MicuRx Pharmaceuticals, Inc. announced on 9/21/18 the receipt of the qualified infectious disease product (QIDP) classification and grant of fast track status by the U.S. Food and Drug Administration (FDA) for contezolid (MRX-I) and its prodrug contezolid acefosamil (MRX-4) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

QIDP designation is granted under the U.S. Generating Antibiotic Incentive Now (GAIN) Act, which is part of the FDA Safety and Innovation Act of 2012 (FDASIA). The Act provides incentives for the development of antimicrobials active against priority bacterial pathogens, and includes Fast Track designation for review and five years of market exclusivity added to any non-patent exclusivity.

“MicuRx is proud to have received QIDP and Fast Track designation for our oxazolidinone agents, contezolid and the prodrug contezolid acefosamil,” commented Mike Gordeev, Ph.D., MicuRx’s Chief Scientific Officer. “We believe that this FDA designation affirms the need for new drugs effective against the priority pathogens methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE).”

Contezolid and contezolid acefosamil are next-generation oxazolidinone agents with notably reduced hematologic toxicity compared to earlier antibiotics of this class, such as linezolid, while maintaining the excellent therapeutic efficacy of the class. Contezolid and contezolid acefosamil are active against multidrug-resistant, Gram-positive organisms, including MRSA and VRE, which are categorized as a high threat by the World Health Organization.

“Despite recent antibiotic launches, unmet needs still exist for an oral anti-MRSA agent with a safety profile appropriate for extended treatment, especially in the outpatient setting,” stated Barry Hafkin, M.D., MicuRx’s Chief Medical Officer. “We believe that our contezolid portfolio offers a unique profile with excellent clinical safety and efficacy results to date, with the flexibility of intravenous and oral formulations. Transitioning patients with serious infections from the hospital to oral outpatient treatment as soon as possible is a more convenient and more cost effective treatment compared to continued hospitalization or outpatient IV treatment.“

The company began Ph III trials of the oral form of contezolid in China in October of 2016. An IND for oral contezolid acefosamil was filed in China in June of 2018.