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Ongoing study (COVID-19

A Phase IIa, double-blind, placebo-controlled, interventional parallel group study to evaluate the antiviral effect of a single nasal application of LTX-109 3% gel, in comparison to placebo gel, in subjects with COVID-19 infection. The aim of this Phase IIa study is to establish that LTX-109 can be an effective antiviral drug against SARS-CoV-2 by aiming to reproduce in vitro findings against SARS-CoV-2 in a clinical setting. The nose is known to be the main site for initial SARS-CoV-2 virus replication before the virus migrates to the lower respiratory tract and causes pneumonia. Our aim is to eradicate the virus in its main replication site. With positive data from this phase IIa trial, we will proceed with a follow-up phase IIb study with multiple dosing throughout the replication cycle to achieve a significant reduction in viral load or even a complete eradication. By achieving this we hope to see linked clinical benefits such as shortened duration of symptoms and reduced risk of progression to severe disease (moderate to severe COVID-19).
Primary objective

The primary objective is to evaluate the effect of a single dose of LTX-109 3% nasal gel on SARS-CoV-2 viral load in the deep nasal cavity in subjects with COVID-19 infection, as compared to placebo.
The primary endpoint is reduction in SARS-CoV-2 viral load from baseline (pre-dose) to 2 hours post-dosing.

End of trial

Expected final inclusion of subjects during April, and thereby
readouts by end of May 2022

Secondary objectives
– To evaluate the effect of a single dose of LTX-109 3% nasal gel on SARS-CoV-2 viral load in the anterior nose in subjects with COVID-19 infection, as compared to placebo.
– To evaluate safety and tolerability of a single dose of LTX-109 3% nasal gel, as compared to placebo.
Exploratory objectives
Change in symptoms score (frequency and intensity of symptoms) during the 7-day period following administration of the investigational medicinal product, using 10 pre-defined questions.
Number of subjects planned

A total of 60 subjects will be randomised 1:1 to one single dose of either active treatment (LTX-109 3% hydrogel) or matching placebo.
For more information regarding the ongoing study, see:
https://clinicaltrials.gov/ct2/show/NCT04854928?id=NCT04458519+OR+NCT04357990+OR+NCT04421534+OR+NCT04316377+OR+NCT02575950+OR+NCT04529460+OR+NCT00403949+OR+NCT00232115+OR+NCT03915470+OR+NCT04767321+OR+NCT04590365+OR+NCT04854928&draw=2&rank=1&load=cart