[Translation] A multicenter, randomized, double-blind, double-dummy phase III clinical trial to evaluate the efficacy and safety of intravenous infusion of MRX-4 to oral contezolid tablets in the treatment of adult patients with complicated skin and soft tissue infections, with linezolid intravenous infusion to oral administration as a control

主要目的：评价静脉输注MRX-4转口服康替唑胺片治疗成人复杂性皮肤和软组织感染的临床疗效和安全性。次要目的：①评价静脉输注MRX-4转口服康替唑胺片治疗成人复杂性皮肤和软组织感染的微生物学疗效。 ②明确成人复杂性皮肤和软组织感染患者静脉输注MRX-4转口服康替唑胺片的药代动力学特征。

[Translation]

Primary objective: To evaluate the clinical efficacy and safety of intravenous infusion of MRX-4 to oral contezolid tablets in the treatment of complicated skin and soft tissue infections in adults. Secondary objectives: ① To evaluate the microbiological efficacy of intravenous infusion of MRX-4 to oral contezolid tablets in the treatment of complicated skin and soft tissue infections in adults. ② To clarify the pharmacokinetic characteristics of intravenous infusion of MRX-4 to oral contezolid tablets in patients with complicated skin and soft tissue infections in adults.

Start Date04 Aug 2023

Sponsor / Collaborator

Shanghai MicuRx Pharmaceutical Co., Ltd.

NCT05369052 / RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)

This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.

Start Date03 May 2022

Sponsor / Collaborator

MicuRx Pharmaceuticals, Inc.

CTR20190111 / CompletedPhase 1

考察健康中国受试者静脉输注和口服MRX-4后的安全性和药代动力学特征的随机、双盲、安慰剂对照的I期临床试验

[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial to investigate the safety and pharmacokinetic characteristics of MRX-4 after intravenous and oral administration in healthy Chinese subjects

评价静脉输注及口服MRX-4在健康中国受试者中的安全性、耐受性和药代动力学特征。

[Translation]

To evaluate the safety, tolerability, and pharmacokinetic characteristics of intravenous and oral MRX-4 in healthy Chinese subjects.

Start Date11 Sep 2020

Sponsor / Collaborator

Mengke Medical Technology (Shanghai) Co Ltd

[+1]

100 Clinical Results associated with Contezolid Acefosamil

100 Translational Medicine associated with Contezolid Acefosamil

100 Patents (Medical) associated with Contezolid Acefosamil

Literatures (Medical) associated with Contezolid Acefosamil

08 Oct 2024·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Erratum for Yang et al., “A phase I study of the safety, tolerability, and pharmacokinetics of contezolid acefosamil after intravenous and oral administration in healthy Chinese subjects”

Article

Author: Li, Xin ; Cao, Guoying ; Jin, Yi ; Wu, Jufang ; Wang, Hailin ; Yuan, Hong ; Zhang, Jing ; Yang, Haijing ; Wang, Jingjing ; Li, Size ; Liang, Hong ; Hu, Yingying ; Yang, Huahui

01 May 2024·Journal of applied toxicology : JAT

Preclinical toxicity evaluation of novel antibacterial contezolid acefosamil in rats and dogs

Article

Author: Gordeev, Mikhail F ; Yuan, Hong ; Li, Zhengyao ; Wang, Wen

Abstract:

Contezolid acefosamil (CZA) is an intravenous prodrug of oxazolidinone antibiotic contezolid (CZD). It is being developed to treat infections due to Gram‐positive bacteria including multidrug‐resistant pathogens, while addressing myelosuppression and neurotoxicity limitations associated with long‐term use of this class of antibiotics. In vivo, CZA is rapidly deacylated into its first metabolite MRX‐1352, which is then dephosphorylated to release active drug CZD. Four‐week repeat‐dose toxicity studies of intravenous CZA were conducted in Sprague–Dawley rats (40, 80, and 160/120 mg/kg/dose twice a day [BID]) and beagle dogs (25, 50, and 100/75 mg/kg/dose BID). The high doses administered to both rats and dogs were adjusted due to adverse effects including decreased body weight and food consumption. Additionally, a dose‐dependent transient reduction in erythrocyte levels was recorded at the end of dosing phase. Importantly, no myelosuppressive reduction in platelet counts was observed, in contrast to the myelosuppression documented for standard‐of‐care oxazolidinone linezolid. The no‐observed‐adverse‐effect level (NOAEL) of CZA was 80 and 25 mg/kg/dose BID in rats and dogs, respectively. Separately, 3‐month neuropathological evaluation in Long–Evans rats (25, 37.5, and 50 mg/kg/dose, oral CZA, BID) demonstrated no neurotoxicity in the central, peripheral, and optical neurological systems. Toxicokinetic data from these studies revealed that CZD exposures at NOAELs were higher than or comparable with that for the intended clinical dose. These results confirm the favorable safety profile for CZA and support its clinical evaluation for long‐term therapy of persistent Gram‐positive infections, beyond the application for earlier oxazolidinones.

