Phase 2B Trial to Use Smartphones to Acquire Data with Partner Science37
Leading skin microbiome company AOBiome announced today the launch of its Phase 2B trial using its first-in-class live bacteria to treat acne. Phase 2B marks the advancement from the company’s successful Phase 1B/2A dose-ranging safety study, which resulted in no serious adverse events and no difference in adverse events between treatment and vehicle groups. The Phase 2B trial is being jointly conducted with Science 37, a clinical research organization applying breakthrough telemedicine-based approach to bring clinical trials directly to patients’ homes. With approximately 372 adult patients enrolled for the treatment of mild-to-moderate acne vulgaris in adults with AOB, the trial will also employ smartphones for collecting real-time patient data – an industry first. The study is expected to be completed by Q3 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 Science37, which will feature one-to-one randomized, double-blind, and placebo controlled doses, over the course of 12 weeks. AOB’s unique safety profile allows us to reach more patients and to rapidly test for clinical efficacy across multiple disease states, with acne being the first,” says Chief Medical Officer Dr. Larry Weiss.
Acne is an inflammatory skin disease that currently affects an estimated 80 million Americans, and is the most common skin condition in the US. By treating acne with live, ammonia-oxidizing bacteria, AOBiome is setting the stage for the topical treatments and clinical trials of tomorrow. The company is advancing the conventional Germ Theory of Disease by reintroducing ancestral keystone commensal bacteria to our skin’s natural microbiome. In the last ten years, the medical community has seen similar shifts, such as the recognition of the gut microbiome and its key role in overall health.
“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,” says Todd Krueger, President of AOBiome.
Until now, the study of acne treatments largely depends on a dermatologist’s ability to count the number of breakouts on a patient’s face in person. Pervasive skin diseases like acne are great candidates for Science 37 teledermatology-based assessment. Teledermatology has been one of the most popular applications of e-health and telemedicine to capture information and visual data from dermatology patients, while tracking progress.
“With Science 37’s technology, decentralized operating model, and clinical trials management, the process to participate in this AOBiome trial will be much easier for patients, and unlocks their access to our expert Science 37 researchers around the country,” said Dr. Noah Craft, MD, PhD cofounder and CEO of Science 37. “We are thrilled to leverage emerging technologies and strategic partnerships with companies like AOBiome, which is committed to improve the lives of our patients and to accelerate finding new cures for the people that need them most.”
With the introduction of smartphones during the Phase 2B trial, patients can safely take part no matter their location, and using medications and iPhones shipped personally to them. The study is currently enrolling acne patients from 9 U.S. states.
AOBiome is a Boston and San Francisco based biotech company focused on transforming human health through products that restore ammonia oxidizing bacteria (AOBs) which current hygiene practices have stripped from the modern microbiome. Founded in 2013, the company is developing a novel class of therapeutics to improve skin health as well as other systemic conditions. AOBs convert ammonia and urea in sweat to nitrite, an anti-microbial compound, and nitric oxide, a well-documented signaling molecule in the inflammatory process. AOBiome also owns the Mother Dirtbranded line of consumer biome-friendly products targeted at restoring and maintaining the delicate balance of the skin biome. Learn more at AOBiome.
About Science 37
Science 37 is a Los Angeles based technology-enabled clinical research company. They created a new clinical trial operating model – the metasite™ – that unlocks access so researchers can find the right patients, and patients can find the right trials. Their Network Oriented Research Assistant, NORA®, is the cloud-based patient-centric mobile research platform that connects everyone – safely and securely. Science 37 offers end-to-end clinical trial services without geographic limitations, making clinical research faster to accelerate biomedical discovery in all therapeutic areas. Ultimately, Science 37 enables better, faster people-powered science and brings clinical trials to scale. Learn more at Science37.