Everest Medicines Announces Top-line Results from Phase 1 Clinical Trial of Taniborbactam in Combination with Cefepime in China
Shanghai, China, September 15, 2020 – 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, today announced 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.
About Taniborbactam (VNRX-5133)
Taniborbactam, formerly known as VNRX-5133, is a parenteral, potentially best-in-class, cyclic boronate compound that inhibits both serine- and metallo-β-lactamases. Combined with cefepime, a fourth generation cephalosporin antibiotic, taniborbactam drives antimicrobial activity against Gram-negative bacteria that have acquired MDR via classes A, B, C and D β-lactamase expression. Taniborbactam is the only known β-lactamase inhibitor in advanced clinical development that blocks class B carbapenemases. In 2019, Everest Medicines and licensing partner Venatorx Pharmaceuticals, a private pharmaceutical company headquartered in the United States that is focused on the discovery and development of novel anti-infectives to treat multi-drug-resistant bacterial infections and hard-to-treat viral infections, initiated a global Phase 3 clinical trial for patients with cUTI. For more information, please visit www.venatorx.com.
About Complicated Urinary Tract Infection
A cUTI occurs in an individual in whom factors related to the host (e.g. underlying diabetes or immunosuppression) or specific anatomical or functional abnormalities related to the urinary tract (e.g., obstruction) are believed to result in an infection that will be more difficult to eradicate than an uncomplicated infection. Urinary tract infection (UTI) is one of the most common bacterial infection in adults. UTI is also one of the most frequent hospital acquired infection.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com .
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