03 Apr 2024·Antimicrobial agents and chemotherapy

Population pharmacokinetic rationale for intravenous contezolid acefosamil followed by oral contezolid dosage regimens

Article

Author: Stryjewski, Martin E. ; Fang, Edward ; Hafkin, Barry ; Bulitta, Jürgen B. ; Atiee, George J. ; Stark, Jeffrey G. ; Wang, Wen

ABSTRACT:

Contezolid is a novel oxazolidinone antibiotic with a promising safety profile. Oral contezolid and its intravenous (IV) prodrug contezolid acefosamil (CZA) are in development for treatment of diabetic foot and acute bacterial skin and skin structure infections (ABSSSI). The prodrug CZA is converted to active contezolid via intermediate MRX-1352. This study aimed to provide the pharmacokinetic rationale for safe, effective, and flexible dosage regimens with initial IV CZA followed by oral contezolid. We simultaneously modeled plasma concentrations from 110 healthy volunteers and 74 phase 2 patients with ABSSSI via population pharmacokinetics (using the importance sampling estimation algorithm), and optimized dosage regimens by Monte Carlo simulations. This included data on MRX-1352, contezolid, and its metabolite MRX-1320 from 66 healthy volunteers receiving intravenous CZA (150–2400 mg) for up to 28 days, and 74 patients receiving oral contezolid [800 mg every 12 h (q12h)] for 10 days. The apparent total clearance for 800 mg oral contezolid with food was 16.0 L/h (23.4% coefficient of variation) in healthy volunteers and 17.7 L/h (53.8%) in patients. CZA was rapidly converted to MRX-1352, which subsequently transformed to contezolid. The proposed dosage regimen used an IV CZA 2000 mg loading dose with 1000 mg IV CZA q12h as maintenance dose(s), followed by 800 mg oral contezolid q12h (with food). During each 24-h period, Monte Carlo simulations predicted this regimen to achieve consistent areas under the curve of 91.9 mg·h/L (range: 76.3–106 mg·h/L) under all scenarios. Thus, this regimen was predicted to reliably achieve efficacious contezolid exposures independent of timing of switch from IV CZA to oral contezolid.

IMPORTANCE:

This study provides the population pharmacokinetic rationale for the dosage regimen of the intravenous (IV) prodrug contezolid acefosamil (CZA) followed by oral contezolid. We developed the first integrated population model for the pharmacokinetics of the MRX-1352 intermediate prodrug, active contezolid, and its main metabolite MRX-1320 based on data from three clinical studies in healthy volunteers and phase 2 patients. The proposed regimen was predicted to reliably achieve efficacious contezolid exposures independent of timing of switch from IV CZA to oral contezolid.

News (Medical) associated with Contezolid Acefosamil

29 Nov 2024

·www.prnewswire.com

MicuRx: Successfully Completes Phase III Clinical Trial of MRX-4 for Injection in China

