Biotech Values

[apljack]

AKAO: Anyone on this board following Achaogen, a clinical antibiotic drug development company? I've been looking through their site and data on their lead candidate, plazomicin and the data is respectable (at least from what I can see.) The co. looks well enough funded for their phase 3 trial, to begin in Q4, 2015. However, the statement below is something of a concern regarding the sample size. Please feel free to chime in if you have an opinion regarding the co. the sample size statement, or other thoughts/opinions regarding this co.

The Phase 3 cUTI trial will be a randomized, double blind, active controlled study in patients with cUTI and acute pyelonephritis. This will be a non-inferiority trial comparing plazomicin to meropenem with a 15% non-inferiority (NI) margin. As such, the trial will have a sample size of approximately 530 patients, which is significantly smaller than prior industry-sponsored Phase 3 cUTI trials. The Company believes that this reflects the FDA's recognition of the unmet need for new antibiotics that treat MDR bacterial infections with high morbidity and mortality. The Company estimates the Phase 3 cUTI trial will necessitate additional Achaogen funding of $45-50 million from 2015 through 2017, which the Company anticipates will be primarily accessed via non-dilutive sources such as government contracts, grants, and debt.

http://www.achaogen.com/