Achaogen Inc (NASDAQ:AKAO) lead antibiotic candidate, plazomicin, turned out successful in two key late-stage studies, paving the way for the company to seek regulatory clearance to bring the drug to market.
In a Phase 3 study dubbed CARE, plazomicin was tested against colistin therapy in patients suffering from serious infections as a result of carbapenem-resistant enterobacteriaceae (CRE). The outcome was lower mortality rates, and in some cases lower serious complications, in the group of patients who received plazomicin compared to those who received colistin therapy treatment. Colistin therapy is one of the antibiotics used in tackling CRE.
Though CRE is rare, the CDC describes it as a nightmare bacteria because it spreads easily, can kill up to 50% of its victims and has developed resistance against many existing antibiotics.
Achaogen said about 75,000 CRE cases were reported in the U.S. in 2015.
Success against cUTI
The other Phase 3 study dubbed EPIC tested plazomicin in patients suffering from acute pyelonephritis and complicated urinary tract infections (cUTI). The drug was successful in treating the conditions.
Seeking regulatory approval
Achaogen will include data from the CARE and EPIC studies in its application for marketing approval of plazomicin. The company intends to apply for FDA approval in the back half of 2017 and for European approval in 2018.
Some analysts have estimated that plazomicin could fetch peak sales of $270 million in cUTI market and $70 million in CRE market if successful.
Fundraising for plazomicin program
Following the success of plazomicin in the two crucial late-stage studies, Achaogen has announced AN equity fundraiser. The company has kicked off a process that would see it sell at least 5.75 million new shares of its common stock.
Achaogen will update on the offering price later, but it says the proceeds from the shares sale will go to developing of plazomicin and preparation for its commercialization.
Shares of Achaogen rose more than 148% to close at $13.03 in the last session after news that plazomicin succeeded in two key Phase 3 studies entered the market.