Contezolid was associated with fewer drug-related hematologic laboratory adverse events
A phase 3 clinical trial in China has found MicuRx Pharmaceuticals’ lead antibacterial drug candidate contezolid (MRX-I) to be effective in treating complicated skin and soft tissue infections (cSSTI).
Contezolid is designed to treat drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). It offers physicians and patients a safer tolerated therapeutic option than existing oxazolidinone agents.
The phase 3 study was conducted at 50 sites in China
In the double-blind phase 3 study, which was carried out at 50 sites in China, contezolid met the primary endpoint of noninferiority compared to linezolid for the clinical cure rate at the test-of-cure visit and was associated with lesser drug-related hematologic laboratory adverse events.
A total of 719 patients with cSSTI were randomised to receive oral contezolid 800 mg or oral linezolid 600 mg twice daily for a period of 7 to 14 days.
MicuRx said 589 patients were clinically evaluable at the TOC visit. For the CE patients, the clinical cure rates at the TOC visit were comparable for contezolid (93.0%) and linezolid (93.4%).
The overall rates of treatment-emergent adverse events (TEAEs) were comparable between contezolid and linezolid, as were the TEAEs considered by investigators to be related to study drug and most were mild or moderate in severity.
Study drug-related TEAEs reported for hematologic tests below normal were lesser for contezolid than linezolid.
Of the 405 patients that received more than 10 days of therapy, 25.4% linezolid patients experienced more than a 30% reduction in platelets counts at the end of therapy visit relative to baseline visit, while only 2.5% contezolid patients had a similar decrease.
MicuRx Pharmaceuticals president and CEO Zhengyu Yuan said: “We are very pleased with the favorable results of this Phase 3 clinical trial which established that contezolid is an effective and safer antibacterial drug.
“We plan to file a New Drug Application with the National Medical Products Administration (NMPA) of China in the 4th quarter of 2019 for this exciting new drug.”