Cystic Fibrosis Foundation Therapeutics (CFFT) based in Maryland, and Alaxia SAS in France, have entered an agreement to help support the first-in-patient clinical trial of ALX-009, an inhaled antimicrobial drug for patients with cystic fibrosis (CF).
Alaxia, headquartered in Lyon, is a clinical stage developer of medicinal solutions for respiratory diseases based on the company’s proprietary peroxidase platform.
ALX-009, for the treatment of lung infections, is an inhaled combination of two endogenous substances, hypothiocyanite (OSCN–) and lactoferrin, that exhibit antimicrobial properties able to compensate for the defective innate immune system in CF patients.
Under the terms of the new agreement, CFFT paid $1.7 million to Alaxia to advance the development of ALX-009 for patients with CF. The company is currently conducting a Phase 1 clinical study in healthy volunteers and patients with CF.
Alaxia’s General Manager Pascale Gaillard said recent press release that the company is honored that the CCFT recognizes the unique therapeutic potential of the drug candidate.
“This CFFT award enables us to accelerate the clinical development of ALX-009, and we really appreciate working with CFFT on the remaining clinical development path in bringing this new drug to people with cystic fibrosis,” Gaillard said.
The antimicrobial drug has shown therapeutic potential in laboratory tests against a wide range of bacterial species infecting the lungs of CF patients, and particularly against certain bacteria with natural or acquired multi-drug resistance.
The efficacy of ALX-009 is not changed by complex structures, including biofilm or sputum, present in the lung of patients with CF, and has the potential to limit the appearance of resistance and induction of cross-resistance to currently available antimicrobial drugs due to its innovative mode of action.
CF is a genetic disorder that affects mostly the lungs, but can also affect the pancreas, liver, kidneys, and intestine. Long-term issues include difficulty breathing and coughing up mucus as a result of frequent lung infections.
The chronic debilitating disease affects approximately 70,000 people worldwide; more than 30,000 in the U.S. CF is the most common inherited life-limiting genetic condition affecting white populations.