Investigational Antibiotic Shows Efficacy, Safety in Late Stage Trial for Uncomplicated Gonorrhea
A phase 3 therapy, zoliflodacin, has shown to be noninferior in a late stage trial. The therapy's manufacturer, Innoviva Speciality Therapeutics, is presenting data at this week's ID Week. The company's CMO David Altarac, MD, offers some insights on the therapy and the timeline for filing the paperwork for prospective FDA approval.
The incidence of STIs has been increasing in the US over the past few years with a disproportionate impact among MSM and transgender women. According to the Centers for Disease Control and Prevention (CDC), an estimated 2.5 million cases of syphilis, gonorrhea, and chlamydia occurred in 2021, which is up from 2.4 million cases in 2020.1
Within STIs, there is a newer virulent multidrug-resistant strain of gonorrhea. Specifically, the penA 60.001 allele in N gonorrhoeae, a genetic variation helps contribute to antibiotic resistance. The penA 60.001 allele alters the bacterial response to cephalosporins.2 This strain of Neisseria gonorrhoeae, ranked among the highest-tier “urgent threats” among the 18 bacteria and fungi on the CDC's 2019 antibiotic resistance threats report.
Although the multidrug-resistant gonorrhea strain has been seen mostly outside the United States, last year 2 cases of this pathogen were confirmed in the US and identified by the Massachusetts Department of Public Health. Massachusetts officials reported that clinicians were able to treat the patients successfully with ceftriaxone. However, this strain of the sexually transmitted infection had reduced susceptibility to 5 antibiotic classes—including cephalosporins, the group of last-resort drugs that includes ceftriaxone.3
As there has been an increase of the STI and the emergence of a multidrug-resistant threat, a need for newer therapies has arisen.
Zoliflodacin a first-in-class oral, single-dose antibiotic for the treatment of uncomplicated gonorrhea is in late stage clinical trials, and has demonstrated efficacy and safety. This phase 3 trial was a global, randomized, controlled study that evaluated the efficacy and safety of zoliflodacin.
The topline data from this trial was previously disclosed at European Society of Clinical Microbiology and Infectious Disease (ESCMID) 2023, which showed that zoliflodacin was non-inferior to a combination of ceftriaxone and azithromycin (5.31%, 95% confidence interval: 1.38-8.65) with urogenital microbiological cure rates of 90.9% (88.1-93.3) and 96.2% (92.9-98.3), respectively, for the microbiological intent-to-treat population. Zoliflodacin had a favorable safety profile with comparable overall number of adverse events between the treatment arms.4
At this week’s ID Week 2024, Innoviva Specialty Therapeutics CMO David Altarac, MD, will be presenting data on zoliflodacin. “The data that we are here to present is for the treatment of gonorrhea, including resistant strains of gonorrhea,” he said in an interview with Contagion.
Altarac says the company is looking at 1 main indication for the therapy. “We are focused on developing the drug for uncomplicated gonorrhea. We believe that, as we've done with other products, a focus on targeted development will advance the efforts towards developing products that have specific focus will be used responsibly, and will hopefully increase the longevity of that product," he said.
With the phase 3 results, the company is planning to file for FDA approval. “We are targeting a new drug application in the United States for the first quarter of next year. Zoliflodacin has been reviewed by the FDA and given both qualified infectious disease product and fast track designation; and therefore, if our new drug application is accepted, we would aim for a priority review,” Altarac said.
