WASHINGTON — Entasis Therapeutics announced at the World Anti-Microbial Resistance Congress that it has enrolled the first patient in a global phase 3 trial of oral zoliflodacin for the treatment of uncomplicated gonorrhea.
Once easily treated, gonorrhea has become increasingly resistant to available drugs, one of the serious public health consequences of a resurgence of STDs that has been described as “a period of crisis.”
“[It’s] is a huge issue,” Eric Kimble, chief commercial officer for Entasis, told Infectious Disease News. “The CDC has changed its treatment guidelines [for gonorrhea] six times in the last 20 years because of drug resistance. There is a drug that works for gonorrhea, but it is an injection into your muscle and it’s painful.”
The trial will evaluate zoliflodacin in around 600 patients. It is being run and paid for by the Global Antibiotic Research and Development Partnership (GARDP), which will get access to the drug in low- and middle-income countries.
“It’s a perfect partnership because their mission is drug access in places where there is little-to-none or low access,” Manos Perros, PhD, president and chief executive officer of Entasis, told Infectious Disease News. “For us, it is an opportunity to offset some of our costs and an opportunity to make the drug available to people in countries that otherwise would not get access to this drug for a long time. The purpose of drugs is to cure, so we’d like to get this to people who need it.”
Entasis expects results from the trial in 2021, according to Perros. In a small phase 2 trial, a single oral dose of zoliflodacin was shown to be effective at treating uncomplicated urogenital and rectal gonorrhea infections, but was led efficacious in treating pharyngeal gonorrhea.
The CDC currently recommends a dual therapy for gonorrhea of intramuscular ceftriaxone (250 mg) and oral azithromycin (1 g).
“The scary thing about gonorrhea is that [treating it] today is tougher than it was 10 years ago. A decade ago, we had a choice of other oral treatments, but today they no longer work,” Perros said. “Now, we have cases around the world where people are no longer responsive to our last line of defense, which is not a great place to be.”
Kimble suggested zoliflodacin could be one answer to this problem.
“This is a drug that, because it’s oral, really has the chance to change the course of this disease,” Kimble said. “Not only can patients in the office take this drug, but there are regulations in the United States which allow for patients to take an oral dose home with them to give their partner.” – by Caitlyn Stulpin
Taylor SN, et al. N Engl J Med. 2019;doi:10.1056./NEJMoa1706988.
Disclosures: Kimble and Perros are employees of Entasis Therapeutics.