- Pfizer said on Thursday an experimental antibiotic it’s been developing effectively treated drug-resistant bacterial infections in two Phase 3 trials.
- The results come from studies evaluating the antibiotic, known as ATM-AVI, in people with complicated intra-abdominal infections or bacterial pneumonia. Pfizer reported comparable cure rates among patients treated with ATM-AVI and those who received a generic drug and older antibiotic treatments, though the studies weren’t designed to evaluate efficacy. There were no severe treatment-related side effects either, Pfizer said.
- The findings position Pfizer to file for regulatory approvals in the second half of the year. The antibiotic, a combination of the antibiotics aztreonam and avibactam, would be used against gram-negative bacterial infections, which are particularly difficult to treat.
The World Health Organization has called the rise in antibiotic resistance one of the biggest threats to global health. Yet the pipeline of drugs being developed for gram-negative bacteria is particularly sparse, an issue of growing importance given their ability to evade existing therapies.
Still, the problem has yet to be solved. Antibiotics are administered in a short course, and new ones are used sparingly to slow potential resistance, making commercialization a challenge. Some drugmakers have also argued that the incentives signed into U.S. law more than a decade ago — as well as newer “subscription-style” purchasing models — don’t go far enough to spur research, especially for small biotechnology companies.
Those factors have heightened the importance of the drugs currently being developed, among them Pfizer’s ATM-AVI. Pfizer bought into the program when it acquired AstraZeneca’s small molecule anti-infectives business in 2016. That deal gave Pfizer commercial rights everywhere except the U.S. and Canada, where AbbVie has ownership. Pfizer also received federal funding to complete clinical testing.
In one study, ATM-AVI was combined with the antibiotic metronidazole and evaluated in patients hospitalized with either complicated intra-abdominal infections or pneumonia. In the other, ATM-AVI was tested against confirmed gram-negative infections. In addition to appearing comparable to existing therapies, the treatment was “well-tolerated,” with a profile similar to aztreonam alone, Pfizer said.
“We believe these data demonstrate that ATM-AVI, if approved, could be an important treatment option for patients with life-threatening bacterial infections that are resistant to almost all currently available antibiotics,” said James Rusnak, the senior vice president and chief development officer of internal medicine in Pfizer’s anti-infectives and hospital division, in a statement.
Pfizer intends to file approval applications in China, the U.K., Europe and U.S.