US-based pharmaceutical company Eagle Pharmaceuticals has randomised the first patient in its Phase II trial evaluating CAL02 as an adjunctive therapy to standard of care in treating severe community-acquired bacterial pneumonia (SCABP).

The placebo-controlled, multi-centre study is designed to assess CAL02's safety and efficacy in patients with SCABP.

It intends to enrol 276 patients at more than 100 sites in more than 20 countries. The patients will receive intravenous administrations of the dosage.

As CAL02 does not appear to exert any selective pressure, it can be administered empirically together with the standard of care as soon as patients have symptoms of severe pneumonia.

Eagle Pharmaceuticals Clinical Drug Development senior vice-president and interim chief medical officer Dr Valentin Curt said: “CAL02, a first-in-class, broad-spectrum, anti-virulence agent under development for the treatment of SCABP, neutralises the most common virulence factors.

“It has the potential to mitigate organ damage, pro-inflammatory responses, and to facilitate killing the underlying pathogen without contributing to antibiotic resistance.

“We are excited by the opportunity to build on the promising clinical results of the Phase I first-in-human study, with the goal of advancing SCABP patient care and providing critical care and infectious disease physicians with urgently needed additional treatment options.”

By the end of September this year, Eagle Pharmaceuticals expects to have nearly 50 sites activated for enrolling patients. The remaining sites are expected to be ready by the end of the year.

Interim results of the trial are due to be released around the first quarter of next year.

Eagle Pharmaceuticals president and CEO Scott Tarriff said: “We believe CAL02 has the potential to elevate the standard of care for severe bacterial pneumonia, and we are delighted to be moving this clinical programme forward.

“While we are currently focused on the US we have a worldwide licence, which could result in additional commercial markets for CAL02 in the future.”