The Norwegian pharmaceutical company Lytix Biopharma AS today announces the approval by the Swedish Medical Products Agency ("Läkemedelverket") to commence a Phase I/IIa clinical trial with LytixarTM (LTX-109) for nasal decolonisation of MRSA (methicillin-resistant Staphylococcus aureus).
According to Lytix Biopharma CEO Gunnar Sælid, "We are delighted to announce the approvals by the Swedish Regulatory Authorities and appropriate Ethics Committee to test our novel antimicrobial drug LytixarTM (LTX-109) in individuals, who are nasal carriers of MRSA. The spread of antibiotic-resistant bacteria such as MRSA in hospitals and the community remains a serious health threat. Health authorities recommend the use of antimicrobial agents for nasal decolonisation in certain groups of patients colonized with MRSA to reduce the risk of infections. For the Company this is an important study, validating the clinical utility of our novel, broad-spectrum, antimicrobial drug LytixarTM."
Preclinical models have demonstrated that LytixarTM is strongly bactericidal, being equally effective against wild-type as well as drug-resistant bacteria such as MRSA. Because of its unique membrane-lysing mechanism of action, there is no cross-resistance to other drugs. It has also proven highly unlikely for bacteria to develop new resistance to the drug.
"The current study will be run at the Skåne University Hospital in Malmö, Sweden, which is a specialist regional referral centre for MRSA. Nasal carriers of MRSA will be included in the study and randomized to receive either active drug or placebo in cohorts at ascending dose levels. LytixarTM (LTX-109) has the potential to become a valuable new antimicrobial agent for nasal decolonization of MRSA", concludes Dr. Wenche Marie Olsen, COO and Director of Product Development, Infectious diseases at Lytix Biopharma AS.