An estimated 30 million Americans suffer from Irritable Bowel Syndrome, which includes symptoms like abdominal pain, diarrhea and abdominal pain. Severe IBS has also been shown to contribute to mental health disorders including depression and anxiety.
One of the identified causes for IBS is dysfunction in the brain-gut connection, which refers to the portion of the nervous system that exists within the gut and controls digestion in collaboration with the brain. Research has shown that a mismatch or malfunction in this linkage can lead to IBS symptoms.
Existing pharmaceutical therapies are generally limited to specific subgroups of patients or have potentially severe side effects, leading some companies to turn to less traditional means for treatment.
One example is Chicago startup MetaMe Health which is developing a hypnotherapy-based digital therapeutic for the treatment of IBS.
Dubbed Regulora, the prescription digital therapeutic is a version of the Gut-Directed Hypnotherapy protocol developed by University of North Carolina psychologist Olafur Palsson which has shown the ability to improve IBS patients across a range of different disease subtypes.
The product delivers a standardized 12-week therapy that consists of seven half-hour sessions which bring patients into a state of deep relaxation and suggestibility before using metaphors and stories to create a sense of comfort and ease around the individual’s condition and symptoms.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
MetaMe recently raised a $3.8 million seed round led by Israeli venture capital firm LionBird Ventures, which will be used to conduct a pivotal trial for Regulora as part of its pathway towards FDA clearance. MetaMe CEO Tim Rudolphi said the company hopes to launch their their trial in the next couple months and wrap up the research next year.
MetaMe, which was founded back in 2016, initially was focused on connected licensed hypnotherapists with IBS patients.
However, the startup saw more opportunity in using technology as a way to actually deliver the therapy itself in a scalable product that can be used to collect data and build out a pipeline of digital therapeutics for GI disorders. Other indications targeted by the company include inflammatory bowel disease and gastroesophageal reflux disease.
Rudolphi recognizes the skepticism over hypnotherapy as part of medical practice, but contrasts the company’s clinically validated approach with the popular conception of the hypnosis.
“It’s not a kook waving a watch in front of you and making you cluck like a chicken,” Rudolphi said, pointing to dozens of published studies as evidence for its use in clinical practice.
Moving forward, Rudolphi said he is encouraged by the steps taken by companies like Express Scripts and CVS Health to launch digital health formularies and enable their reimbursement through similar means as existing pharmaceuticals.
Dr. David Spiegel, the Director of the Center for Integrative Medicine at Stanford University School of Medicine, said hypnotherapy has been shown to reduce pain and suffering for IBS patients without any of the adverse effects linked to existing pharmaceuticals.
Spiegel contends that what has limited access to gut-directed hypnotherapy in the past has been the limited number of professionals trained in the technique and added that new digital modalities can help address that disconnect.
“The need is there. When it does work, it helps and if it doesn’t work it doesn’t hurt,” Spiegel said. “We need new models and with the internet growing a new service delivery system, I think it is entirely possible we can make effective hypnotherapy available at distance.”
There are, as in anything else, deficiencies with hypnotherapy. For one, Spiegel estimated around a-third of adults can’t be hypnotized.
But even with that gap, Rudolphi says there is tremendous need among IBS patients who find their condition debilitating to their daily life. MetaMe’s clinical trial aims to enroll patients who are on existing medication regimens, as well as those who have not been prescribed any IBS drug.
“I’m actually shocked how receptive people have been, nobody walks away saying this makes no sense to me at all,” Rudolphi said. “Everyone says ‘you guys are onto something here’ and the overdrugging of America is part of that.”
Picture: JONGHO SHIN, Getty Images
