Friday, November 11, 2016

Achaogen, Inc. (AKAO) Attacks Super Bugs: Plazomicin Phase III Trials Are Underway

The era of the super bug is upon us, and Achaogen, Inc. (NASDAQ: AKAO) has joined the fray against them. For close to one hundred years, antibiotics have lowered the prevalence and severity of infectious diseases. Increasingly, though, it is becoming apparent that the bacterial world is fighting back. Infections of the urinary tract (UTI) and others such as acne, bronchitis and streptococcal pharyngitis (strep throat) are becoming more resistant to the antibiotics that are most commonly prescribed to treat them.

And this threat is compounded by the rise of the super bug, strains of bacteria that have already evolved defenses against a range of antibiotics. However, Achaogen is close to launching a new line of attack against these pathogens. Two phase III trials for its lead product candidate are currently in progress, and top-line results from both are expected in the first quarter of 2017.

Up until the 1930s, we were at the mercy of bacterial infections. Indeed, it was only about half a century before, in 1876, when German physician Robert Koch, in identifying the causes of anthrax, cholera and tuberculosis, showed that bacteria caused disease. In 1928, Dr. Alexander Fleming made the astounding discovery that the penicillium mold inhibited the growth of bacteria, and the penicillin extracted there from set a new paradigm for twentieth-century medical science. A PBS story ( gives some idea of its success:

“In the war, penicillin proved its mettle. Throughout history, the major killer in wars had been infection rather than battle injuries. In World War I, the death rate from bacterial pneumonia was 18 percent; in World War II, it fell, to less than 1 percent.”

Dr. Fleming was awarded the Nobel Prize in 1945, and, in his acceptance speech, he issued a prescient warning that the improper use of penicillin might eventually make it ineffective. If the drug could ‘be bought by anyone in the shops, then there is the danger that the ignorant man may easily under dose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.’ Unfortunately, this prophesy has come true. Not only for penicillin, but for a wide range of other antibiotics, effectiveness today is markedly down from previous decades.

These dangers are exacerbated by a range of super bugs that are multi-drug resistant (MDR) and include carbapenem-resistant Enterobacteriaceae (CRE). Generally, healthy people in their normal environments do not contract CRE infections. Such maladies arise in hospitals, nursing homes, and other health care settings. It is for such malaises that Plazomicin is being developed. The drug will be used to treat serious bacterial infections due to MDR Enterobacteriaceae, including CRE.

It is currently being evaluated in two phase III clinical trials. For the first, designated EPIC (Evaluating Plazomicin in cUTI), Achaogen completed enrollment ahead of schedule in September with 609 patients. Top-line results are expected in the first quarter of 2017. The EPIC study is intended to serve as a single pivotal trial supporting a New Drug Application (NDA) for Plazomicin in the United States in the second half of 2017.

The second CARE (Combating Antibiotic Resistant Enterobacteriaceae) Phase III trial is for patients with serious bacterial infections due to CRE. Due to rapid completion of enrollment of the EPIC trial, Achaogen closed enrollment in the CARE trial with 69 patients and expects to announce top-line data from this trial early in the first quarter of 2017 as well. Results from CARE will be submitted with the NDA.

The FDA has granted Qualified Infectious Disease Product (QIDP) designation to Plazomicin, and development and regulatory review of its use to treat serious and life-threatening CRE infections has been given Fast Track status. The plazomicin program is partially funded by up to $103.8 million from the Biomedical Advanced Research and Development Authority (BARDA).

A report ( from Aegis Capital Corp. has set a target PPS of $10.00 for Achaogen. The company’s stock, under the symbol AKAO, is currently trading on the NASDAQ at under $5.00.

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