CHICAGO (October 31, 2019) — metaMe Health, Inc., a Chicago-based prescription digital therapeutics company committed to the treatment of gastrointestinal (GI) conditions such as Irritable Bowel Syndrome (IBS), today announced that the first subject has enrolled in a pivotal study to evaluate the efficacy and safety of an all-digital, self-administered behavioral therapy for the treatment of adult subjects with symptomatic IBS. This trial is a randomized, controlled, parallel-group study that will enroll subjects from across the United States.
The study is the next step in metaMe’s effort to obtain FDA clearance for its novel prescription digital therapeutic. “We see this all-digital therapeutic having the potential to be a primary treatment or as an option for patients who have failed to achieve relief from pharmaceutical and over-the-counter drugs,” said Charlie Baum, MD, chief medical officer for metaMe Health. “This pivotal trial is an important milestone for metaMe as we seek to provide a better and more accessible treatment option for patients who suffer from IBS.” metaMe expects to enroll approximately 380 patients, aged 18 years and older, to the study. Initial results are expected by the second half of 2020.
metaMe is collaborating with Curebase, a leader in distributed clinical research, to enable a highly remote clinical trial. Curebase enables metaMe to use modern research methods like remote informed consent, at-home patient-reported outcome (PRO) collection, remote risk-based monitoring, and direct collection of use engagement data from the investigational therapy itself. These technology innovations will enable high-resolution daily tracking of key endpoints and facilitate recruitment of a study cohort representative of the nearly 10 percent of Americans suffering from IBS.
metaMe was recently named to Chicago INNO’s 50 On Fire, a recognition of people and companies that are heating up the Chicago tech scene. To learn more about metaMe Health or to contact the company, visit www.metamehealth.com.
About metaMe Health
metaMe Health is committed to developing FDA-approved prescription digital therapeutics for the treatment of gastrointestinal conditions. The company was founded in 2016 by Chicago entrepreneur Daniel Bernstein, who has suffered from GI disorders including Irritable Bowel Syndrome (IBS) and Crohn’s disease since childhood. metaMe is currently developing a fully digital behavioral intervention for the treatment of IBS, which impact more than 30 million Americans.