New Haven-based Melinta Therapeutics, a privately held company developing antibiotics to treat serious bacterial infections, announced this week that it has submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration for approval of IV and oral Baxdela (delafloxacin) to treat patients with acute bacterial skin and skin structure infections.
Baxdela is an investigational antibiotic that aims to treat serious bacterial infections, including methicillin-resistant Staphylococcus aureus, or MRSA.
The NDAs follow two successful Phase 3 studies of Baxdela and the company, among those featured over the summer in a Hartford Business Journal bioscience series, is hoping to get final FDA approval for the drug in mid-2017.
Because the drug is designated as a qualified infectious disease product by the FDA, it’s on an accelerated review clock and Melinta expects a decision in mid-June, Dr. Eugene Sun, the company’s CEO, said in an interview this week.
“Within a few weeks of approval, we’ll be selling,” Sun said.
That will be a milestone for a company that was founded in 2001.
“It’s been hanging in there all these years, which is an accomplishment in and of itself to survive as a biotech company all these years, but we hope that we are now starting a new phase where we will have revenue and can be self-sustaining at some point,” Sun said. “And what’s coming behind it we think is actually even more interesting,” he added, referring to new drugs in development, including one in Melinta’s ESKAPE program.
Each letter in ESKAPE stands for bacteria with multidrug resistance features and Melinta is working on one antibiotic, in a completely new class of drugs, to treat all six superbugs or bacteria in ESKAPE, which cause various ailments ranging from pneumonia and urinary-tract infections to intra-abdominal and blood-stream infections.
“We’d like to have a continual stream of new antibiotics coming out of our shop because the fight never ends,” Sun said. “Bacteria are always fighting, so they will always figure out a way — there will be resistance to every antibiotic at some point, and so it is the one therapeutic area that actually can never go away, so we’re in it for the long haul.”
Melinta also has begun a Phase 3 study to test Baxdela for treating bacterial pneumonia. It also plans to study the drug’s effect on treating complicated urinary tract infections.
For now, though, Melinta can only promote its results for Baxdela on serious skin infections and Sun said Baxdela’s IV and oral formulation is a big advantage.
“Having the option of an oral formulation allows doctors and hospitals to rapidly let patients transition to completing their therapy outside of the hospital, which is great for the patient to be in their own home environment, it saves everybody money … so that’s the goal,” he said. “We actually expect a significant amount of use of the oral form of the antibiotic.”
