A new antibiotic that has the potential to save millions of lives has entered its last phase of human testing.
Swiss drugmaker Roche announced it would advance the testing of an antibiotic against a common bacterium that causes serious hospital infections like pneumonia and sepsis into the third and final stage of testing.
The antibiotic zosurabalpin, which is jointly developed with Harvard University, is to be tested against drug-resistant acinetobacter baumannii bacteria.
The Centres for Disease Control and Prevention (CDC) labels acinetobacter baumannii as an “urgent threat”, but there have been no antibiotics created which react to it in more than 50 years.
Roche announced the phase 3 trial will be a single pivotal study with approximately 400 patients from around the world, randomised to receive either zosuarbalpin or the standard treatment.
Michael Lobritz, global head of infectious diseases at Roche, said: “Our goal is to contribute new innovations to overcome antimicrobial resistance, one of the biggest infectious disease challenges to public health.”
Larry Tsai, senior vice president and global head of immunology and product development at Genentech, a unit of Roche, said the drug-resistant bacteria “are present in every country of the world”.
He added that “the innovative biology involved in this research could potentially reveal new insights into the structure of bacterial membranes, possibly leading to the discovery of new antibiotics in the future”.
It is hoped the experimental drug will be approved by the end of the decade.
Globally, sepsis is estimated to cause approximately 11 million deaths each year – one death every 2.8 seconds.
Worldwide, community-acquired pneumonia (CAP) kills three to four million people each year with high morbidity and mortality, particularly among elderly patients.