A little more than a year after the FDA sent Tetraphase back to the Phase III drawing board after dissing their application for the antibiotic eravacycline, the biotech is back touting a positive batch of late-stage data. And its shares $TTPH took off on the news, soaring more than 30% on the prospect of a turnaround.
These data come from IGNITE4, the Watertown, MA-based biotech’s do-over, which was required after the FDA asked for one more Phase III study. Looking at a modified intent-to-treat population, Tetraphase says that it gained clear evidence that its antibiotic was non-inferior to meropenem in treating complicated intra-abdominal infections. That trial enrolled 500 patients.
The success sets up a filing with the FDA in the next nine months. And in the meantime, the biotech says it is on track with another Phase III for once-daily IV in combatting urinary tract infections.
Tetraphase, though, already posted a positive Phase III for intra-abdominal infections in 2014. It was the Phase III for UTIs that flopped, sending its shares into a tailspin that forced the biotech to regroup. That setback also triggered the decision at the agency to ask for more Phase III data before it would consider a green light on marketing.
“The successful outcome of this second of two pivotal phase 3 trials investigating twice-daily IV eravacycline for the treatment of cIAI is a critical achievement for Tetraphase as we continue preparations to submit our first NDA to the FDA for IV eravacycline, which we expect in the first quarter of 2018,” said Guy Macdonald, president and CEO of Tetraphase. “I would like to express my sincere gratitude to all of the patients and physicians that participated in the IGNITE4 and IGNITE1 studies. We believe that eravacycline has the potential to play a key role in the treatment of serious hospital infections, and we are another step closer to realizing that goal.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 24,000+ biopharma pros who read Endpoints News by email every day.Free Subscription