Everest Medicines Completes Enrollment of Phase 3 Clinical Trial of Xerava™ (eravacycline) for the Treatment of Complicated Intra-Abdominal Infections in China
· Top-line data from China Phase 3 trial expected in the fourth quarter of 2020
Shanghai, China, August 28, 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 that it completed patient enrollment for its Phase 3 clinical trial of eravacycline (marketed as Xerava™ in the US and EU) for the treatment of complicated intra-abdominal infections (cIAI) in patients in China.
Xerava is a novel, fully synthetic, broad-spectrum parenteral antibiotic of the tetracycline class. In two previous global pivotal studies, Xerava was well tolerated in people with cIAI and demonstrated statistical non-inferiority to two widely used comparators – ertapenem and meropenem. These two studies led to Xerava’s approvals in US, EU and Singapore. Top-line results from this China trial are expected in the fourth quarter of 2020 and plan to support Everest Medicines’ New Drug Application filing in China.
“Our first China Phase 3 trial is an important milestone for Everest Medicines and reinforces our commitment to accelerate the development and commercialization of our broad pipeline of novel drug candidates to address unmet medical needs in Greater China and other parts of Asia,” said Sunny Zhu, Chief Medical Officer for Infectious Diseases at Everest Medicines. “Xerava represents an important potential new treatment option for the management of complicated infections, especially among drug resistant pathogens.”
“As we work to complete this registrational trial and move towards potential approval in China, we are grateful to the many researchers, healthcare providers and patients who have participated in the study, even throughout the COVID-19 pandemic, enabling us to rapidly advance important medical innovations for patients in even the most difficult environments,” said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines.
Under the licensing agreement with Tetraphase Pharmaceuticals , Everest Medicines has exclusive rights to develop and commercialize Xerava in Greater China, South Korea, and the key markets of South East Asia, including Indonesia, Malaysia, Philippines, Thailand, Singapore and Vietnam. Xerava is approved for the treatment of cIAI in adults by the Health Science Authority (HSA) in Singapore in April 2020. Xerava is currently approved for the treatment of cIAI in the US and EU.
About Complicated Intra-Abdominal Infections
Complicated intra-abdominal infections (cIAI) are a type of major hospital- or community-acquired infection which extend beyond the source organ into the peritoneal space and can result from perforation of or damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. cIAI is caused by different bacterial pathogens, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. In 2018, there were 2.9 million cIAI patients in China, with increasing rates of infections caused by drug-resistant bacteria, which limits the effectiveness of currently available antibiotics.
About Xerava™ (eravacycline)
Xerava™ is a novel, fully synthetic, broad-spectrum parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Xerava is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US and EU. The Company received approval in Singapore for eravacycline in cIAI in April 2020. The Company is conducting a Phase 3 clinical trial in China for cIAI to support regulatory approval to launch in China. Xerava was licensed from Tetraphase Pharmaceuticals. For more information, please visit https://www.xerava.com/ .
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. Currently, four assets are in clinical trials designed for registration in China and two additional assets will start registrational trials in 2020. For more information, please visit its website at www.everestmedicines.com .
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