Siglec-10 antagonists(Sialic acid-binding Ig-like lectin 10 antagonists), Siglec-15 inhibitors(Sialic acid-binding Ig-like lectin 15 inhibitors), Siglec-8 inhibitors(Sialic acid-binding Ig-like lectin 8 inhibitors)

+ [1]

Therapeutic Areas

Congenital DisordersDigestive System DisordersRespiratory Diseases+ [1]

Active Indication-

Inactive Indication

Cystic FibrosisNon-cystic fibrosis bronchiectasis

Originator Organization

Alaxia SAS

Active Organization-

Inactive Organization

Alaxia SAS

Drug Highest PhaseDiscontinuedPhase 1

First Approval Date-

Regulation-

Clinical Trials associated with ALX-009

NCT02598999 / TerminatedPhase 1

Randomized, Double Blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics After Single Ascending Doses or Multiple Ascending Doses of OSCN-, bLF or ALX-009 in Healthy Male and CF and Non-CF Bronchiectasis Patients

This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of a single ascending doses (SAD) and multiple ascending doses (MAD) of Hypothiocyanite (OSCN-), bovine lactoferrin (bLF) and their combination (ALX-009) in healthy male volunteers and patients suffering from cystic fibrosis (CF) and non-CF bronchiectasis (NCFBE).

Start Date01 Nov 2015

Sponsor / Collaborator

Alaxia SAS

100 Clinical Results associated with ALX-009

100 Translational Medicine associated with ALX-009

100 Patents (Medical) associated with ALX-009

Literatures (Medical) associated with ALX-009

Journal of Antimicrobial ChemotherapyQ2 · MEDICINE

Activity of hypothiocyanite and lactoferrin (ALX-009) against respiratory cystic fibrosis pathogens in sputum

Q2 · MEDICINE

Article

Author: McGrath, Stephanie J ; Juarez-Perez, Victor ; Tunney, Michael M ; Payne, Joanna E ; Ingram, Rebecca J ; Einarsson, Gisli G ; Gilpin, Deirdre F ; Elborn, J Stuart

ObjectivesTo determine the antimicrobial activity of ALX-009, a combination of bovine lactoferrin and hypothiocyanite, in sputum against Pseudomonas aeruginosa and Burkholderia cepacia complex (Bcc), key pathogens causing infection in the lungs of cystic fibrosis (CF) patients.MethodsThe antimicrobial activity of ALX-009 against clinical respiratory P. aeruginosa isolates was determined by time-kill assay. Sputum from CF patients was treated with ALX-009, either alone or in combination with tobramycin, and the effect on P. aeruginosa, Bcc and total sputum density was determined.ResultsTime-kill assay indicated that ALX-009 was bactericidal at 24 h against 4/4 P. aeruginosa isolates under aerobic conditions, and against 3/4 isolates under anaerobic conditions. ALX-009 was also bactericidal against P. aeruginosa in sputum samples at 6 h (n = 22/24 samples) and 24 h (n = 14/24 samples), and demonstrated significantly greater activity than tobramycin at both timepoints. Activity against Bcc in sputum samples (n = 9) was also demonstrated, but the magnitude of change in Bcc density was less than for P. aeruginosa. 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.ConclusionsALX-009 demonstrates promise as a novel antimicrobial that could be used to decrease P. aeruginosa density in the lungs of people with CF.

100 Deals associated with ALX-009

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Cystic Fibrosis	Phase 1	FR	Alaxia SAS	01 Nov 2015
Non-cystic fibrosis bronchiectasis	Phase 1	FR	Alaxia SAS	01 Nov 2015

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