AOBiome is running an iPhone-enabled Phase IIb trial of its bacterial treatment for acne. The clinical trial, which AOBiome is working on with Novartis ($NVS)-backed virtual trial CRO Science 37, is shipping iPhones to 372 participants to enable them to document and share their condition with researchers.
On one level, the trial looks like a fairly typical Phase IIb study. Having generated safety and dosing data in a Phase Ib/IIa trial, AOBiome is now running a 12-week, randomized, placebo-controlled trial to assess whether the skin condition of people with mild to moderate acne vulgaris improves after applying B244, a topical ammonia oxidising bacteria-based candidate.
That is where the similarity with other Phase IIb trials ends. The ClinicalTrials.gov entry for the trial lists just one site, the headquarters of Science 37 in California.
The stripped-down approach to site activation is made possible by the use of smartphones from Apple ($AAPL), which the study team will ship along with the medication or placebo to everyone who enrolls in the study. The iPhones are loaded with technology from Science 37, which has developed a mobile app through which participants can chat to the study team, complete surveys and share photographs.
AOBiome is leveraging these features to capture data against its joint primary endpoints. Subjects will report adverse events and share images for assessment by researchers, enabling AOBiome to move away from traditional approaches that rely on dermatologists at each trial site counting breakouts on subjects’ faces. In doing so, AOBiome has also severed the link between participation and proximity to a study site.
“Through this partnership, AOBiome is able to engage with a significantly wider and more diverse population faster, and more cost effectively, than traditional methods,” AOBiome President Todd Krueger said in a statement.
That sunny outlook could be darkened if AOBiome runs into the issues that have blighted other virtual trials. Pfizer’s ($PFE) enrollment woes are the highest-profile problem, while some attempts to use Apple’s ResearchKit to run observational studies have struggled to retain participants.
As a venture-backed company that is looking to the Phase IIb trial to generate safety and efficacy data on its lead candidate, AOBiome has a lot more resting on the study than Pfizer did when it ran its virtual trial experiment. That it has been willing to take the leap is testament to the progress made by Science 37 in moving the virtual trial concept into the mainstream.
Science 37 was thrust into the headlines 11 months ago when dRx Capital, the $100 million VC shop created by Novartis and Qualcomm ($QCOM), co-led a $6.5 million Series A in the tech-enabled CRO. That round also attracted the support of Lux Capital, giving Science 37 and its approach to trials the nebulous benefits that come from landing well-regarded financiers.