The company says it has launched Phase 2B of its trails for the treatment, following the success of initial clinical trials, knowns as the 1B/2A phase, that resulted in no adverse reactions or safety concerns.
Phase 2B is being jointly conducted with Science 37, which is a clinical research organization that has expertise relating to end-to-end clinical trials that can be carried out in individuals’ homes, thanks to telemedicine technology.
Trials include 372 using real-time telemedicine technology
The trials have enrolled 372 adult patients for the treatment of mild to moderate acne vulgaris, using smartphones to collect real-time patient data – and it is this application for the testing method that is said to be an industry first.
The trials are expected to take the best part of a year, with the publishing date of the trial results expected to be some time in the third quarter of 2017.
"With the remarkable outcome of the Phase 1B/2A study, we are excited to see the results of this upcoming Phase 2B trial with Science 37, which will feature one-to-one randomized, double-blind, and placebo controlled doses, over the course of 12 weeks,” says Chief Medical Officer Dr. Larry Weiss.
The Germ Theory of Disease
AOBiome is working around the controversial Germ Theory of Disease, which is causing a major resurgence in the belief that ‘good’ bacteria’ can do a lot to help fight many ailments and diseases.
The company is advancing this theory by introducing ancestral keystone commensal bacteria that aim to heighten the skin’s natural biome, in turn providing the right bacterial conditions to help fight acne flare ups.
Furthermore, the trial methods is also expected to bring a new and far more accurate dimension to the results, as it allows dermatologists to assess the patient outcome using a real-time method that is not limited by conventional and less flexible methods.
"We are excited to align Science 37's next generation, technologically-enabled capabilities with AOBiome's cutting edge approach to skin health. Through this partnership, AOBiome is able to engage with a significantly wider and more diverse population faster, and more cost effectively, than traditional methods," said Todd Krueger, President of AOBiome.