- Merck & Co. intends to file its marketed antibiotic Zerbaxa for two new indications following positive results from a Phase 3 pivotal study.
- Dubbed ASPECT-NP, the study showed Merck's drug was non-inferior to another antibacterial agent, meropenem, in the treatment of adults with either ventilated hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).
- Zerbaxa combines a novel cephalosporin, ceftolozane, with a beta-lactamase inhibitor, tazobactam. Developed under Cubist Pharmaceuticals before falling into Merck's hands, the drug first gained U.S. approval in 2014 for adults with complicated intra-abdominal infections and complicated urinary tract infections.
The world needs new antibiotics.
That was the overarching message from a World Health Organization report issued last September. The report found most antibiotics in development are modified versions of existing drugs, and that treatments for antibiotic-resistant illnesses were few and far between.
"There is an urgent need for more investment in research and development for antibiotic-resistant infections including [tuberculosis], otherwise we will be forced back to a time when people feared common infections and risked their lives from minor surgery," WHO Director-General Tedros Adhanom Ghebreyesus said in a statement at the time.
Government agencies and third party organizations have tried to address the need by incentivizing further antibiotic R&D, but in many cases haven't outweighed long-standing concerns about reimbursement and return on investment.
Just a few months ago, Novartis joined a growing list of big pharmas exiting the antibiotics space. And on the biotech side of things, investors are proving quite difficult to please in spite of positive readouts, regulatory advances and M&A activity.
Against that gloomy backdrop, Merck this year has touted some news from its antibiotics business.
The company's investigational beta-lactamase inhibitor relebactam scored in a pivotal Phase 3 trial that paired it with imipenem and cilastatin for the treatment of infections that aren't susceptible to imipenem. Another pivotal trial of relebactam is ongoing, but a positive readout there would further support Merck's plan to submit the drug for approval.
As for Zerbaxa, ASPECT-NP data indicated the drug worked about the same as meropenem as measured by Day 28 all-cause mortality and by clinical cure rate. Merck said it expects to submit results from the study for presentation at a future scientific conference.
"HABP and VABP are serious and life-threatening hospital related pulmonary infections, especially in patients with severe underlying medical conditions," Roy Baynes, the head of global clinical development and chief medical officer at Merck Research Laboratories, said in a Sept. 11 statement.