Alaxia SAS announced that it has received $1.7 million from the Cystic Fibrosis Foundation Therapeutics (CFFT), the non-profit drug discovery and development arm of the Cystic Fibrosis Foundation (CFF), to support and advance a first clinical study of its inhaled antimicrobial drug candidate, ALX-009, as a therapy for people with cystic fibrosis (CF).
The randomized, double-blind and placebo-controlled Phase 1 trial, titled “First-in-man Dose Escalation Study of ALX-009 and Its Components in Healthy Men and Cystic Fibrosis Suffering Patients” (NCT02598999), is now recruiting participants at its site in Grenoble, France.
It will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of hypothiocyanite (a bacterial agent), bovine lactoferrin (an iron-binding glycoprotein derived from cows) — two compounds with antimicrobial properties – or their combination (ALX-009) in healthy male volunteers and CF patients.
The trial’s primary outcomes, safety and tolerability, will be assessed in three arms:
- Single administration of hypothiocyanite, lactoferrin, or placebo in healthy volunteers (cohorts 1 to 3)
- Single and multiple doses of ALX-009 or placebo in healthy volunteers (cohorts 4 and 5)
- Single and multiple doses of ALX-009 or placebo in CF patients (cohort 6)
ALX-009 is designed to compensate for the defective lung defense system innate to CF by delivering two key endogenous antimicrobial substances directly to the lungs. The drug’s efficacy is not altered by complex structures like biofilm or sputum, often found in the lungs of CF patients. In vitro tests have demonstrated the therapeutic potential of ALX-009 against a broad range of bacterial species, and particularly against clinical isolates with natural or acquired multi-drug resistance.
ALX-009 can potentially limit the emergence of resistance – and induction of cross-resistance – to available antibiotics, the company reported.
“We are honored and delighted that Cystic Fibrosis Foundation Therapeutics recognizes the unique therapeutic potential of our drug candidate by supporting the development of ALX-009,” Pascale Gaillard, Alaxia’s general manager, said in a press release. “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.”
For more information about the clinical trial and how to participate, please visit the link.