Slingshot Contributor: Sam Jordan
We’re interviewing a specialist in infectious diseases with specific experience treating and/or studying Multidrug-resistant Gram-negative bacteria. This interview will evaluate the likelihood of approval and the commercial potential for Plazomicin as a treatment for carbapenem-resistant Enterobacteriaceae (CRE) following the NDA filing on October 26th.
Why Investors Should Care:
Multi-drug resistance, especially in bacteria is a serious, growing, threat to public health
Multi-drug resistant bacteria are resistant to antibiotics and are often fatal due to lack of viable treatment options
Plazomicin is designed to treat a specific kind of MDR Bacteria, carbapenem-resistant Enterobacteriaceae, that is resistant to current MDR Bacteria treatments
Phase III data showed that Plazomicin delivered significantly higher cure rates than current treatment options
While Phase III trials were successful overall, there are still some questions surrounding the data
Plazomicin’s did not outperform the control at the five-day mark, an FDA specified primary endpoint
Plazomicin is Achaogen’s lead drug candidate and its only drug candidate past Phase I trials
About the Company
Achaogen Inc (NASDAQ: AKAO) is a biotechnology company that focuses on the development of antibiotics to treat multi-drug resistant gram-negative bacteria. Plazomicin is its lead drug candidate and it's only drug close to commercialization. The company's stock jumped in multiples of price following the Phase III data release but has since drifted lower.
Why Speak to an Expert:
An expert can evaluate the results of Phase III trials
An expert can provide in-depth expertise in the field of MDR Bacteria
An expert can inform you about current treatment options for CRE and cUTIs
Who's the Expert?
A specialist in infectious diseases with specific experience treating and/or studying Multidrug-resistant Gram-negative bacteria
Questions Investors Are Asking the Expert:
What is your experience with treating Multi-Drug Resistant Bacteria, specifically carbapenem-resistant Enterobacteriaceae? Have you seen an increase in cases?
The CDC has called CRE a "nightmare bacteria", can you talk about what makes this specific kind of bacteria is so dangerous?
What are the current treatment options available for CRE and how do they compare in terms of safety and efficacy to Plazomicin?
The data submitted with the NDA came from the EPIC and CARE Phase III trials. In the much larger EPIC study, "patients who met protocol-defined criteria for improvement were allowed to step-down to oral levofloxacin to complete a total of 7 to 10 days of therapy". Could the use of levofloxacin at the end of the trials raise questions during the FDA review about the efficacy of Plazomicin?
Plazomicin did not show statistical superiority at day 5 compared to meropenem. The FDA only required non-inferiority compared to meropenem, but could these results still be an issue during the FDA review process?
If approved how quickly do you see Plazomicin being adopted by medical professionals treating CRE?
Plazomicin is also being reviewed as a potential treatment for cUTIs, how does it compare to current treatment options in terms both safety and efficacy?
Do you see Plazomicin filling a significant need in the treatment of cUTIs?
Achaogen estimates in its most recent 10-K filing that CRE infects 150,000 people a year in their target markets (US, UK, France, Spain, Germany, and Italy) and these numbers have been rising. For patients with CRE that reaches the bloodstream mortality rates reach 50%. Plazomicin is a drug that meets a vital need.
Its total cure rate has been shown to be significantly higher than current treatment options making the drug of significant interest to the FDA and EMA. The interest has gained it fast-track designation by the FDA and patent protection through 2031. However, there are aspects of the critical Phase III trials for the drug that require deeper investigation.
The future of Achaogen is very closely tied to Plazomicin, therefore understanding the potential of this drug is vital to understanding the future of this company and its share price.
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