(LSE:XTL) announced on Wednesday that it had begun conducting clinical Phase II trials of its XTL-001 drugs on humans, for the treatment of viral hepatitis B (HBV).
Sixty patients are to take part in the trials to be held in medical centers both in Israel and abroad.
XTL-001 consists of two monoclonal antibodies that target various sites of the virus. The antibodies were developed via XTL's Trimera technology.
XTL recently completed the successful Phase I trial of its drug on 27 patients. The trial involved a one-time dose, as well as administration of the drug over a period of one month. The tests established the safety in using the drug, and the absence of significant side effects. Long-term administration showed that the drug quickly reduced the virus level among the Phase I patients.
The purpose of the Phase II trial is to examine the effect of the drug over a one-year period.
The trials will also examine the use of XTL-001 with Lamivudine, among the few drugs approved for the treatment of HBV.
Lamivudine reduces the virus level among most patients, but its ability to fully cure a patient is limited.
XTL President and CEO Martin Becker said that the commencement of Phase II is an important step in the realization of XTL's strategy, which seeks to combine antibody-based drugs with anti-viral drugs in the treatment of viral diseases. Becker believes that using XTL-100 and Lamivudine, which act in complementary systems, will improve the existing treatment of HBV.
There are 350 million people around the globe infected with hepatitis B, and it is one of the leading causes of death worldwide. A quarter of the chronic HBV-patients are expected to die prematurely as a result of liver complications, including cirrhosis, scarring of the liver, and liver cancer.
XTL develops drugs for treating HPV, HBC, and other infectious diseases. The drugs are based on human monoclonal antibodies and other synthetic compounds. The company has developed a technology that facilitates the accelerated development of drugs.