Agreement with Dr. Sarah Kinsinger and Dr. Olafur Palsson gives metaMe Health global rights to develop and market the digital therapeutic
- Functional dyspepsia, a chronic disorder of the upper gastrointestinal tract, is estimated to affect 10-20% of people who seek health care for indigestion symptoms, according to the Cleveland Clinic
- metaMe Health, a leader in Prescription Digital Therapeutics (PDT), is the developer of gut-directed hypnotherapy Regulora®, which in 2021 became the first FDA-authorized PDT specifically for abdominal pain associated with irritable bowel syndrome in adults
CHICAGO, January 4, 2023 – metaMe Health, Inc., a Prescription Digital Therapeutics (PDT) company, today announced that it has licensed exclusive worldwide rights to use and distribute a newly developed gut-directed hypnotherapy (GDH) protocol for the treatment of functional dyspepsia (FD), a chronic disorder of the upper gastrointestinal tract that currently lacks substantially effective therapy options.
The protocol, which is the first fully standardized hypnosis treatment for FD, demonstrated excellent feasibility and resulted in significant improvement in FD symptoms during a 2021 pilot trial. It was developed by Sarah Kinsinger, Ph.D., associate professor and director of behavioral medicine for digestive health at Loyola Medicine in Chicago, and Olafur Palsson, Psy.D., professor of medicine at the University of North Carolina at Chapel Hill. metaMe Health licensed the GDH protocol directly from Drs. Kinsinger and Palsson, who will work with the company to conduct a large pivotal trial, with the aim of eventual submission to the U.S. Food and Drug Administration (FDA) for clearance and commercialization.
metaMe Health is a pioneer in prescription-based therapeutics utilizing hypnosis. It is the developer of Regulora®, which in 2021 became the first FDA-authorized PDT specifically for abdominal pain associated with irritable bowel syndrome in adults. Like Regulora®, the newly licensed GDH protocol for FD is a fully automated hypnosis audio treatment program that does not require therapist or clinician involvement in administering treatment. FD, one of the most common functional gastrointestinal disorders, is estimated to affect 10-20% of people who seek health care for indigestion symptoms, according to the Cleveland Clinic.
“metaMe Health is thrilled to partner with Drs. Palsson and Kinsinger for the development of a prescription digital therapeutic that could potentially bring relief to the millions of people who suffer from functional dyspepsia,” said Tim Rudolphi, chief executive officer of metaMe Health. “With a product pipeline that includes digital hypnotherapy PDTs for heartburn and ulcerative colitis, and with Regulorafor IBS pain already FDA-cleared and commercialized, developing an FD intervention fits perfectly with our focus on gastrointestinal health and our expertise in bringing PDTs from concept to market.”
The initial single-center trial of the gut-directed therapeutic for FD enrolled 23 patients, who completed seven bi-weekly audio-recorded hypnosis sessions over a three-month period. Nearly all participants (96%) completed the treatment program and three-month follow-up. Intention-to-treat analyses showed significant improvement at both end of treatment and three-month follow-up in dyspepsia symptom severity and quality of life, as well as in gut-specific anxiety and psychological distress.
“The results of this first study, showing large reduction on average in overall FD symptoms, indicate that the intervention has high potential as adjunctive therapy for functional dyspepsia and warrants further investigation in a randomized controlled trial,” said Dr. Palsson. “Dr. Kinsinger and I are therefore excited to partner with metaMe Health for that purpose, as it is the only company that has been able to scientifically validate and bring to market a hypnosis-based FDA-cleared digital therapeutic for a gastrointestinal health problem.”
Dr. Kinsinger added that “GDH is gaining popularity among patients and providers and this licensing arrangement and collaboration with metaMe Health is an outstanding opportunity to enable this convenient self-administered treatment to become widely available to patients with FD. In our pilot testing at Loyola Medicine, we found that this innovative treatment approach was highly appealing to patients and they were very satisfied with the automated format, which allowed them to implement treatment on their own.”
About Functional Dyspepsia
Functional dyspepsia refers to chronic indigestion – with symptoms such as stomach ache, nausea and a feeling of fullness or bloating during and after meals – when no obvious cause for symptoms can be found. Considered one of the most common functional disorders of the gastrointestinal tract, it is estimated to affect 10% of all U.S. adults, and at least 10-20% of people who seek health care treatment for indigestion symptoms, according to the Cleveland Clinic.
About metaMe Health
metaMe Health, Inc., is a U.S. company that develops Prescription Digital Therapeutics (PDT) for the treatment of common chronic conditions. metaMe Health’s initial digital solutions aim to relieve the pain and disruption of everyday life experienced by millions suffering from gastrointestinal disorders. By allowing patients to be prescribed treatment confidentially and to undergo treatment privately at home, metaMe Health offers non-drug options that provide relief in a familiar, comfortable environment. For additional information, please visit metamehealth.com or follow @metaMeHealth on Twitter and metaMe Health on LinkedIn.
MJH Life Sciences®