A novel antimicrobial agent for treatment of infections caused by drug-resistant bacteria, preclinical and early phase clinical studie

The present proposal covers preclinical exploratory and Phase I/IIa development programme of LTX-109. The proposal encompasses our internal development program as well as the establishment and management of external production and development programs. L ytix Biopharma AS develop novel antimicrobial drugs for the treatment of challenging infections (e.g. MRSA, GAS, Candida, Aspergillus etc.) into early clinical phases. There is a large unmet medical need for the introduction of new antibiotic drugs. Lytix is now in a unique position to develop a new generation of pharmaceuticals that not only can combat resistant infections, but also have a low propensity for inducing the development of new resistance. We will seek to licence out our candidate molecules t o pharmaceutical companies with sufficient financial strength and expertise in clinical development and marketing. Development of bacterial resistance has been reported for all currently available antibiotic drugs, and there is a generally accepted medic al need for the introduction of new drugs to the clinic. The discovery of naturally occurring antimicrobial peptides in our basal immune system was heralded as a breakthrough and many predicted that these could be used as novel antibiotics. However, becau se of their chemical nature, these native molecules are not suited as pharmaceutical drugs. Through extensive structure-activity relationship (SAR) studies, we have been able to convert these naturally occurring peptides into promising new antibiotic dru g candidates with very interesting pharmaceutical features: - Small-size peptidomimetic molecules - Low production costs - Novel mechanism of action - Metabolically stable - Effective against drug-resistant bacteria - Little chance of developing new res istance