SHANGHAI, Nov. 22, 2024 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that data on its critical-care, anti-infective product, eravacycline (XERAVA®), was recently presented in Los Angeles, California at IDWeek 2024. Among the findings, two in vitro study results further demonstrated the broad and consistent antimicrobial activity of eravacycline.
The first study evaluated the in vitro antimicrobial activity of eravacycline against Carbapenem-resistant Acinetobacter baumannii (CRAB), using broth microdilution, MIC test strip (MTS), and disk diffusion methods to evaluate the susceptibility of eravacycline against 587 strains of CRAB. Using the recently approved, ChinaCAST breakpoint of 1 µg/mL the results showed a high susceptibility rate of eravacycline against CRAB, with a susceptibility rate of 98.13% (576/587) detected by broth microdilution, 97.96% (575/587) and 97.61% (573/587) susceptibility rates detected by MTS and disk diffusion methods, respectively. The results of the three antimicrobial susceptibility test (AST) methods were consistent. The study results demonstrated the high percent susceptibility of eravacycline to CRAB in vitro, and the consistency across the three AST methods underscored the reliability and stability of eravacycline’s susceptibility results in clinical microbiology settings. Xerava® is not indicated for infections caused by Acinetobacter spp. including CRAB. Additional clinical data are necessary to establish efficacy.
The second study evaluated the in vitro activity of eravacycline against 23,127 global clinical isolates of major Gram-positive and Gram-negative bacteria, including drug-resistant strains collected from various regions such as Asia, Europe, and North America from 2018 to 2022. The results showed that since its approval in 2018, eravacycline has consistently maintained a high level of susceptibility against clinically relevant pathogens across diverse geographic regions and infection sites. This stable in vitro antimicrobial activity over the past five years supports eravacycline’s use in treating complicated intra-abdominal infections caused by both Gram-negative and Gram-positive bacteria.
"The in vitro study results for eravacycline presented at IDWeek further underscore its broad-spectrum antibacterial coverage and potent activity as the world’s first and only new class of antibacterial—fluorocyclines. This reinforces its clinical potential in treating infections caused by multidrug-resistant pathogens," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "With the global threat of antimicrobial resistance on the rise, the latest findings on eravacycline are encouraging. We are committed to collaborating with medical experts across specialties to further explore and promote its rational use, ensuring that eravacycline can effectively support more patients affected by complex infections."
XERAVA® for injection is indicated for the treatment of complicated intra-abdominal infections. The in vitro antimicrobial susceptibility studies data should not be directly used to predict clinical efficacy.
Infectious Disease (ID) Week is a top academic global medical congress that attracts nearly ten thousand experts and scholars annually to share and exchange the latest research results and diagnostic and treatment progress. XERAVA® was approved by the National Medical Products Administration (NMPA) of China in March 2023 and commercially launched in July. Its antibacterial spectrum covers a wide range of clinically relevant bacteria, including Gram-negative, Gram-positive, anaerobic bacteria. Eravacycline has been included in several clinical guidelines and expert consensuses, such as the 2023 edition of China’s "Diagnosis, Treatment, and Prevention Guidelines for Carbapenem-Resistant Gram-Negative Organisms (CRO) Infections."
In March 2024, the World Health Organization (WHO) updated its list of "Medically Important Antimicrobials" (MIA). Based on the novel modification of the tetracycline side chain, which significantly changes its resistance mechanisms, the WHO categorized fluorocycline as a new class of antimicrobial drugs, with eravacycline as the only drug in this class. In August 2024, the "Comprehensive Evaluation Project on the Clinical Application of Eravacycline " initiated and hosted by the National Health Commission Expert Committee on Clinical Application and Drug Resistance Evaluation of Antibiotics released an interim report, which showed that the overall effectiveness of eravacycline at 3 days of treatment was as high as 90.9%, and the overall treatment effectiveness at the end of treatment was 89.0%. Since its commercialization, XERAVA® has benefited thousands of patients.
About XERAVA® (eravacycline)
XERAVA® (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative, Gram-positive and anaerobic pathogens, including those 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, EU, UK, Singapore, mainland China, Hong Kong, and Taiwan. XERAVA® was licensed to Everest by Tetraphase Pharmaceuticals, Inc., an affiliate of Innoviva Specialty Therapeutics, Inc.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company’s core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.
About Innoviva Specialty Therapeutics, Inc.
Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ product, through its affiliate, Entasis Therapeutics Inc., include XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex. For more information about Innoviva Specialty Therapeutics, please visit here.
Forward-Looking Statements:
This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.
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