Biotech hits the brakes on their PhIII pivotal for a lead antibiotic as investigators track a high rate of kidney injuries
The Swiss biotech Polyphor is back with a fresh cautionary tale about the antibiotics sector.
Just days away from its first anniversary of an IPO $POLN that raised $165 million, the developer said late last week that it is halting enrollment in its pivotal trial of its antibiotic murepavadin for nosocomial pneumonia after investigators tracked high rates of acute kidney injury in their Phase III trial.
In the antibiotic arm the rate of injury was 56%, compared to what the company said should usually run from 25% to 40%, depending on historical rates as well as the comparator arm. But the biotech did not specifically compare the drug arm to the rate they were tracking in the control in its statement.
Murepavadin is Polyphor’s leading program, and the chief reason why it was able to raise $165 million a year ago when they went public at $38 a share on the Swiss bourse. That number has shrunk considerably over 12 months, falling another 20% on Monday to a little more than $10 as the markets got a chance to respond to the setback.
Roche had been partnered on this antibiotic for a time, but backed out years ago, one of a number of examples of Big Pharma’s overall retreat from a sector that is both risky and plagued by poor financial returns. Polyphor has been hoping to beat the odds with what it called the first new antibiotic in a half century, touting its outer membrane targeting approach.
“We are trying to better understand the reasons for these events and exploring ideas on how to tackle them for the future, as we remain convinced that murepavadin could still represent a valuable drug to help patients fighting pseudomonas infections,” said Polyphor CMO Frank Weber in a statement.