Lytix Biopharma granted Hungarian approval for Lytixar Phase IIa clinical trial in Gram positive skin infections

Lytix Biopharma ASSep 2 2010

The Norwegian pharmaceutical company Lytix Biopharma AS today announces the approval in Hungary to commence a Phase IIa clinical trial with Lytixar^TM (LTX-109) treatment of skin infections caused by Gram positive bacteria.

According to Lytix Biopharma CEO Gunnar Sælid, "We are delighted to announce the approvals by the Hungarian Regulatory Authorities and appropriate Ethics Committee to test our novel antimicrobial drug Lytixar^TM (LTX-109) in patients whom have skin infections caused by Gram positive bacteria. Skin infections caused by Gram positive bacteria are an ideal patient group in which to test our antimicrobial drug. Standard of care for these types of infections is generally topical drugs, representing a significant market. Since bacteria such as Staphylococcus aureus are often resistant to the exisiting drugs including methicillin-resistance (methicillin-resistant Staphylococcus aureus - MRSA), there is a clear need for a novel drug such as Lytixar^TM. For the Company this is an important study, validating the clinical utility of our novel, broad-spectrum, antimicrobial drug Lytixar^TM."

Preclinical models have demonstrated that Lytixar^TM 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 four hospital dermatology clinics in Hungary. Patients with confirmed Gram positive skin infections will be included in the study and randomized to receive either active drug or placebo in cohorts at ascending dose levels. Lytixar^TM (LTX-109) has the potential to become a valuable new antimicrobial agent for Gram positive skin infections as well as in a range of other indications", concludes Dr. Wenche Marie Olsen, COO and Director of Product Development, Infectious diseases, at Lytix Biopharma AS.