Achaogen Eliminating 80 Jobs, 28% of Staff, in Restructuring | Bio Tech

Achaogen is eliminating about 80 employees— approximately 28% of its workforce—in a restructuring designed to cut costs and refocus the antibacterial drug developer on the commercial launch of its complicated urinary tract infections (cUTI) treatment Zemdri™ (plazomicin) and two development programs.

Achaogen said that launch will be among its priorities following the restructuring, as well as its Marketing Authorization Application (MAA) filing for Zemdri in the E.U.; the development of C-Scape, a Phase I oral combination of ceftibuten, an approved third generation cephalosporin, and clavulanate, an approved beta-lactamase inhibitor; and the development of new aminoglycoside antibiotics, now in the preclinical stage.

Earlier this year the company announced positive topline results from the Phase I trial (NCT03163550) assessing the pharmacology, dosing and safety of C-Scape (also known as ACHN-383 and ACHN-789).

Zemdri is a once-daily aminoglycoside indicated for adults with cUTI, including pyelonephritis, caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae. Zemdri won FDA approval on June 25. Zemdri was developed in part with funding from the Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201000046C.

BARDA is also helping fund development of C-Scape. As of March 31, 2018, $9.6 million remained under the BARDA C-Scape contract, and up to an additional $6 million may be available under BARDA contract option, Achaogen disclosed May 4 in reporting Q1 results.

The development of the new aminoglycoside program is being supported by an up-to-$12 million award from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a partnership between BARDA and the U.K.’s Wellcome Trust charity established in 2016 to support the global development of novel antibacterial drugs that address multidrug-resistant (MDR) infections.

“Despite being on course for a successful launch of ZEMDRI in the United States and a MAA filing in the EU in the second half of this year, the environment for novel antibacterials requires us to improve our cost structure and narrow our focus to position the company for long-term success,” Achaogen CEO Blake Wise said yesterday in a statement.