Science 37, a trailblazing company focused on “site-less” clinical trials, announced the completion of a phase IIb study for AOBiome, a clinical-stage life sciences company, in which it screened over 8,000 people with mild-to-moderate acne and enrolled 372 participants to take part in this research study all from the comfort of their own homes. This is the first time that a phase IIb interventional randomized placebo controlled trial of this kind has been successfully run one hundred percent virtually.
“Over the last three years we have had great success using our Metasite approach to complete portions of larger trials; this is the first time we have run an entire trial virtually from start to finish,” said Noah Craft, M.D., Ph.D., the principal investigator and co-founder and CEO of Science 37. “With this technology, we were able to accelerate enrollment, capture on-the-ground results as they occurred, and ensure a greater diversity of participants in this truly patient-centered study.”
Using the NORA platform, trial participants were able to connect with Science 37 dermatology expert investigators 24/7 using a loaned iPhone and data plan, which is key to Science 37’s decentralized approach. NORA allows for video-based telemedicine visits between study staff and patients, as well as customized self-photography modules built into the platform.
Until recently, clinical trials were organized around physical sites where doctors or research centers required patients to come to them. Only when the appropriate type of patient walked through the door could a doctor properly screen potential participants for trials, which could take years. In contrast, for the AOBiome study Science 37 was able to screen over 8,000 people online and enroll 372 patients in less than seven months, which represents an approximate 50% savings on enrollment time.
The trial featured one-to-one randomized, double-blind, and placebo-controlled doses, administered over the course of 12 weeks, with four additional weeks of follow-up. Participants self-administered AOBiome’s lead product candidate, a first-in-class, topical formulation incorporating a single strain of beneficial ammonia-oxidizing bacteria (AOB), Nitrosomonas eutropha, which was delivered by a spray twice a day.
Traditional clinical trials conducted at research-focused medical facilities typically include less than 10 percent of the non-Caucasian population yet Science 37’s “site-less” clinical trial model was able to recruit a 41% non-Caucasian participation rate for the AOBiome study, unlocking greater access to clinical research and addressing the lack of diversity represented in clinical trials today. Currently, only five percent of non-Caucasians are represented in all clinical trials and the percentage involved in cancer trials can be below two percent. Statistics such as these are a major driving force in Science 37’s creating the Metasite model to carry out telemedicine-based clinical research.
AOBiome selected Science 37 as a collaborative research partner to conduct the trial through a competitive bidding process amidst several other traditional CROs. In addition, Science 37 offered advantages in enrollment timing, diversity of patient population, and consistency of analysis given their centralized data review which resulted in a rapid and successful phase IIb study.
“We originally estimated that the phase IIb acne study would take significantly longer, requiring numerous clinical sites to complete,” said Todd Krueger, President, AOBiome. “We are proud to have innovated the study design with the Science 37 team. This is truly an industry-first and we are excited about the results of the partnership.”
Science 37 is currently using the Metasite model for decentralized clinical trials in therapeutic areas as diverse as headache, liver disease, cancer, and diabetes. “We are pleased to announce the positive results and improved enrollment performance for this trial,” said Co-founder and Chief Medical Officer, Belinda Tan, M.D., Ph.D. “We are looking forward to using this proven approach in several upcoming trials across different specialty areas to improve the patient experience in clinical research and connect a more diverse population of study volunteers to new, cutting-edge treatments.”