MicuRx Announces CARB-X US$7.78 Million Funding for Development of MRX-8

--and FDA Clearance for Phase 1 Trial of the Novel Antibiotic--

News provided by

Aug 13, 2020, 08:15 ET

FOSTER CITY, Calif. and SHANGHAI, Aug. 13, 2020 /PRNewswire/ -- MicuRx Pharmaceuticals Inc. today announced that the global partnership Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has committed up to US$7.78 million of nondilutive financing for a Phase 1 clinical trial and related R&D activities of its new antimicrobial agent MRX-8. Previously, CARB-X has funded investigational new drug (IND) enabling studies for MRX-8 in the US.

MicuRx also announced that the FDA has completed review of the IND application for MRX-8 and gave clearance for the first-in-human clinical trial to proceed. The CARB-X funding will be used to support the Phase 1 trial, as well as activities essential for future Phase 2 clinical trials.

MRX-8 is a novel polymyxin active against infections caused by multidrug-resistant (MDR) Gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. Its potent antimicrobial coverage is characteristic of this prominent antibiotic class represented by the current drugs colistin and polymyxin B (PMB). The new agent is beneficially differentiated by its minimized nephrological and neurological toxicities. Nephrotoxicity manifests as acute kidney injury, occurring with an incidence of up to 60% in patients treated with colistin and PMB, relegating the current polymyxins to a last-resort therapeutic option.

An improved renal safety of MRX-8 was established in multiple preclinical tests, including toxicity studies in nonhuman primates. Furthermore, MRX-8 has exhibited superior efficacy to PMB in certain nonclinical models of Gram-negative infections, such as urinary tract and lung infection animal models.

"We are very grateful to collaborate with CARB-X in addressing the global need for safer and more effective antibiotics, and appreciate the generous financial and technical support from this non-profit partnership comprised of prominent funding institutions and leaders in the R&D of antibacterials," stated Zhengyu Yuan, PhD, President and CEO of MicuRx.

MRX-8 was discovered by MicuRx scientists and the company owns worldwide IP rights to its composition and use. This innovative agent has advanced from the original concept through a successful US IND application, and towards the first-in-human Phase 1 study. This progress underscores the MicuRx commitment to develop innovative antibiotics against resistant bacterial pathogens. The new drug candidate MRX-8 compliments NDA-track agent contezolid and Phase 2 agent contezolid acefosamil, to establish a complete line of MicuRx products for therapies of serious Gram-negative and Gram-positive bacterial infections.

About MicuRx Pharmaceuticals, Inc.

MicuRx is a privately held biopharmaceutical company focusing on discovering and developing antibiotics with improved safety profiles to treat resistant bacterial infections. The lead compound, contezolid, a next-generation oxazolidinone targeting methicillin-resistant S. aureus, was structure-designed to reduce hematological adverse effects of this antibiotic class. MicuRx completed two Phase 2 studies in the US and China for contezolid. After completing a successful Phase 3 study in China for the treatment of complicated skin and soft tissue infections, the company filed an NDA with the NMPA of China for contezolid at the end of 2019. The company has research and development facilities outside San Francisco, CA, in the United States, and in Shanghai, China. Visit www.micurx.com for more information.

About CARB-X

CARB-X is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, Germany's Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care's Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID). CARB-X is investing up to $500 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics. CARB-X supports the world's largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. carb-x.org/. Follow us on Twitter @CARB_X.

This press release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from Wellcome Trust. The contents are solely the responsibility of the authors and do not necessarily represent the official views of CARB-X, the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.

Contacts
Zhengyu Yuan, PhD
President and CEO
MicuRx Pharmaceuticals, Inc.
[email protected]

For CARB-X:
Media contact: Jennifer Robinson, [email protected]

SOURCE MicuRx Pharmaceuticals