NEW YORK, April 4 — Paratek Pharmaceuticals Inc said yesterday its experimental lead antibiotic succeeded in a second late-stage study, bringing it one step closer to applying for marketing approvals in the United States and Europe.
The drug, omadacycline, belongs to a new class of tetracycline antibiotics, which were launched in the 1950s to treat skin, respiratory and other infections.
Paratek’s omadacycline, which was being tested against an existing antibiotic called moxifloxacin, met the main goals in a late-stage study in patients with community-acquired bacterial pneumonia (CABP), which is considered a leading cause of death due to infection.
In the 774-patient trial, there were twelve deaths — eight in those that were given omadacycline and four in the moxifloxacin arm. None of the fatalities were considered drug related, Chief Executive Officer Michael Bigham told Reuters.
Omadacycline, which is being evaluated for oral and intravenous therapy, has already cleared a separate late-stage study in acute bacterial skin and skin structure infections (ABSSSI).
The infection, often treated with intravenous therapies, involves deep tissue or is associated with an underlying disease such as diabetes. ABSSSI leads to more than 5 million hospitalizations each year in the United States and Western Europe.
The drug is also being tested in a third late-stage study for serious skin infection.
Paratek plans to submit US and European marketing applications for the drug in 2018.
The drug has already been granted qualified infectious disease product designation and fast-track status by the US Food and Drug Administration that may help secure approval for the treatment as early as the end of next year, the CEO said.
Bigham did not disclose the company’s pricing strategy but pointed to Pfizer Inc’s recently approved antibiotic Zyvox, which costs about US$3000 (RM13,294) for a 10-day course of treatment as a benchmark.
Separately, Paratek and Allergan Plc announced positive late-stage acne data from two trials testing their antibiotic, sarecycline, last week.
The need for new antibiotics is mounting as patients build up resistance to older therapies.
But the pace of development has lagged as they are not as profitable as other treatments — such as cancer drugs — and because aggressive marketing tactics only serve to exacerbate their overuse.
Rival drug developer Tetraphase Pharmaceuticals Inc’s antibiotic, eravacycline, is also being studied in late-stage trial and belongs to the tetracycline class of antibiotics. — Reuters