Achaogen's stocks fly high on antibiotic clinical success
- Plazomicin, the lead project from Achaogen, has driven the South San Francisco biopharma's stock up by almost 150% on the news that it has succeeded in meeting its clinical endpoints in the Phase 3 EPIC study. The drug has achieved both non-inferiority and superiority against meropenem in complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).
- Additionally, in the Phase 3 CARE trial, plazomicin cut death and serious disease-related complications in serious infections caused by carbapenem-resistant Enterobacteriaceae (CRE), compared with colistin, one of the last-chance antibiotics for this infection.
- Achaogen plans a U.S. submission in the second half of 2017, and a European submission in 2018.
Antibiotic resistance is a growing cloud on the healthcare horizon, potentially affecting procedures across modern medicine, from cancer treatment to planned and emergency surgery and beyond. Achaogen's dramatic stock leap of almost 150% reflects the importance that the whole of the healthcare industry places on companies that could potentially help to fight this battle.
Complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), can persist or recur. These may be related to another underlying condition, such as diabetes, and this increases the risk of treatment failure. The Centers for Disease Control and Prevention (CDC) describes carbapenem-resistant Enterobacteriaceae (CRE) infections, as "an important emerging threat to public health." The death rate linked with CRE infections can be as high as 50%, and Reuters reported around 65,000 to 75,000 cases in the U.S. last year.
"These data are… 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.
Katherine Xu at William Blair estimates peak sales of plazomicin of up to $340 million in 2031, but as with all new antibiotics, this will of course depend on whether it is used routinely or reserved for critical use.
- Achaogen Statement
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