A Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of Topical LTX-109 in Subjects Nasally Colonized With Methicillin-resistant/-Sensitive Staphylococcus Aureus (MRSA/MSSA)

Phase 1/2 Completed 24 enrolled Lytix Biopharma AS

RandomizedSingle-groupTriple-blind

Summary

This is a pilot study conducted to evaluate the safety, local tolerability and efficacy of LTX-109(Lytixar™), a lytic peptide designed to kill bacterias quickly and efficient. LTX-109 (Lytixar™)will be applied in the anterior nares in subjects who are carriers of nasal colonies of MRSA/MSSA. The extent of systemic absorption of LTX -109 when applied to the anterior nares will be evaluated and the effect of Lytixar™ as to clear colonies of MRSA/MSSA during the the observation period and Week 2 to Week 9 after treatment.

Timeline

Start: 2010-05
Primary completion: 2011-04
Completion: 2011-04

Publications

Nilsson AC, Janson H, Wold H, Fugelli A, Andersson K, Hakangard C, Olsson P, Olsen WM. LTX-109 is a novel agent for nasal decolonization of methicillin-resistant and -sensitive Staphylococcus aureus. Antimicrob Agents Chemother. 2015 Jan;59(1):145-51. doi: 10.1128/AAC.03513-14. Epub 2014 Oct 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LTX-109	Peptide	1 %	Intranasal
Subject	LTX-109	Peptide	2 %	Intranasal
Subject	LTX-109	Peptide	5 %	Intranasal

Indications

No indication recorded.