bovine-lactoferrin/hypothiocyanite (ALX-009) / Alaxia - LARVOL DELTA

Antibiotics and non-traditional antimicrobial agents for pseudomonas aeruginosa in clinical phases 1, 2, and 3 trials. (PubMed, Expert Opin Investig Drugs) - "Traditional agents in clinical development include β-lactam/β-lactamase inhibitors (funobactam, taniborbactam, QPX2014-xeruborbactam), aminoglycosides (apramycin), polymyxin derivatives (upleganan, MRX-8, and SPR741), fluoroquinolones (MP-376), and lipopolysaccharide transport inhibitors (murepavadin). Non-traditional antibiotics in clinical development include anti-virulence agents (fluorothiazinone), monoclonal antibodies (INFEX-702, TRL-1068, and CMTX-101), bacteriophages (AP-PA02, YPT-01, BX004-A, and WRAIR-PAM-CF1), and miscellaneous agents (AR-501, PLG-0206, SNSP-113, OligoG CF-5/20, and ALX-009). A considerable number of antimicrobial agents, some with novel mechanisms of action, are in clinical phases of development for treating Pseudomonas aeruginosa infections. The urgent need for more therapeutic options necessitates the rapid optimization of progress to introduce new agents into clinical practice."

Journal • Review • Infectious Disease

Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients (clinicaltrials.gov) - P1 | N=92 | Terminated | Sponsor: Alaxia SAS | Recruiting ➔ Terminated; Financial issues

Trial termination • Bronchiectasis • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • CXCL8 • IL10 • IL1B • IL6 • TNFA

Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients (clinicaltrials.gov) - P1; N=103; Recruiting; Sponsor: Alaxia SAS; Trial completion date: Feb 2020 ➔ Oct 2021; Trial primary completion date: Feb 2020 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • CXCL8 • IL10 • IL6

Hypothiocyanite and Hypothiocyanite/Lactoferrin Mixture Exhibit Virucidal Activity In Vitro against SARS-CoV-2. (PubMed, Pathogens) - "The Food and Drug Administration and the European Medicines Agency designated the hypothiocyanite and lactoferrin combination as an orphan drug. We report an in vitro study showing that micromolar concentrations of hypothiocyanite exhibit dose- and time-dependent virucidal activity against SARS-CoV-2 and that the latter is slightly enhanced by the simultaneous presence of lactoferrin."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Alaxia breaks new ground with lead compound ALX-009 as virucidal agent (PharmiWeb) - "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...Alaxia’s in vitro and ex vivo tests showed 100% efficacy on several strains...A scientific paper, detailing BSL3 lab tests results, will be submitted for peer review before the end of 2020...The company has started recruiting cystic fibrosis and bronchiectasis patients at several EU clinical sites to complete this ongoing study (phase 1b)."

Enrollment status • Preclinical • Cystic Fibrosis

Nasal disinfection for the prevention and control of COVID-19: A scoping review on potential chemo-preventive agents. (PubMed, Int J Hyg Environ Health) - "Effective and safe chemo-prophylactic drugs against SARS-CoV-2 do not exist yet but most eligible candidates are already in the market. Whilst the human nasal cavity is the port of entry for SARS-CoV-2, the mouth is involved as exit site through emission of respiratory droplets. The well-known hand-to-nose-to-hand cycle of contamination requires appropriate additional strategies for infection control. To narrow down the subsequent laboratory and clinical investigations, a case-control approach could be employed to compare the use of candidate drugs among individuals testing positive and negative to COVID-19 swabs."

Journal • Infectious Disease • Novel Coronavirus Disease • Otorhinolaryngology

Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients (clinicaltrials.gov) - P1; N=66; Not yet recruiting; Sponsor: Alaxia SAS

Clinical • New P1 trial

Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients (clinicaltrials.gov) - P1; N=66; Recruiting; Sponsor: Alaxia SAS; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients (clinicaltrials.gov) - P1; N=66; Recruiting; Sponsor: Alaxia SAS; Trial primary completion date: Dec 2016 ➔ Jun 2017

Clinical • Trial primary completion date

Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients (clinicaltrials.gov) - P1; N=103; Recruiting; Sponsor: Alaxia SAS; Trial completion date: Dec 2018 ➔ Feb 2020; Trial primary completion date: Dec 2018 ➔ Feb 2020

Clinical • Trial completion date • Trial primary completion date

Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients (clinicaltrials.gov) - P1; N=124; Recruiting; Sponsor: Alaxia SAS; N=66 ➔ 124; Trial primary completion date: Jun 2017 ➔ Dec 2018

Clinical • Enrollment change • Trial primary completion date

Activity of hypothiocyanite and lactoferrin (ALX-009) against respiratory cystic fibrosis pathogens in sputum. (PubMed, J Antimicrob Chemother) - "To determine the effect of treating sputum with two doses of ALX-009, similar to current regimens for inhaled antibiotics, aliquots of a further 10 sputum samples positive for P. aeruginosa were treated with one (t = 0 h) or two doses (t = 0 h, t = 12 h) of ALX-009; treatment with two doses resulted in bactericidal activity in 7/10 samples at 34 h compared with only 3/10 samples when treatment was with one dose. ALX-009 demonstrates promise as a novel antimicrobial that could be used to decrease P. aeruginosa density in the lungs of people with CF."

Journal