Lytixar (LTX-109) / Lytix - LARVOL DELTA

Lack of Spontaneous and Adaptive Resistance Development in Staphylococcus aureus Against the Antimicrobial Peptide LTX-109. (PubMed, Antibiotics (Basel)) - "Our results demonstrate the novelty of LTX-109 as an antimicrobial agent with no detectable in vitro resistance development in selected clinical strains of MRSA and MSSA."

Journal • Infectious Disease

Multiple-Layer Chitosan-Based Patches Medicated With LTX-109 Antimicrobial Peptide for Modulated Local Therapy in the Management of Chronic Wounds. (PubMed, Macromol Biosci) - "On the top, a protective layer to protect the wound from external contaminations, in the middle a medicated layer loaded with LTX-109 and at the bottom a multifunctional layer to modulate the release of LTX-109. Extensive characterizations show that the patch meets the essential requirements for creating an effective wound healing environment, such as absorption of exudate, maintenance of good oxygen and moisture permeability, biodegradability, biocompatibility, and sustained release of LTX-109 with fully retained antibacterial activity as demonstrated by MIC values obtained against reference bacteria."

Journal • Dermatology • Infectious Disease

Study to Evaluate the Efficacy, Safety and Tolerability of 3% LTX-109 for Nasal Decolonisation of Staphylococcus Aureus (clinicaltrials.gov) - P2a | N=27 | Completed | Sponsor: Pharma Holdings AS

New P2a trial • Infectious Disease

Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection. (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Pharma Holdings AS; Trial completion date: Jun 2021 ➔ May 2022; Trial primary completion date: May 2021 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

LTX-109 as Treatment for Hidradenitis Suppurativa (clinicaltrials.gov) - P1/2; N=11; Completed; Sponsor: Pharma Holdings AS; Recruiting ➔ Completed; N=16 ➔ 11

Enrollment change • Trial completion • Dermatology • Hidradenitis Suppurativa

A Study to Evaluate the Safety and Efficacy of 3% LTX-109 for Nasal Decolonisation of Staphylococcus (clinicaltrials.gov) - P1/2; N=15; Completed; Sponsor: Pharma Holdings AS; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection. (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Pharma Holdings AS; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Study to Evaluate a Single Dose of LTX-109 in Subjects With COVID-19 (Coronavirus Disease 2019) Infection. (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Pharma Holdings AS

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

A Study to Evaluate the Safety and Efficacy of 3% LTX-109 for Nasal Decolonisation of Staphylococcus (clinicaltrials.gov) - P1/2; N=15; Active, not recruiting; Sponsor: Pharma Holdings AS; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

A 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 (clinicaltrialsregister.eu) - P2; N=60; Ongoing; Sponsor: Pharma Holdings AS

New P2 trial • Infectious Disease • Novel Coronavirus Disease

LTX-109 as Treatment for Hidradenitis Suppurativa (clinicaltrials.gov) - P1/2; N=16; Recruiting; Sponsor: Pharma Holdings AS; Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa

A Study to Evaluate the Safety and Efficacy of 3% LTX-109 for Nasal Decolonisation of Staphylococcus (clinicaltrials.gov) - P1/2; N=16; Recruiting; Sponsor: Pharma Holdings AS; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study to Evaluate the Safety and Efficacy of 3% LTX-109 for Nasal Decolonisation of Staphylococcus (clinicaltrials.gov) - P1/2; N=16; Not yet recruiting; Sponsor: Pharma Holdings AS

Clinical • New P1/2 trial

LTX-109 as Treatment for Hidradenitis Suppurativa (clinicaltrials.gov) - P1/2; N=16; Not yet recruiting; Sponsor: Pharma Holdings AS

New P1/2 trial • Dermatology • Hidradenitis Suppurativa

Staphylococcus aureus nasal decolonization strategies: a review. (PubMed, Expert Rev Anti Infect Ther) - "Areas covered: Mupirocin nasal ointment has been used for the nasal decolonization and prevention of staphylococcal infections in various settings like surgeries...Some old approved antiseptics (chlorhexidine, povidone-iodine) or antibiotics (rifampicin, bacitracin) have been investigated for their efficacy in this indication. Other new agents (tea tree oil, retapamulin, LTX-109, XF-73, phages, lysostaphin, squalamine analogues, etc.) are being studied. Some of them are still in preclinical phases, and others have reached clinical trials, but further research is needed. Special interest should be given to single dose decolonization strategies and to molecules that do not select resistant strains."

Journal