IBS Digital therapeutic Parallel™ developed by King’s researchers gets approval in UK and US

Parallel™ is the first prescription only digital therapeutic to provide cognitive behavioural therapy (CBT)  to adults with irritable bowel syndrome (IBS) to receive the FDA Marketing Authorization in the US.  ParallelTM has also obtained a CE mark and been recommended for Evaluation in Practice by the National Institute for Health and Care Excellence (NICE).

The development of ParallelTM (formally known as Regul8) was led by Professor Rona Moss-Morris from Institute of Psychiatry, Psychology & Neuroscience, King’s College London and the NIHR Maudsley BRC, drawing in part from earlier work conducted by Trudie Chalder, Professor of Cognitive Behavioural Psychotherapy and colleagues also from King’s College London.

ParallelTM is a three-month tailored, interactive digital programme focused on altering the Brain-Gut axis.  The programme helps patients understand the changes in their physiology that contribute to their symptoms and how changing certain behaviours, thoughts and emotional responses can help to regulate the gut.  ParallelTM has no known side effects and is intended to be used with other IBS treatments.

In 2020 King's College London entered into a licensing agreement with US based Mahana Therapeutics and ParallelTM became the first digital product to be licenced by King’s Commercialisation Institute.

Rona Moss-Morris, Professor of Psychology as Applied to Medicine and Head of Psychology at Institute of Psychiatry, Psychology & Neuroscience, King's College London, who has continued to work with Mahana to further develop the product and obtain the regulatory approvals 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 FDA authorisation and a CE mark.  This is the first crucial step to ensuring we can make the product available to as many people with IBS who may benefit as possible "

In 2019 results on the effectiveness of ParallelTM were published in the largest trial of cognitive behavioural therapy (CBT) in irritable bowel syndrome led by University of Southampton, King’s College London and NIHR Maudsley BRC researchers.

This showed a significantly greater benefit for both therapist-delivered CBT (led my Professor Trudie Chalder) and web-delivered CBT (led by Professor Rona Moss-Morris) than current treatment as usual. Both forms of CBT were effective in reducing the severity and impact of symptoms.  Web based CBT was shown to be the more cost-effective treatment. 

Professor Hazel Everitt, GP and Professor of Primary Care Research, Faculty of Medicine, University of Southampton who led the trial 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 ParallelTM could give providers a new tool to help their IBS patients reduce symptom severity and improve the quality of their daily lives.”

Mahana Therapeutics

Mahana is a global leader in prescription digital therapeutics for gastrointestinal conditions. ParallelTM is Mahana's debut product and is the first digital therapeutic authorized for marketing by the U.S. FDA and CE Marked for the European Union to reduce the severity of symptoms of IBS.

 “This is a fantastic breakthrough for the greater than 35 million people in the U.S. who suffer from IBS. Many of these patients find current treatment offerings inadequate or inaccessible,” said Robert Paull, co-founder of Mahana Therapeutics.

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

For more information see the Mahana Therapeutics press release.

ParallelTM Indication For Use and Important Safety Information

ParallelTM is a prescription-only digital therapeutic device intended to provide cognitive behavioural therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). ParallelTM is indicated as a 3-month treatment for patients with IBS. ParallelTM treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.

Tags: Novel Therapeutics - Digital Therapies -

By NIHR Maudsley BRC at 1 Apr 2021, 10:00 AM

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