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news.US-based XBiotech has started treatment in its Phase I/II clinical trial designed to evaluate dosing, safety and efficacy of a new antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA).
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The company’s therapy, called 514G3, was developed from a human donor with natural antibodies effective at neutralizing MRSA and non-MRSA forms of S. aureus.
According to the company, the first patient treated in the trial had confirmed MRSA bacteremia that was life threatening and within 24 hours of receiving a single, low dose of the therapy, the patient had no fever and white blood cell counts began to normalize.
The observations showed that rapid control of the infection was achieved upon administration of the antibody. The Phase I/II clinical trial of 514G3 is expected to be completed by the first quarter of next year.
The company noted that 514G3 is expected to treat all strains of MRSA and can be used without consideration for strain-specific resistance to various antibiotics.
As a True Human monoclonal antibody, the company also expects 514G3 to be tolerated without the side effects or risks of antibiotics.
XBiotech chief executive officer John Simard said: "The ability to treat lethal drug-resistant bacterial infections with a therapy isolated from a human being with natural immunity to the disease is simply a breakthrough approach to creating new medicines."
"Our entire team at XBiotech will bring the utmost urgency to providing this therapy to as many patients in as many centers as possible."
Around 52 patients will be enrolled in this randomized, placebo-controlled, dose escalation trial at about 16 clinical sites in the US, Europe and Southeast Asia.
These patients with S. aureus bacteremia will be randomized to receive 514G3 plus standard of care antibiotics or placebo plus antibiotics.
The company said that the trial will be unblinded during the Phase I dose escalation stage, where the maximum tolerated dose will be determined, followed by a Phase II study designed to evaluate efficacy against S. aureus infection.