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Alaxia breaks new ground with lead compound ALX-009 as virucidal agent
ALX-009, developed as an antimicrobial drug for antibiotic resistant infections in lungs of Cystic Fibrosis patients, shows encouraging results in inactivating SARS-CoV-2 virus

 

Scientific paper, detailing BSL3 lab tests results, will be submitted for peer review before year-end

Lyon, France, September 21, 2020 – Alaxia, an affiliate of the Stragen Pharma Group developing therapeutic solutions for respiratory diseases, today announces a cooperation with a BSL3 (BioSafety Level 3) laboratory of University of Padova (Department of Molecular Medicine, DMM) to test in vitro the virucidal effect of the antimicrobial compound ALX-009 (combination of OSCN- and lactoferrin) against SARS-CoV-2, the virus responsible for Covid-19. The tests reinforce the interest in investigating ALX-009 against bacterial and viral lung infections and/or co-infections, in a broader range of life-threatening agents.

ALX-009, the company’s lead compound, is an antimicrobial product originally developed for Cystic Fibrosis (CF) patients to fight antibiotic multi-resistant Gram negative bacteria. Current therapies do not target these bacteria, that induce a rapid decline in the respiratory capacity, health status and survival of patients. Alaxia’s in vitro and ex vivo tests showed 100% efficacy on several strains (Burkholderia spp., multi-drug resistant Pseudomonas aeruginosa, Achromobacter spp. and Stenotrophomonas spp.).

In 2013 Alaxia, in collaboration with DMM, tested hypothiocyanite (OSCN-) in vitro against A/H1N1 2009 pandemic influenza virus, showing a clear dose-dependent virucidal activity without cell toxicity. According to Luca Cegolon – medical epidemiologist who promoted Influenza and SARS-CoV-2 investigations: “This compound has considerable potential. Not only does it show great promise in the treatment of cystic fibrosis patients, but it clearly has a large spectrum cidal activity. Indeed, since OSCN- is an endogenous molecule and is part of the natural human immune system against pathogen threats, the risk of side effects in humans is inevitably low”.

During summer 2020, Alaxia and DMM started to investigate the potential of ALX-009 on SARS-CoV-2. “Seeing preliminary results, additional tests will be performed to confirm the potential virucidal activity of ALX-009 on SARS-CoV-2,” said Cristiano Salata from DMM. A scientific paper, detailing BSL3 lab tests results, will be submitted for peer review before the end of 2020.

ALX-009 is produced extemporaneously by dedicated equipment EOLEASE as and when needed for managing multiresistant bacterial infections. ALX-009 was developed to be administered by inhalation. In February 2020 Alaxia completed its phase 1 clinical trial cohorts enrolling 84 healthy volunteers (phase 1a) to study the safety profile of the compound. ALX-009 was deemed safe to inhale. The company has started recruiting cystic fibrosis and bronchiectasis patients at several EU clinical sites to complete this ongoing study (phase 1b).

“The promising effect on SARS-CoV-2 suggests that ALX-009 can be an antimicrobial with virucidal properties. With the phase 1 clinical trial data, we were able to determine that ALX-009 is a safe breathable antimicrobial drug candidate. It could be an important tool to treat a large array of life threatening agents in CF,” said Philippe Bordeau, VP Innovation and Business Development at Alaxia. “We look forward to increasing the interest around ALX-009 and to finding one or more partners to hasten our development programs.”

About ALX-009
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. The drug can be used as a stand-alone therapy and as an adjunctive to antibiotics or other therapeutics.
In vitro and ex vivo tests have shown that the bactericidal effect was maintained in complex matrices (biofilm and sputum) which is important as it works without requiring significant dose increases for respiratory infections in cystic fibrosis. ALX-009 has orphan drug status both in the US and the EU. Both the drug and the technologies are patented.

About Alaxia
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 a phase 1b 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 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

The press release can be found here

 

Alaxia joins EU consortium to combat drug-resistant lung infections
Partnership in iABC project will accelerate Alaxia’s development of promising antimicrobial therapy for cystic fibrosis

 

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.

About Alaxia
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.

The press release can be found here: Alaxia joins EU consortium to combat drug-resistant lung infections

ALX 009 / Cystic Fibrosis Foundation / Pipeline :
A Phase 1 study to test the safety and tolerability of ALX-009 is underway.

 

 

Alaxia Announces $1.7 Million Award from Cystic Fibrosis Foundation Therapeutics to Start Clinical Development of ALX-009 in Patients

 

Lyon, France, June 30th, 2016. Alaxia SAS announced today an agreement with Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), Bethesda, Md., to help support the first-in-patient clinical study of its inhaled antimicrobial drug candidate ALX-009.
By delivering two key endogenous antimicrobial substances directly to the lung, ALX-009 is intended to compensate for the defective innate lung defense system of people with cystic fibrosis (CF). ALX-009 already demonstrated in vitro its therapeutic potential against a wide range of bacterial species infecting CF lungs and particularly against clinical isolates with natural or acquired multi-drug resistance. ALX-009 efficacy is not altered by complex structures such as biofilm or sputum present in CF lungs. ALX-009 has the potential to limit emergence of resistance and induction of cross-resistance to available antibiotics thanks to its innovative mode of action. A Phase I clinical trial involving healthy volunteers and CF patients is ongoing.
CFFT, the nonprofit drug discovery and development arm of the Cystic Fibrosis Foundation, committed $1.7 million to Alaxia to expedite the development of ALX-009 for cystic fibrosis patients.

Pascale Gaillard, General Manager of Alaxia, commented on the award: “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. 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.”

About Cystic Fibrosis:
Cystic fibrosis (CF) is a life-threatening disease that affects the lungs and digestive system and impacts about 70,000 people worldwide. CF is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene which results in either no CFTR protein or an abnormal CFTR protein that does not function properly. This dysfunctional protein causes the body to accumulate excessive levels of unusually thick mucus in the lungs. This excessive sticky mucus becomes a site for recurrent infections that can require hospitalization. Respiratory distress in CF — defined as acute difficulty in breathing, infection and/or hospitalization — is most commonly related to mucus accumulation and lung infections that result in damage to lung tissue.
For more information on CF, please visit www.cff.org

About Alaxia SAS:
Alaxia SAS is a French clinical stage biotech company affiliated to Stragen Pharma and supported by BPI France. For additional info, please, visit www.alaxia-pharma.eu
Alaxia’s aim is to address unmet medical needs, fighting infections through its innovative Hypothiocyanite/Lactoferrin technology, by developing products and therapies to market or license to suitable partners.
Contact: Philippe Bordeau, VP Innovation, +33 437 532 637, philippe.bordeau@bioalaxia.eu

The CFFT press release can be found here: CFF Press Release

 

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