Drug Development

Achaogen slowly soars, speeding top antibiotic to FDA/EMA after PhIII scores positive results

Achaogen CEO Kenneth Hillan

Achaogen CEO Kenneth Hillan

South San Francisco-based Achaogen says its lead antibiotic plazomicin scored positive Phase III efficacy and safety data, setting it up for marketing applications on both sides of the Atlantic. And the stock price began to rise immediately, steadily gaining speed throughout the day before closing up a whopping 148%.

Achaogen $AKAO is one of a handful of biotechs in late-stage development with new antibiotics in an era of rising drug resistance to the mainstays in the field. Its top gram-negative candidate scored on non-inferiority to meropenem for the FDA requirements and looked superior by EMA standards on complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).

Looking at a modified intent-to-treat group, plazomicin beat out meropenem in a test-for-cure on the FDA standards, but came in marginally behind the comparator on the day 5 score, clearing the non-inferiority bar. The antibiotic scored better than meropenem for EMA-specified endpoints.

Achaogen CEO Kenneth Hillan says he was thrilled by the results.

“These data are exceptional and better than I would have expected – plazomicin’s superiority in microbiologic cure for patients with cUTI at the test-of-cure visit compared to meropenem, a gold standard for treating MDR infections, is impressive. Importantly, the safety profile of the drug looks favorable,” said James A. McKinnell, assistant professor of medicine at the David Geffen School of Medicine and LA Biomed at Harbor-UCLA. “The data from the CARE trial provides compelling evidence for plazomicin as a treatment option for serious infections due to CRE. The sample size for the CARE study was small, but the data show a clear trend in favor of plazomicin in terms of efficacy and overall safety compared to colistin. CRE infections cause serious morbidity and mortality and seem to be on the rise. Based on these data, plazomicin would be a valuable addition to my short list of available treatment options for both empiric and directed treatment of patients, and as a single agent or in combination with other antibiotics.”


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RAPS Regulatory Convergence 2017