Spyryx Biosciences is developing next-generation therapeutics for obstructive lung diseases, with a particular focus on Cystic Fibrosis and COPD. Our commitment goes beyond innovation; we aim to empower patients and their families who bravely face these challenges every day. By leveraging cutting-edge research and technology, we are working to create targeted therapies that not only improve lung function but also enhance overall quality of life. We prioritize patient-centric approaches, ensuring that our solutions are informed by real-world experiences and needs. Together, we strive to make a meaningful difference in the lives of those affected by these diseases, fostering hope and resilience in the fight for better health.

OUR STORY 

Spyryx Biosciences is a biopharmaceutical company developing novel therapeutics for obstructive lung diseases.  The Company was formed in 2013 by our scientific founder, Dr. Robert Tarran, based on his discovery of a previously unknown mechanism used by the lung to regulate fluid on the airway surface.  This mechanism is dysfunctional in the lungs of CF patients and is believed to be a root cause of the progressive loss of fluid in the airways of the lung that leads to the unfortunate cycle of mucus dehydration and accumulation, bacterial colonization, immune response and tissue scarring, loss of lung function, and all too often, early death.

Inhalation Solution

Spyryx’s lead investigational product is an inhaled peptide in clinical development to treat CF-related lung disease for all disease-causing mutations.It  has demonstrated compelling evidence of the ability to enhance airway liquid volumes in CF patient cells and to restore mucus clearance in animal models of dehydration induced lung disease.

Spyryx’s product  specifically targets epithelial sodium channels (ENaC) on the airway surface, causing reduction in channel density by cellular internalization. This novel mechanism mimics the airway’s normal regulation of ENaC surface density, decreasing absorption so that fluid is retained on the airway surface. Enhancing fluid levels restores hydration to the resident mucus and promotes its clearance via airway cilia, a process called mucociliary clearance.

Building on the strength of the preclinical and toxicology data  , Spyryx initiated clinical development, completing Phase 1 studies in healthy volunteers and subjects with CF. 

Cystic Fibrosis is a genetic disease that impacts the body’s ability to regulate the flow of salt and water across epithelial membranes, resulting in loss of fluid volume. The respiratory tract is one of the most profoundly affected, causing dehydration-induced lung disease that begins with depleted airway surface liquid and accumulations of dry, sticky mucus and leads to chronic inflammation, recurrent infections, and reduced ability to breathe. Airway fluid dehydration in CF is mediated by ENaC, which are dramatically over-expressed in this disease.

HOPE (Hydration for Optimal Pulmonary Effectiveness) 

Clinical Trial Design:

A randomized, double-blind, placebo-controlled phase II study to evaluate the efficacy and safety of the Inhalation Solution in subjects with cystic fibrosis is underway in Canada, the United Kingdom, France, and Portugal. Additional clinical sites are pending in Italy.

This study will evaluate the efficacy, safety and tolerability of the Inhalation Solution for 28 days in adults 18 – 50 years of age who have a confirmed diagnosis of cystic fibrosis. All CFTR mutations are eligible for this study.