Digital therapeutic for IBS receives CE mark

Mahana Therapeutics, a digital therapeutics firm, has obtained a CE mark for its flagship product Parallel. Parallel is a prescription-only digital therapeutic (PDT) intended to reduce the severity of irritable bowel syndrome (IBS) symptoms in adult patients. 

The programme was developed in collaboration with expert researchers under the leadership of Professor Rona Moss-Morris, Ph.D of King’s College, London and Professor Hazel Everitt of the University of Southampton. Parallel has also been recommended for Evaluation in Practice by the National Institute for Health and Care Excellence (NICE).

IBS is a disorder of the gut-brain interaction. Parallel, formerly known as Regul8, was developed by a team of leading UK psychologists to teach adults cognitive behavioural therapy (CBT) skills to influence gut-brain communication. Parallel’s three-month programme works by helping patients change certain behaviours and thoughts that can contribute to IBS and has been clinically proven to reduce the severity of IBS symptoms.

Professor Rona Moss-Morris, professor of psychology as applied to medicine and head of psychology at King’s College, London, who led the development of the initial Parallel programme, said: “We entered into this collaboration with Mahana because of our shared commitment to developing clinically-validated, cost-effective treatment options that address IBS symptoms. I am excited and proud that the result of our work together has met the high health and safety standards needed to obtain a CE mark.” 

In the UK alone, IBS affects up to 22% of the population and costs the NHS more than £200 million annually. More than half of IBS patients don’t feel that their prescription drugs alone provide effective relief from IBS. Those suffering from IBS often experience a range of symptoms, both physical and psychological. Parallel is intended to be used in conjunction with other IBS treatments to reduce the severity of these symptoms. 

Professor Hazel Everitt, GP and professor of primary care research, Faculty of Medicine, University of Southampton, said: “I see many patients in my clinical practice who continue to struggle with ongoing IBS symptoms despite trying medications. This led me to undertake research to provide rigorous evidence for new options. Randomised controlled trials, including the one I led, have shown that CBT designed specifically for IBS can meaningfully reduce the severity of IBS symptoms. Our collaboration with Mahana was born from the vision that innovative, clinically-validated approaches, alongside the latest practice guidelines, could make a real difference to patients. Digital therapeutics like Parallel could give providers a new tool to help their IBS patients reduce symptom severity and improve the quality of their daily lives.”

This news comes on the heels of Mahana obtaining FDA authorisation for Parallel in the United States. It also follows a year of significant milestones, including the announcement of a worldwide exclusive license to Parallel and a collaboration agreement with King's College, London.

Steven Basta, Mahana CEO, said: “Mahana was founded with the needs of patients at its heart. Earning a CE mark certification represents an exciting new phase for our work to deliver innovative treatment options to patients struggling with IBS symptoms.”