"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," said John Taylor, President and CEO of Spyryx Biosciences. "SPX-101 represents the first therapeutic opportunity to leverage a natural, biological mechanism that is important to the maintenance of normal mucus clearance that also has the potential to provide meaningful clinical benefit to all CF patients."
The data that will be presented demonstrate that SPX-101:
- Exhibits the ability to provide robust and durable regulation of airway surface liquid height in human epithelial cells and restoration of tracheal mucus velocity in a large animal model of CF
- Possesses a mechanism of action that is independent of the mutations that cause CF, making it a potentially effective treatment for all CF patients
- Has been seen to be safe and well tolerated in a completed single dose and ongoing multiple dose human study supported by a GLP toxicology package
- Can be manufactured at multi-kilogram scale and demonstrates favorable stability under long-term and accelerated conditions
"The data to be presented at this meeting have supported an early entry into the clinic and we are pleased to have completed the single-dose phase of our Phase 1 study without any dose-limiting adverse effects in the lung and with no evidence of significant systemic bioavailability," said Alistair Wheeler MD, Chief Medical Officer at Spyryx.
SPX-101 is an inhaled peptide therapeutic designed to act as a mimetic of the SPLUNC1 protein's binding domain, responsible for regulating the concentration of epithelial sodium channels on the airway surface. This regulatory pathway is used naturally by the lung to modulate airway fluid volumes and promote mucociliary clearance. SPLUNC1's regulation of sodium channels in patients with CF is dysfunctional due to a structural change in the protein resulting from the low pH environment of the CF lung, which renders SPLUNC1 unable to interact with the sodium channels. This results in hyperabsorption of sodium and subsequently water being drawn away from the airway surface and stalling the natural clearance mechanism that normally mobilizes mucus to remove embedded bacteria and foreign particles from the lung.
SPX-101 replaces SPLUNC1's function and restores this control mechanism, promoting proper hydration of the airway surface and restoration of mucus clearance.
Spyryx received a development award from the Cystic Fibrosis Foundation in 2015 to support the development of SPX-101.
About Spyryx Biosciences
Spyryx Biosciences is a privately held, clinical-stage biopharmaceutical company developing innovative therapeutics to address severe lung diseases. Spyryx's lead clinical candidate, SPX-101, is a novel treatment for cystic fibrosis that is currently completing a Phase 1 safety study. The product has demonstrated a robust ability to restore mucociliary clearance in animal models of the disease and has the potential to improve lung function in cystic fibrosis patients independent of their genotype. The Spyryx leadership team and scientific staff have extensive experience in the development of respiratory medicines and work closely with a broad group of clinical and scientific experts in the pulmonary field. Spyryx is funded by a first tier syndicate of life science investors, including Canaan Partners, 5AM Ventures and Hatteras Venture Partners. Further information regarding Spyryx Biosciences is available at www.spyryxbio.com.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/spyryx-biosciences-to-present-safety-stability--effectiveness-data-for-spx-101-at-the-north-american-cystic-fibrosis-conference-october-27-29-2016-orlando-fl-300350083.html
SOURCE Spyryx Biosciences