In 2020, Pharma Holdings has conducted an in vitro study to determine the effect of LTX-109 on three enveloped viruses, one being the SARS-CoV-2 virus. The results are compelling and confirm that LTX-109 exerts a virucidal effect against the SARS-CoV-2 virus. Pharma Holdings believes that the in vitro results of LTX-109 on SARS-CoV-2 demonstrate a high potential and a need for clinical translation, and that LTX-109 (preferably, in a gel form) may turn out to be a valuable treatment for COVID-19, and similar respiratory virus infections.
Pharma Holdings is conducting 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 study is approved by the Swedish Medical Products Agency and is scheduled to start recruiting patients on April 20.
In this proposed EU project application, Pharma Holdings aims at demonstrating and validate the clinical efficacy and safety of LTX-109 gel as an innovative anti-viral agent for treatment of SARS-CoV-2 infections in the upper respiratory tract in Phase II / Phase III clinical program.