Lyon, France, October 23, 2019 – Alaxia, an affiliate of the Stragen Healthcare Group developing therapeutic solutions for respiratory diseases, today announces it has joined the iABC (inhaled Antibiotics in Bronchiectasis and Cystic Fibrosis) consortium as a partner. The iABC project, consisting of 22 partners in eight European countries, aims to advance the development of two inhaled antimicrobials for patients with cystic fibrosis and bronchiectasis. These patients are at particular risk of respiratory infections, frequently caused by drug-resistant microbes that reduce life expectancy.
Through the consortium, Alaxia will accelerate development of its antibacterial candidate for cystic fibrosis, ALX-009. Alaxia will gain access to all patient and clinical trial networks. It will also have access to expertise on inhaled antimicrobials from iABC members, as well as member support in clinical trials and patient recruitment.
“Alaxia is honored to have been selected to join the iABC project on fighting antimicrobial resistance in patients with lung diseases,” said Philippe Bordeau, VP Innovation and Business Development at Alaxia. “Our ALX-009 candidate has demonstrated strong potential as a therapy against antibiotic resistant lung infections in cystic fibrosis. We look forward to collaborating with iABC members on advancing this drug candidate and discussing this therapeutic opportunity with new financial partners.”
ALX-009 therapy exhibits a new multi-target mode of action that is particularly effective against antibiotic resistant strains and has shown no signs of developing additional resistance. Antimicrobial resistance represents a serious and growing threat to human and animal health worldwide. In the EU alone, antimicrobial resistance is responsible for approximately 25,000 deaths every year.
ALX-009 targets antibiotic-multi-resistant Gram-negative bacteria (‘super bugs’) that are currently untreatable. It combines two endogenous substances: the Hypothiocyanite ion (OSCN–) and the protein Lactoferrin. Both compounds are normally present in healthy people, as part of the body’s first line of defense against microbes: the innate immune system.
In vitro and ex vivo experiments of ALX-009 have demonstrated the 100 per cent susceptibility of gram-negative multi-drug resistant cystic fibrosis isolates; including Burkholderia cepacia complex and other Burkholderia species, multi-drug resistant Pseudomonas aeruginosa, Achromobacter xylosoxidans and Stenotrophomonas maltophilia. These bacteria are not targeted by current therapies and may induce a rapid decline in the respiratory capacity, health status and survival of patients.
The lungs of cystic fibrosis and bronchiectasis patients have large amounts of a sticky mucus (sputum). In this environment, bacteria adopt a multicellular behavior (biofilms) that facilitates survival. Both sputum and biofilms are complex molecular matrices that reduce the efficacy of current antibiotics; to restore their efficacy, a considerable dose increase is needed.
In contrast to available antibiotics, ALX-009 activity is not altered by biofilms or sputum; no significant dose increase is required to maintain its infection killing efficacy.
ALX-009 can be used as a standalone therapy and/or as an adjunctive to antibiotics. It is in the final stages of Phase 1 in cystic fibrosis and bronchiectasis trials. Patient enrolment in Phase 2a trials is planned to start in 2020.
Alaxia will participate in the North American Cystic Fibrosis Conference (NACFC), October 31 – November 2, 2019, in Nashville, TN.
Alaxia, an affiliate of the Stragen Pharma Group, specializes in developing antimicrobial therapies for cystic fibrosis and other chronic respiratory diseases. Its lead product, ALX 009, a first-in-class orphan drug candidate, consists of two endogenous microbiocide substances that provide innate immunity defense within healthy lungs. Currently in the final stages of its Phase 1 trial, ALX 009 aims at treating cystic fibrosis and bronchiectasis infections against multi-drug resistant Gram-negative bacteria.
Alaxia is backed by the French public bank Bpifrance and the Cystic Fibrosis Foundation, with support from Stragen, and now by the iABC consortium. The iABC consortium is a project within the ND4BB program under the IMI (Innovative Medicines Initiative), a Public Private Partnership between the European Union and the European pharmaceutical industry.
Founded in 2008 in Lyon, France, the ALX-009 program is led by Dr. Victor Juarez Perez, project leader and Annie Claude Benichou M.D, chief medical officer, with over 20 Stragen staff.