A preclinical study using animal models of cystic fibrosis (CF) showed that SPX-101, a treatment being developed by Spyryx Biosciences, effectively cleared lung mucus in the animals, regardless of the presence of genetic mutations that promote the development of the disease.
Results of this study were presented by John Taylor, Spyryx’s president and CEO, at the recent Jefferies Cystic Fibrosis Summit in New York, a press release reported. He also provided an update on the ongoing Phase 1 clinical trial evaluating the safety of SPX-101.
“Patients with cystic fibrosis have difficulty clearing mucus from their lungs, leaving them prone to frequent chest infections, which leads to progressive and irreversible damage to their lungs,” Taylor said in an interview with Cystic Fibrosis News Today. “SPX-101 represents the first therapeutic opportunity to leverage a natural, biological mechanism that is important to maintenance of normal mucus clearance.”
SPX-101 mimics the function of a protein called SPLUNC-1, which plays an important role in a controlling airway surface hydration and mucus clearance. This mechanism is impaired in CF patients, resulting in the accumulation of mucus and in bacterial lung infections. By replacing SPLUNC1 activity, SPX-101 is designed to successfully restore mucociliary clearance, and remove embedded bacteria and foreign particles from the lungs. The drug’s mechanism of action is independent of the genetic mutations causing CF; for this reason, SPX-101 may become a potential disease-modifying therapy for all CF patients.
“Our product has demonstrated a profound and durable ability to address this clearance issue in both in vitro and in vivo models of CF lung disease, independent of genotypes,” Taylor said. “The inability to clear the lungs of mucus is known to be a key factor that puts all CF patients at risk for the progressive loss of lung function.
“Spyryx is optimistic that SPX-101 has the potential to provide meaningful clinical benefit to all CF patients. Our preclinical pharmacology and safety data, as well as the on-going Phase 1 safety study, are entirely supportive of the initiation of clinical trials with CF patients, which we intend to begin in mid-2017,” he added.
In 2015, the Cystic Fibrosis Foundation awarded a development prize to Spyryx to support the development of SPX-101.