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

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