SHANGHAI, Nov. 29, 2024 /PRNewswire/ -- Recently, Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx", 688373.SH) announced the successful completion of its Phase III clinical trial of MRX-4 for injection transitioning to oral Contezolid tablets for the treatment of adult patients with complex skin and soft tissue infections (cSSTI) in China. The trial achieved its primary efficacy endpoint, and the company will actively move forward with the New Drug Application (NDA) process of MRX-4 for injection in China. Clinical Trial Results and Key Findings This clinical trial was designed to evaluate MRX-4 for injection transitioning to oral Contezolid tablets in comparison to intravenous Linezolid for treating adult patients with cSSTI (including those caused by methicillin-resistant Staphylococcus aureus (MRSA)). The results of the study showed that the intravenous infusion of MRX-4 at 2000 mg for the first dose, followed by 1000 mg (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 showed that MRX-4/Contezolid were non-inferior to the Linezolid group in terms of clinical efficacy, achieving the primary endpoint of the study. Regarding safety, the study showed that the MRX-4/Contezolid regimen had good safety and tolerability. No adverse events related to the study drug led to treatment discontinuation or withdrawal from the trial. The clinical adverse events related to the study drug were primarily gastrointestinal reactions, including nausea and vomiting. Laboratory abnormalities related to the study drug were elevations in liver enzymes. Most of them were mild and transient. Additionally, the incidence of platelet reduction and hematological adverse events in the MRX-4/Contezolid group was significantly lower than in the Linezolid group. Impact of the Study and Future Plans The success of this clinical trial is expected to enable MRX-4 for injection to be approved and commercialized in China for the first time. After being launched, it can provide more medication convenience for critically ill patients and patients who are not suitable for oral administration, meeting clinical needs and significantly boosting the company's revenue from the Chinese market. This success lays a solid foundation for the drug's future commercialization, and the company will continue to invest in this project, with plans to complete communications with the CDE, submit the NDA, and undergo technical reviews and site inspections. Additionally, based on the company's lifecycle management plan for oral Contezolid tablets and MRX-4 for injection, MicuRx is planning to conduct a Phase III clinical trial in China for MRX-4/Contezolid tablets in the treatment of infections caused by drug-resistant Gram-positive bacteria at various sites. This trial aims to expand the potential indications and enhance the social and commercial value of the drug. Furthermore, the international multicenter Phase III clinical trial for MRX-4/Contezolid tablets in the treatment of diabetic foot infections will continue, with China being one of the participating countries. About Contezolid Tablets and MRX-4 Contezolid tablets and MRX-4 are novel oxazolidinone-class antibacterial drugs developed by MicuRx, with global intellectual property rights. Contezolid tablets (400 mg) were approved by the NMPA in China on June 1, 2021, for the treatment of cSSTI, marking the first approval worldwide. MRX-4 for injection is a water-soluble prodrug of contezolid, developed by the company based on an in-depth analysis and scientific investigation of contezolid. MRX-4 for injection can be converted into the active ingredient contezolid in the human body, expanding the usage scenarios. SOURCE MicuRx Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalNDAClinical Result

22 Sep 2023

·www.prnewswire.com

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

FOSTER CITY, Calif., Sept. 22, 2023 /PRNewswire/ -- MicuRx Pharmaceuticals, Inc., a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and the Fast Track Designation under the Generating Antibiotic Incentives Now (GAIN) Act for contezolid (MRX-I) tablet and contezolid acefosamil (MRX-4) tablet and intravenous as novel new oxazolidinone antibiotics for the treatment of moderate to severe diabetic foot infection (DFI) without concomitant osteomyelitis. Oral contezolid and intravenous (IV) contezolid acefosamil are currently being studied in a global Phase 3 clinical trial in treatment of patients with DFI. QIDP designation provides both products with a five-year extension of data exclusivity provisions and eligibility for Priority Review of its New Drug Application (NDA) for DFI once submitted. Both products were previously granted QIDP designation and Fast Track status in 2018 for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Continue Reading MicuRx Pharmaceuticals The QIDP and Fast Track designations were created as part of the Food and Drug Administration Safety and Innovation Act, FDASIA (June 2012), Title VIII – Generating Antibiotic Incentives Now (GAIN) Act, to encourage development of treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections. "We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. Approximately 18.6 million people worldwide are affected by a diabetic foot ulcer each year, including 1.6 million people in the United States. About half of ulcers become infected and can lead to significant morbidity and mortality. When under- or untreated, severe DFI infections can progress to osteomyelitis (infection of the bone), significant tissue and bone damage, and result in amputation of the infected limb in 17% of cases of diabetic ulcers.[1] Prevalence of DFI is increasing as the prevalence of diabetes increases worldwide. With excellent microbiological activity against common Gram-positive bacteria, contezolid and contezolid acefosamil are well positioned to benefit DFI patients, particularly due to methicillin-resistant Staphylococcus aureus (MRSA). Staphylococcus sp. are the most common bacteria causing DFI, and the rate of methicillin resistance in S. aureus remains at high levels ranging from 25-65% with wide regional variation in the USA. Given the difficulty and significance of diabetic foot infections, patients are treated for 2-6 weeks or longer. Many products effective against MRSA are often available only in IV formulations and can cause significant toxicities. "Contezolid and contezolid acefosamil have shown an excellent safety profile, particularly for reduced potential for hematological toxicities, in our clinical studies and after two years of real-world data on the market in China", said Dr Regis Vilchez, Chief Medical Officer at MicuRx. "We believe that MicuRx can offer an important new choice for DFI treatment with flexibility of oral and IV formulations." For more information, contact [email protected]. About MicuRx Pharmaceuticals, Inc. MicuRx is a biopharmaceutical company focusing on novel therapeutics for infectious diseases. With global independent intellectual property and competitiveness, we are committed to the discovery, development, and commercialization of innovative drugs for unmet medical needs. Since the company was founded in 2007, MicuRx has adhered to the principle of "Better therapy through superior medicine", focusing on the increasingly serious problem of global antimicrobial resistance. For more information, please visit the official website of MicuRx Pharmaceuticals at . About Contezolid and Contezolid Acefosamil Contezolid tablets and MRX-4 are innovative antimicrobial drugs with global intellectual property rights developed by MicuRx Pharmaceuticals. Contezolid tablets was approved by the National Medical Products Administration (NMPA) on June 1, 2021 in China, for the treatment of complicated skin and soft tissue infections, marking the first global approval of this drug. MRX-4, developed based on Contezolid tablets, serves as a prodrug of Contezolid. About Diabetic Foot Infections Approximately 18.6 million people worldwide are affected by a diabetic foot ulcer each year, including 1.6 million people in the United States. Neurological, vascular, and biomechanical factors contribute to diabetic foot ulceration. Approximately 50% to 60% of ulcers become infected, with up to 20% of these requiring hospitalization. Between 15-20% of moderate-to-severe infections lead to lower extremity amputations. [1] Every year, more than 1 million people with diabetes lose at least a part of their leg as a consequence of the complications of diabetes. This translates into the estimate that every 20 seconds a lower limb is lost to diabetes somewhere in the world.[2] The direct costs of treating diabetic foot ulcers in the USA are estimated to be $9 billion to $13 billion annually. The 5-year mortality rate for individuals with a diabetic foot ulcer is approximately 30%, exceeding 70% for those with a major amputation.[1] [1] Armstrong et al, JAMA 2023. Diabetic Foot Ulcers - A Review. JAMA. 2023;330(1):62-75. doi:10.1001/jama.2023.10578 [2] Bakker et al, Diabetes Metabolism Research Review 2015. The 2015 IWGDF guidance documents on prevention and management of foot problems in diabetes: development of an evidence-based global consensus. SOURCE MicuRx Pharmaceuticals

