King’s College London Licenses its Investigational Digital Therapy for Irritable Bowell Syndrome to SF-Based Startup

Kings College London Licenses its Investigational Digital Therapy for Irritable Bowell Syndrome to SF-Based Startup TrialsiteN

Kings College London, a leading research center and one of the oldest and most prestigious universities in England, has inked a worldwide exclusive licensing deal for the very new innovative digital therapeutic intellectual property (IP) it developed for the treatment of irritable bowel syndrome (IBS). Based on the results of a successful clinical trial, the university licensed its IP to San Francisco startup Mahana Therapeutics.

Background

Kings College London spent nearly two decades developing and clinically testing a digital cognitive behavioral therapy (CBT) based self-management manual for IBS in primary care with minimal therapist contact. In collaboration with research partners at Southampton and through funding via NIHR RfPB, the team was able to develop a web-based version of this treatment approach called Regul8. More background information can be reviewed here.

Irritable Bowel Syndrome

In the UK, 10-22% of the population is impacted. Between 10-15% of the U.S. population deals with this condition, and it is prevalent worldwide in many cases in far higher rates. Current treatment relies on a positive diagnosis reassurance, lifestyle advice and drug therapies but for many suffer on going despite medications.

The Study

The parties reported in a press release that a multi-center randomized controlled trial (RCT) involving 558 patients was to be “the largest clinical trial ever conducted demonstrating the clinical safety and efficacy of a digital CBT product for IBS.” The results, published in the journal Gut, produced evidence that the web-based CBT evidenced substantial and durable IBS symptom severity improvements versus the standard of care. Moreover, investigators reported reductions in patient anxiety and depression during the study and thereafter up to 12 months.

Lead Research/Investigator

Professor Rona Moss-Morris, Health of Psychology Department, Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London

Trudie Chandler, Professor of Cognitive Behavioral Psychology, King’s College London

Dr. Alice Sibelli, King’s College London

Hazel Everitt, GP, Professor of Primary Care Research, Faculty of Medicine, University of Southampton