dogs showed no toxicity or adverse effects for doses of up to 19.6 mg/kg/day.
Spyryx Biosciences President and CEO John Taylor said, “We are excited to share these positive results with the community of researchers and physicians who are all dedicated to finding breakthrough treatments for cystic fibrosis. We believe that SPX-101 represents the first therapeutic opportunity to leverage a natural, biological mechanism that is important to the maintenance of normal mucus clearance, with the potential to provide meaningful clinical benefit to all CF patients, regardless of mutation.”
Chief Medical Officer Alistair Wheeler added, “These studies provide important data demonstrating low toxicity and supporting the proposed clinical doses, with no dose-limiting toxicity in the lung or systemically, and with no significant systemic bioavailability. We believe these non-clinical data, combined with the exciting results from the single-ascending dose portion of our Phase 1 safety study, and the pending data from the multiple-ascending dose portion of the Phase 1, supports our intention to move forward with early entry into the clinic in our Phase 2 clinical development plan.”
Read the Spyryx Biosciences press release.
