Achaogen Rises on Late-Stage Win

Health and Healthcare

Published: December 12, 2016 10:35 am

Last Updated: January 12, 2020 4:51 pm

Achaogen Inc. (NASDAQ: AKAO) shares saw a huge gain on Monday after the company reported positive results from its late-stage trial. The company announced that its lead product candidate, plazomicin, met the objective of non-inferiority compared to meropenem for the U.S. Food and Drug Administration (FDA) and achieved superiority for the European Medicines Agency (EMA) primary efficacy endpoints in the Phase 3 EPIC registration trial in patients with complicated urinary tract infections and acute pyelonephritis.

Additionally, in the Phase 3 CARE trial in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE), a lower rate of mortality or serious disease-related complications was observed for plazomicin compared with colistin therapy, one of the few remaining antibiotics for treatment of infections due to CRE.

In the EPIC trial, plazomicin successfully met the objective of non-inferiority compared to meropenem for the FDA-specified primary efficacy endpoints and achieved superiority for the EMA-specified primary efficacy endpoints.

The company plans to submit a New Drug Application (NDA), which will include EPIC and CARE data, to the FDA in the second half of 2017. Achaogen also plans to submit a Marketing Authorization Application (MAA) to the EMA in 2018.

Kenneth Hillan, M.B. Ch.B., Achaogen’s CEO, commented:

We are thrilled with the outcome of both the EPIC and CARE clinical trials and the potential opportunity for plazomicin to address many of the multi-drug resistant bacterial infections occurring every day. We are grateful to the patients and investigators who were involved in both of these studies, and we look forward to seeking plazomicin’s approval from FDA and EMA. We believe that, if approved, plazomicin will provide an important new option in treating MDR infections, including those caused by CRE.

Shares of Achaogen were last seen up over 66% at $8.72, with a consensus analyst price target of $10.25 and a 52-week trading range of $2.59 to $8.70.

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