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).
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. 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.”