New Haven biotech Melinta Therapeutics said it has started a Phase 3 trial of its drug candidate deloflaxin to test how safe and effective it is compared to an existing treatment at curing gonorrhea.
The U.S. Centers for Disease Control has designated the sexually transmitted disease as an “urgent threat” because drug resistance has whittled down the number of recommended treatments over time to just one — a combination of ceftriaxone and azithromycin.
New antibiotic treatments are needed to stop a four-fold increase in the disease over the next seven years, according to a 2012 CDC report.
Congress signed a law in 2012 called the GAIN Act — co-introduced by Connecticut Senator Richard Blumenthal — which provides incentives for biotech firms to develop antibiotics for drug-resistant pathogens.
If deloflaxin is approved for treatment of uncomplicated gonorrhea, the drug would receive 10 years of extended market exclusivity, which is double the normal timeframe, according to Melinta.
The antibiotic is also in a Phase 3 trial as an experimental treatment for acute bacterial skin infections.
