Achaogen (AKAO) Says Phase 3 EPIC Trial Enrollment Complete

September 1, 2016 8:05 AM EDT
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Achaogen, Inc. (Nasdaq: AKAO) announced that it has completed patient enrollment ahead of schedule in its Phase 3 EPIC registration clinical trial of plazomicin. Additionally, the Company has closed enrollment in the Phase 3 CARE trial of plazomicin and expects to report top-line results from both the EPIC and CARE clinical trials early in the first quarter of 2017. Achaogen is developing plazomicin to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).

"We are extremely grateful to the patients, investigators and clinical trial sites that participated in the EPIC trial. Their extraordinary teamwork enabled us to quickly enroll the EPIC trial in less than eight months, significantly faster than our original projections. We look forward to announcing top-line data early in the first quarter next year,” said Kenneth Hillan, M.B., Ch.B., Achaogen's Chief Executive Officer. “With the rapid completion of the EPIC trial, we closed enrollment in the CARE trial several months earlier than anticipated and we are one step closer to our goal of submitting the plazomicin NDA in the second half of 2017 and, if approved, making plazomicin available as an important option for treating patients with CRE infections.”

About the Phase 3 EPIC Clinical Trial

EPIC (Evaluating plazomicin in cUTI) is a multi-national, randomized, controlled, double-blind clinical trial in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), which is expected to create a substantial opportunity for plazomicin to address the unmet medical need arising from multi-drug resistant (MDR) infections. EPIC is evaluating the efficacy and safety of plazomicin compared to meropenem and 609 patients were randomized to receive either plazomicin or meropenem intravenously. The primary objective of the EPIC trial is to demonstrate the non-inferiority, with a 15% non-inferiority margin as agreed by FDA, of plazomicin compared to meropenem based on the difference in composite microbiological eradication and clinical cure rate in the microbiological modified intent-to-treat (mMITT) population at both the Day 5 and test-of-cure visits. The Company expects the EPIC trial to serve as a single registration trial and support a New Drug Application (NDA) submission in the second half of 2017.

About the Phase 3 CARE Clinical Trial

CARE (Combating Antibiotic Resistant Enterobacteriaceae) is a resistant pathogen-specific trial that describes the efficacy and safety of plazomicin in patients with infections due to CRE. Due to the rapid completion of enrollment of the EPIC trial, the Company closed enrollment in the CARE trial several months earlier than anticipated with a total of 69 patients enrolled. CARE contains a randomized, open-label cohort (Cohort 1; 39 patients) that compares the efficacy and safety of plazomicin with colistin in the treatment of patients with bloodstream infections (BSI) or hospital-acquired pneumonia (HABP, VABP) due to CRE. An additional single-arm cohort (Cohort 2; 30 patients) enrolled patients with BSI, HABP, VABP, cUTI or AP due to CRE, and who were not eligible for enrollment in Cohort 1, to be treated with plazomicin-based therapy. The Company plans to submit the Phase 3 CARE trial results as supportive data with the plazomicin NDA, which is based on the Phase 3 EPIC trial, and to submit the results to peer-reviewed journals and for presentation at medical meetings. The CARE trial is primarily a descriptive study (no formal hypothesis testing will be performed); the Company believes the trial will provide important and meaningful data regarding the efficacy, safety, microbiology, and dosing, to better inform physician use of plazomicin in the potential treatment of patients with CRE infections.



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