Slide 1: Zoliflodacin Phase 3 clinical trial topline data
Zoliflodacin Phase 3 clinical trial topline data November 2, 2023
Slide 2: Top line summary: positive zoliflodacin Phase 3 results
Top line summary: positive zoliflodacin Phase 3 results 1 – WHO global antimicrobial resistance suveillance. Lancet Microbe 2021; 2: e627 – 36 2 – Lancet 2023; 9: e332 - 33 2 • An estimated 82 million patients contract gonorrhea each year 1 , with rising rates of resistance to standard of care regim
Slide 3: Zoliflodacin Phase 3 registration study design
Zoliflodacin Phase 3 registration study design 3 The zoliflodacin pivotal Phase 3 registration trial was conducted to evaluate the efficacy of a single 3g oral dose of zoliflodacin in treatment of uncomplicated gonorrhea compared to treatment with intramuscular injection of ceftriaxone and oral azit
Slide 4: Study enrollment
Study enrollment 4 1011 patients were initially screened, with 927 randomized and dosed. The majority of participants (744) presented with urogenital infections, followed by rectal infections (114) and pharyngeal infections (81). Participants could be in more than one group. Overall, the trial parti
Slide 5: The primary endpoint was achieved
The primary endpoint was achieved A high microbiological cure rate (>90% in both arms) was observed 5 Microbiological cure rate at test of cure visit Zoliflodacin met the primary efficacy endpoint and was non - inferior to the comparator (point estimate 5.3% (95% confidence interval (CI): 1.4%, 8.7%
Slide 6: Key secondary analyses showed comparable results in comparison to comparator
Key secondary analyses showed comparable results in comparison to ceftriaxone and azithromycin 6 Microbiological cure rate at test of cure visit Key secondary analysis included participants with pharyngeal and rectal gonorrhea. Historical rates of cure for these populations have been lower than thos
Slide 7: Favorable safety and tolerability profile in this study
Favorable safety and tolerability profile in this study 7 In this study, zoliflodacin was safe and generally well - tolerated The overall rate of adverse events was comparable between the two arms The majority of adverse events were mild to moderate There were no discontinuations reported due to adv