{"id":16265,"date":"2024-12-02T18:06:47","date_gmt":"2024-12-02T10:06:47","guid":{"rendered":"https:\/\/flcube.com\/?p=16265"},"modified":"2024-12-02T18:06:51","modified_gmt":"2024-12-02T10:06:51","slug":"shanghai-micurxs-mrx-4-contezolid-meets-primary-endpoint-in-phase-iii-cssti-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=16265","title":{"rendered":"Shanghai MicuRx’s MRX-4\/Contezolid Meets Primary Endpoint in Phase III cSSTI Study"},"content":{"rendered":"\n

Shanghai MicuRx Pharmaceutical Co., Ltd. (SHA: 688373<\/a>) has announced that its Phase III study for MRX-4, transitioning to oral contezolid tablets for the treatment of adult patients with complex skin and soft tissue infections (cSSTI), has successfully met its primary efficacy endpoint.<\/p>\n\n\n\n

Phase III Study Design and Results<\/strong>
The multi-center, randomized, double-blind double dummy Phase III study evaluated the safety and efficacy of MRX-4 transitioning to contezolid versus intravenous linezolid in cSSTI. The results indicated that the intravenous infusion of MRX-4 at 2000 mg for the first dose, followed by 1000 mg (with subsequent oral administration of 800 mg Contezolid tablets, referred to as “MRX-4\/Contezolid”), administered every 12 hours for a duration of 7-14 days, demonstrated good clinical and microbiological efficacy. Statistical analysis confirmed that MRX-4\/Contezolid were non-inferior to the linezolid group in terms of clinical efficacy, achieving the primary endpoint of the study. In terms of safety, the study showed that the MRX-4\/Contezolid regimen had good safety and tolerability, with no adverse events related to the study drug leading to treatment discontinuation or withdrawal from the trial.<\/p>\n\n\n\n

Contezolid and MRX-4 Background<\/strong>
Contezolid was approved in China in June 2021 for the treatment of complex skin and soft tissue infections. MRX-4, the pro-drug version of contezolid (MRX-1), is a potent oxazolidinone antibiotic against Gram-positive pathogens. The MRX-4\/contezolid combination has been previously approved for use as a sequential treatment for infections caused by drug-resistant Gram-positive bacteria in multiple countries, as well as for diabetic foot infection.<\/p>\n\n\n\n

Plans for New Drug Application (NDA)<\/strong>
With the positive Phase III data, MicuRx plans to complete communications with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and submit a New Drug Application (NDA) for the MRX-4\/Contezolid combination.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Shanghai MicuRx Pharmaceutical Co., Ltd. (SHA: 688373) has announced that its Phase III study for…<\/p>\n","protected":false},"author":1,"featured_media":16266,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[17,279,1102],"class_list":["post-16265","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-results","tag-micurx-pharmaceuticals","tag-sha-688373"],"yoast_head":"\nShanghai MicuRx's MRX-4\/Contezolid Meets Primary Endpoint in Phase III cSSTI Study - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Shanghai MicuRx Pharmaceutical Co., Ltd. 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