The antibiotic omadacycline has displayed an ability to fight treatment-resistant respiratory, skin and urinary-tract bacteria in preclinical-trial studies, according to its maker, Paratek’s Pharmaceuticals.
The company presented the results, which include omadacycline’s ability to fight drug-resistant pneumonia, at the American Society for Microbiology’s Microbe convention in New Orleans, June 1-5.
Omadacycline was effective against methicillin-resistant Staphylococcus aureus as well as strains resistant to tetracyclines, fluoroquinolones, macrolides, and lincosamides, Paratek said. It also showed strength against another respiratory bacteria, Streptococcus pneumoniae, including strains resistant to penicillin, tetracycline and macrolide, the company said.
And it displayed punch against Haemophilus influenza and Moraxella catarrhalis bacteria.
Researchers evaluated omadacycline in a laboratory against the two broad classes of bacteria, Gram-negative and Gram-positve. Gram-negative bacteria are generally more drug-resistant.
The samples were collected from patients with different infections at medical facilities in the United States, Europe and Israel that took part in the 2016 SENTRY Antimicrobial Surveillance Program.
Paratek bases its therapies on tetracycline chemistry. If regulators approve omadacycline, it will likely become the first aminomethylcycline – a new class of tetracycline – to be used against Gram-Gram-negative, Gram-positive and another category of pathogens known as atypical bacteria.
“Omadacycline continues to show significant clinical promise against resistant pathogens such as MRSA [methicillin-resistant Staphylococcus aureus] and resistant strains of Streptococcus pneumoniae,” Paratek’s president, Dr. Evan Loh, said in a press release. “These findings are consistent with the clinical success we have seen with omadacycline to date in ABSSSI [acute bacterial skin and skin structure infections] and community-acquired bacterial pneumonia.” Community-acquired pneumonia develops outside a hospital or other care facility.
“Importantly, this study also contributes to our growing body of knowledge of omadacycline’s in vitro [laboratory] activity against pathogens responsible for UTI [urinary tract infections], including E. coli,” Loh said. “We believe there is a significant clinical unmet need for new oral, broad-spectrum antibiotic agents for the treatment of UTI, and we are committed to advancing our clinical development program in this population.”
Paratek just wrapped up a Phase 3 clinical trial (NCT02531438) that compared omadacycline and Moxifloxacin as treatments for community-acquired pneumonia. It is still evaluating the results.
Omadacycline has received two U.S. Federal Drug Administration designations that will help accelerate its approval process. One is an infectious disease product designation, and the other fast track status.
Paratek plans to submit a new drug application to the agency in the first quarter of 2018, and a similar application to the European Medicines Agency after that.
