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Nasal Decolonization of Staphylococcus Aureus

A Phase I/IIa, double-blind, placebo-controlled, randomised study designed to evaluate the safety, tolerability and exploratory efficacy of LTX-109 administered topically to the anterior nares in subjects with persistent carriage of S. aureus (methicillin-susceptible S. aureus [MSSA] and/or methicillin-resistant S. aureus [MRSA]).

There is an established link between successful decolonization of S. aureus and reduced perioperative infection risk for high-risk surgery patients. The study aims to demonstrate the safety and preliminary efficacy of LTX-109 as an innovative antimicrobial reagent for prophylactic decolonisation of nasal S. aureus in connection with elective surgery. Nasal decolonisation with LTX-109 is expected to reduce nosocomial S. aureus infections, both MSSA and MRSA, with a very low likelihood of resistance development because of LTX-109’s novel mechanism of action.

The participating subjects will be treated with an intensive dosing regimen. Compared to a “standard of care” dosing regimen with treatment for up to five days, the aim is to obtain satisfactory results after only six hours of treatment. There are several future benefits linked to this regimen: Patients will be more rapidly eligible for surgery and the compliance will most likely be improved.

Primary objective

To evaluate the safety and tolerability of LTX-109 (3%) gel applied in an intensive dosing regimen to the anterior nares in healthy volunteers who have

persistent carriage of S. aureus (MSSA and/or MRSA).

Exploratory objectives

– To explore the efficacy of LTX-109 (3%) gel in an intensive regimen as evaluated by measuring the eradication rate (number of subjects eradicated).
– To determine the extent of systemic absorption of LTX-109 after application to the anterior nares

Number of subjects planned

Approximately 60 subjects will be screened to achieve enrolment of 16 randomised and dosed subjects. For more information regarding the ongoing study, see: https://clinicaltrials.gov/ct2/show/NCT04767321?term=pharma+holdings&draw=2

Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic, inflammatory, recurrent, scarring, debilitating skin disease, which usually presents after puberty with a prevalence around 1% for adults and declining after age 50. It presents with painful, deep-seated, inflamed lesions in the apocrine gland-bearing areas, most commonly the axillae, inguinal and anogenital regions. HS also inflicts a significant burden on patients and is associated with comorbid diseases like pyoderma gangrenosum, arthritis, anemia, significantly reduced quality of life, depression and stigmatization.
Objective
Open label Phase I/II proof of concept-study to demonstrate if percutaneous application of LTX-109 in a gel vehicle is a safe treatment of Hidradenitis suppurativa and to identify clinical response to intervention, as well to identify if covariates such as age, disease duration, smoking state and BMI influence patient reported measures investigate.
Time Frame: Interim analysis after 3 weeks. End point analysis after 6 weeks. Follow-up analysis after 3 months.
Primary endpoint
Investigator assessed signs and patient reported symptoms for local reactions to the IMP.
Secondary Endpoints
▪ Patient reported improvement after invention with LTX-109 gel, outcome measured by Dermatology Life Quality Index (DLQI)-scores and self-reported disease activity and pain experience.

▪ Investigator scored measures assessed by Hidradenitis suppurativa score (Sartorius), and number of inflammatory lesions and IHS-4.

▪ Covariate analysis on patient recorded DLQI and self-reported disease activity and pain experience in relation to pre-registered variables.

▪ Patient recorded DLQI and self-reported disease activity and pain experience in relation to clinical phenotypes (Hidradenitis suppurativa score (Sartorius), Hurley stage, IHS- 4).

Number of subjects planned

Approximately 16 patients are planned enrolled in the study.
For more information regarding the ongoing study, see: https://clinicaltrials.gov/ct2/show/NCT04756336?term=pharma+holdings&draw=2

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 (h) post-dosing.
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