Everest Reports on P1 Trial of Taniborbactam in Combo with Cefepime in China
Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced on September 15 top-line results from its Phase 1 clinical trial in China of taniborbactam (formerly VNRX-5133) in combination with cefepime for the treatment of infections caused by multi-drug resistant (MDR) pathogens. The study met its primary objective, demonstrating that the cefepime-taniborbactam combination treatment was safe and well tolerated among healthy Chinese volunteers with key pharmacokinetics parameters indicating no detectable signal of ethnic differences.
“China continues to face the challenges of high rates of infection caused by MDR pathogens. Taniborbactam’s novel β-lactamase inhibitor mechanism of action, in combination with cefepime, an antibiotic that is part of the current and established standards of care, has the potential to treat a broader range of MDR pathogens, in particular, those infections caused by carbapenem resistant Gram-negative pathogens, helping to address a unique challenge in the region,” said Sunny Zhu, Chief Medical Officer for Infectious Diseases at Everest Medicines. “We look forward to advancing the clinical development of cefepime-taniborbactam in this important disease area as we work to bring a potentially best-in-class therapy to patients globally.”
“The events of this year reinforce a sense of urgency in our efforts to address severe infectious diseases,” said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. “We thank the patients, their families and all the healthcare providers for their commitment to helping us bring innovative antibiotics to all the patients in need.”
Everest Medicines is also evaluating cefepime-taniborbactam in a global pivotal Phase 3 clinical trial for the treatment of complicated urinary tract infection (cUTI) in collaboration with, and sponsored by, Venatorx Pharmaceuticals. Under an exclusive licensing agreement with Venatorx Pharmaceuticals, Everest Medicines has the rights to develop and commercialize cefepime-taniborbactam in Mainland China, Hong Kong, Macau, Taiwan, South Korea, Indonesia, Malaysia, Philippines, Thailand, Singapore and Vietnam.