Fast TrackPhase 3Drug ApprovalQualified Infectious Disease Product

24 May 2021

·www.globenewswire.com

Acute Bacterial Skin and Skin Structure Infections Pipeline Featuring Plethora of Emerging Drugs, Key Companies

Los Angeles, USA, May 24, 2021 (GLOBE NEWSWIRE) -- Acute Bacterial Skin and Skin Structure Infections Pipeline Featuring Plethora of Emerging Drugs, Key Companies Ceftobiprole Medocaril under Phase III trials is expected to turn out to be the most effective treatment of Acute Bacterial Skin and Skin Structure Infections. DelveInsight’s ‘Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Pipeline Insights’ report offers a detailed picture of the ABSSSI emerging therapies expected to enter the Acute Bacterial Skin and Skin Structure Infections market along with detailed coverage of the pipeline therapies under development in pre-clinical as well as clinical stages of development, partnerships taking place in the domain, recent happenings in space and growth prospects across the Diabetes domain. Some of the key highlights of the ABSSSI Pipeline report: Request for Sample to know more about the therapies that are set to grab maximum patient pool @ ABSSSI Emerging Therapies and Forecast Acute Bacterial Skin and Skin Structure Infection is a bacterial infection of the skin and associated tissues. The FDA defines skin and skin structure infections as an acute bacterial skin and skin structure infection or ABSSSI if the infection is accompanied by redness, edema, and/or induration of a minimum surface area of 75 cm2, accompanied by lymph node enlargement or systemic symptoms such as fever ≥38°C (100.4°F). Some of the most common bacterial pathogens that cause Acute Bacterial Skin and Skin Structure Infections are Streptococcus pyogenes and Staphylococcus aureus, including methicillin-resistant S.aureus. Less common causes include other Streptococcus species, Enterococcus faecalis, or Gram Negative bacteria. The severity of Acute Bacterial Skin and Skin Structure Infections has led to an increasing emphasis on the identification of novel strategies to treat this disease. For more information on emerging drugs, visit Acute Bacterial Skin and Skin Structure Infections Pipeline Analysis ABSSSI Pipeline Drugs Request for Sample to know more @ Acute Bacterial Skin and Skin Structure Infections Pipeline Analysis, Key Companies and Futuristic Trends Acute Bacterial Skin and Skin Structure Infections Drugs and Therapeutic Assessment The ABSSSI Pipeline report presents comprehensive insights into active ABSSSI pipeline assets segmented by Stage, ABSSSI Product Type, Route of Administration, Molecule Type, Target, and Indications of various drugs. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets By Stage and Route of AdministrationBy Stage and Product Type Reach out for Rich and Deep Market Assessment and Consulting Solutions Scope of the Report Coverage: GlobalKey Players: Basilea Pharmaceutica, TenNor Therapeutics, Innovation Pharmaceuticals, Debiopharm Group, MicuRx Pharmaceuticals, Taxis Pharmaceuticals, Botanix pharmaceuticals, Motif Bio, KBP Biosciences, Atox Bio and others. Key ABSSSI Pipeline Therapies: Ceftobiprole medocaril, TNP-2092, Brilacidin, Afabicin, Contezolid acefosamil, TXA709, Cannabidiol, KBP-7072, Nemonoxacin, AB-103 and others. Reach out @ Acute Bacterial Skin and Skin Structure Infections Pipeline: Novel therapies and emerging technologies Table of Contents Visit to know more of what’s covered @ ABSSSI Emerging Therapies Related ReportsAcute Bacterial Skin And Skin Structure Infections MarketDelveInsight's "Acute Bacterial Skin and Skin Structure Infections - Market Insights, Epidemiology, and Market Forecast-2030" report. Acne Vulgaris MarketDelveInsight's "Acne Vulgaris Market Insights, Epidemiology, and Market Forecast-2030" report. Moderate To Severe Atopic Dermatitis MarketDelveInsight's "Moderate to Severe Atopic Dermatitis (AD) - Market Insights, Epidemiology, and Market Forecast-2030" report. Acral Lentiginous Melanoma MarketDelveInsight's "Acral lentiginous melanoma - Market Insights, Epidemiology, and Market Forecast-2030" report. Androgenetic Alopecia MarketDelveInsight's "Androgenetic Alopecia Market Insights, Epidemiology, and Market Forecast-2030" report. Related Posts ABSSSI Market and Key Treatments Atopic Dermatitis MarketRosacea Pipeline and Therapies Marijuana Clinical TrialsOpiate Withdrawal Cocktail About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing end-to-end comprehensive solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. For more insights, visit Pharma, Healthcare, and Biotech News

100 Deals associated with Contezolid Acefosamil

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Complicated skin and soft tissue infection	Phase 3	CN	Shanghai MicuRx Pharmaceutical Co., Ltd.	26 May 2023
Diabetic foot infection	Phase 3	US	MicuRx Pharmaceuticals, Inc.	03 May 2022
Diabetic foot infection	Phase 3	CN	MicuRx Pharmaceuticals, Inc.	03 May 2022
Diabetic foot infection	Phase 3	AR	MicuRx Pharmaceuticals, Inc.	03 May 2022
Diabetic foot infection	Phase 3	BR	MicuRx Pharmaceuticals, Inc.	03 May 2022
Diabetic foot infection	Phase 3	BG	MicuRx Pharmaceuticals, Inc.	03 May 2022
Diabetic foot infection	Phase 3	CL	MicuRx Pharmaceuticals, Inc.	03 May 2022
Diabetic foot infection	Phase 3	HR	MicuRx Pharmaceuticals, Inc.	03 May 2022
Diabetic foot infection	Phase 3	EE	MicuRx Pharmaceuticals, Inc.	03 May 2022
Diabetic foot infection	Phase 3	GE	MicuRx Pharmaceuticals, Inc.	03 May 2022

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20231611 (NEWS) Manual	Phase 3	Complicated skin and soft tissue infection	-	MRX-4转口服康替唑胺片	yfiwmodtun(ucezxjkzkl) = MRX-4/康替唑胺片治疗复杂性皮肤和软组织感染的临床疗效非劣效于利奈唑胺组，本研究达到主要疗效终点。 wyheipvsks (hwjxnxihks ) Met View more	Non-inferior	29 Nov 2024
NCT03747497 (CTgov)	Phase 2	Skin Diseases, Bacterial \| Gram-Positive Bacterial Infections \| Skin and skin structure infections	196	contezolid acefosamil (Contezolid Acefosamil)	hrhmopazgn(bcumcvpxgq): Median Difference (Net) = -0.6 (95% CI, -14.0 to 2.8)	-	30 Apr 2021
NCT03747497 (CTgov)	Phase 2		196	linezolid 600 mg (Linezolid)		-	30 Apr 2021

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