MicuRx raises $55M to wrap up Phase III antibiotic trials, file NDA in China

Sino-American biotech MicuRx Pharmaceuticals has raised $55 million to fund a pair of late-phase trials of its antibiotic. The Series C round will enable MicuRx to wrap up Phase III trials of the antibiotic in the U.S. and China, before going on to file for approval in the latter of the two countries.

GP Healthcare Capital led the round, which also attracted the support of three new investors: GP TMT Capital, 3E Bioventures Capital and Delian Capital. The financiers have come on board to give MicuRx the means to execute some of the final steps in its 9-year drive to bring the antibiotic MRX-I to market, first in China and then potentially in the U.S. and further afield.

“The fast growing pharmaceuticals market in China, presents an excellent opportunity for MRX-I,” MicuRx CEO Zhengyu Yuan said in a statement. "We are very pleased to have the solid support of such a strong syndicate which will fund MicuRx through our first new drug application (NDA) filing in China.”

Featured Webinar

From Concept to Market: Overcoming the Challenges of Manufacturing and Clinical Trials

In this webinar we will reveal the inner workings of the manufacturing and pharmacy department of a CRO/CDMO, so you understand the different regulatory and operational considerations faced by a clinical research pharmacy.

Learn how CRO/CDMOs successfully address operational and regulatory challenges for pharmaceutical and biotechnology clients; and how this can make the difference between study success or failure.

The filing of the NDA in China is one of three items on MicuRx’s to-do list now that it has raised the cash. Before it can submit the NDA, MicuRx must successfully execute one of the other items, namely the delivery of data from a Chinese Phase III trial of an oral formulation of MRX-1 in complicated skin and skin structure infections.

In parallel to the China-focused R&D push, MicuRx is working on one of the pivotal trials needed to win FDA approval for MRX-1. MicuRx expects to complete the study, which is assessing oral and intravenous formulations of the drug in acute bacterial skin and skin structure infections, before the $55 million runs out.

The split focus between the U.S. and China is a reflection of the composition of MicuRx, which was set up in 2007 by Yuan and Mike Gordeev to tap into the then-nascent R&D capabilities of the latter country. Yuan and Gordeev, who still works as CSO of MicuRx, set up the business after working together at Vicuron Pharmaceuticals, a developer of antifungal and antibacterial drugs that was bought by Pfizer ($PFE) for $1.9 billion in 2005.

MicuRx started life by putting together a $10 million Series A before going on to strike--and then promptly lose--a pact with Pfizer. A $25 million Series B followed in 2013, giving MicuRx the means to advance an oxazolidinone antibacterial against multidrug-resistant Gram-positive bacteria through Phase II. Data from the trial dropped late last year, pushing MicuRx on to the next stage of its evolution and necessitating the raising of additional capital.


Suggested Articles

Ironwood had once hyped this drug as a $2 billion-a-year asset, but IW-3718 has failed to live up to its high expectations.

The company describes the continuous glucose monitor as the world’s smallest and thinnest diabetes sensor, with a disc about the size of two pennies.

Junshi’s PD-1 blocker is already approved in China for metastatic melanoma, but the Shanghai-based biotech may soon add throat cancer to its label.