MicuRx Pharmaceuticals Reports Positive Top-Line Results from a US Phase 2 ABSSSI Clinical Trial of Novel Antibiotic Contezolid Acefosamil
Time:2019-09-09 / View:485 times
FOSTER CITY, California, and SHANGHAI, China -September 9, 2019. MicuRx Pharmaceuticals, Inc., today announced positive top-line results for study MRX4-201, a US Phase 2 randomized, double-blind clinical trial comparing contezolid acefosamil (MRX-4) with linezolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Contezolid acefosamil met all primary and secondary efficacy endpoints with a potentially improved hematologic safety profile.
“We sincerely appreciate the participation of the patients and the investigators and their study staff in this Phase 2 clinical trial,” said Dr. Zhengyu Yuan, President and CEO of MicuRx. “We are very pleased with the excellent results of this study and plan to advance contezolid acefosamil into Phase 3 development next year,” continued Dr. Yuan. “The IV and oral formulations of contezolid acefosamil appear to be effective in treating ABSSSI, including MRSA infections, as evaluated by endpoints consistent with FDA and EMA bacterial skin infection clinical trial guidance documents, with a dosing regimen that was safe and well-tolerated,” said Edward Fang, MD, Senior Vice President, Clinical Development. “The Phase 2 data support proceeding to pivotal Phase 3 ABSSSI and diabetic foot infection (DFI) studies, and the lower frequencies of hematologic laboratory abnormalities observed with contezolid acefosamil compared with linezolid suggest a potential improvement in safety over other oxazolidinones that may prove even more significant in patients with DFI who often require treatment beyond 14 days,” added Dr. Fang. MicuRx plans Phase 3 clinical trials in ABSSSI and DFI in order to confirm the safety and efficacy profile of contezolid acefosamil, including with longer duration therapy. About MicuRx Pharmaceuticals, Inc.
MicuRx Pharmaceuticals (http://www.micurx.com/) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of antimicrobial therapeutics for multidrug-resistant (“MDR”) “superbug” infections. Since our inception in 2007, we have leveraged our management team’s extensive experience in the discovery and development of novel antimicrobial agents, and our scientists in the US and China have built a pipeline that includes contezolid (MRX-I), contezolid acefosamil (MRX-4), MRX-8 (novel polymyxin MDR Gram-negative agent), and MRX-12 (new class MDR Gram-negative agent). Our mission is to combat pathogens on the WHO list of “superbugs”. Our lead compound, contezolid (MRX-I), a next-generation oxazolidinone targeting methicillin-resistant Staphylococcus aureus (MRSA), was structure-designed to reduce the hematologic toxicity and monoamine oxidase inhibition risk of this antibiotic class. In 2015, MicuRx completed two independent Phase 2 studies in the US and China for oral contezolid, and in 2019, completed a Phase 3 study in China for the treatment of complicated skin and soft tissue infections (cSSTI). Contezolid acefosamil (MRX-4) is a prodrug of contezolid and is planned for global development in battling MDR Gram-positive infections with both oral and IV formulations. Both contezolid and contezolid acefosamil have been granted QIDP designation and Fast Track status by the US FDA. MicuRx has R&D centers outside of San Francisco, California, and in Shanghai, China. The company has raised a total of US$107 million through leadin