Tetraphase $TTPH is 0 for 2 in Phase III studies of its IV antibiotic eravacycline for complicated urinary tract infections.
Researchers for the biotech say the antibiotic failed to achieve statistical non-inferiority to ertapenem on cUTIs, leaving it at a dead end. The biotech’s shares were once again shattered on the setback, plunging 58%.
The Watertown, MA-based biotech was snubbed at the FDA more than a year ago when it tried to get a green light for the antibiotic in the wake of one success and one failure in late-stage studies. Tetraphase had one positive result for complicated intra-abdominal infections and the flop on complicated UTIs when regulators sent them back in search of at least one more positive study ahead of any approval.
Now Tetraphase is left with mirror results from the first round of Phase IIIs, with plans to keep pushing for an approval on intra-abdominal infections while trying to figure out what keeps going wrong on the UTI front. The biotech’s shares plunged after the Phase III failure in the fall of 2015, and have yet to recover to their old heights.
Several biotechs have been pushing hard in Phase III on a new wave of antibiotics. Largely abandoned by the big players who don’t like the thin margins and prevalence of cheap generics, the group of biotechs are left to handle most of the innovation in a field that has been crying out for new options amid rising rates of drug resistant threats. Still, even with new federal incentives antibiotic development remains hard, plagued by setbacks like this and not so easy to market when they do pass muster.
Said CEO Guy Macdonald:
There is a clear unmet need for patients with serious infections, particularly those caused by difficult-to-treat Gram-negative bacteria, and we continue to believe that eravacycline can benefit those patients and we are excited to be getting closer to delivering that potential to patients in need.