metaMe Health Receives FDA Clearance for Regulora®, the First FDA Approved Treatment Specifically for Abdominal Pain Due to Irritable Bowel Syndrome (IBS)

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metaMe Health is committed to developing FDA-approved digital prescription therapeutics (PDTs) for the treatment of gastrointestinal conditions.

IBS is a widespread and debilitating disease that results in part from poor communication between the brain and the gut. Treatments like Regulora aim to normalize brain-gut communication.

metaMe Health, Inc. today announced that the United States Food and Drug Administration (FDA) has cleared Regulora®, the first FDA-approved treatment of any type specifically for abdominal pain associated with irritable bowel syndrome ( SCI) in adults.

The treatment of abdominal pain associated with IBS is about to bring about a fundamental change in clinical practice. The COVID-19 pandemic has prevented patients from engaging in many activities of daily living and has resulted in increased pain and psychological distress due to IBS-related symptoms (1). This has created a growing unmet medical need for self-administered behavioral therapy options to treat IBS.

Regulora offers behavioral therapy based on gut-directed hypnotherapy (GDH) through a convenient smartphone app that can be used at home. GDH helps patients with their IBS symptoms by promoting healthier control of digestive tract function and providing therapy designed to influence the sensation of pain (2). So far, GDH has only been provided in person by licensed therapists.

“The FDA clearance of Regulora, our first PDT, is a major achievement for the company,” said Tim Rudolphi, CEO of metaMe Health. “We look forward to expanding access of this proven therapy to patients with all three subtypes of IBS. “

Regulora offers a valuable treatment option for patients with IBS and their doctors. “Decades of studies show that GDH administered in person by therapists is effective in treating the symptoms of IBS. However, few therapists are trained in this highly specialized technique, so this option has not been available to most patients. Regulora now makes this treatment available to any adult with IBS through their GP or gastrointestinal specialist, and also makes it much more convenient as no visit to a therapist is necessary, ”said Dr Olafur Palsson, professor of medicine in the division of gastroenterology and hepatology. at the University of North Carolina.

Irritable Bowel Syndrome is a chronic disease of the lower gastrointestinal tract that affects 10-15% of adults in the United States. IBS accounts for nearly 3.5 million doctor visits in the United States each year and is one of the most common diagnoses made by gastroenterologists (3).

“IBS is a widespread and debilitating disease that results in part from poor communication between the brain and the gut. Stress and other external factors can contribute to normal gut signals being amplified and misinterpreted by the brain like abdominal pain Treatments like Regulora aim to normalize brain-gut communication, ”said Dr. Neil Sengupta, assistant professor of gastroenterology at the Pritzker School of Medicine at the University of Chicago.

About Regulora

Regulora is a digital therapeutic mobile application that downloads to an Apple or Android mobile device. Regulora offers seven 30-minute Gut-Directed Hypnotherapy (GDH) -based Remote Behavior Therapy (GDH) sessions that are administered over a 12-week period. Before Regulora, treatment with GDH was only provided by a trained clinician in a medical clinic. With Regulora, GDH video processing sessions are presented on your mobile device.

GDH provided in the clinic by trained therapists has been shown in numerous studies to help patients improve their IBS symptoms, including abdominal pain, constipation, diarrhea, and bloating. According to a 2020 systematic review of scientific research, among behavioral treatments for IBS, GDH has strong evidence of effectiveness and produces long-term beneficial effects (4).

Clinical evidence to support Regulora

Regulora has been evaluated in a multi-site, randomized, controlled, blinded clinical trial involving 362 evaluable subjects. Two of the three primary endpoint analyzes of abdominal pain achieved clinically significant separation from the control arm. In addition, 68% of subjects assigned to Regulora said they were overall satisfied with the treatment and 87% would recommend Regulora to someone else with IBS. No serious adverse events have been associated with Regulora. About 1% of study participants experienced non-serious adverse events, including abdominal pain, constipation, fatigue, or headache. 87% of subjects assigned to Regulora were on treatment.

Indications for use of Regulora

Regulora is a digital prescription therapy device only intended to provide bowel-directed hypnotherapy behavioral therapy for adults 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Regulora is indicated as a 3 month treatment for patients with abdominal pain due to IBS and is intended for use with other treatments for IBS.

About IBS

Irritable Bowel Syndrome is a chronic disease that affects 10-15% of adults in the United States. The central symptom is abdominal pain, which is accompanied by diarrhea (SCI-D), constipation (SCI-C) or mixed periods (SCI-M). IBS has a severe impact on the quality of life; According to a survey of nearly 2,000 patients, people with IBS report that they spend 25% of their remaining life (on average 15 years) living symptom-free. Symptoms are mediated by disruption of sensory signaling and motility between the brain and gut and exacerbated by cognitive, behavioral, affective, and physiological factors. The annual cost of treating IBS in the United States has been estimated to be between $ 1.7 billion and $ 10 billion in direct costs, with total indirect costs of $ 20 billion (6).

The references

(1) Kamp et al. J Clin Gastroenterology. 2021; PMID: 33780216.

(2) Palsson OS. Am J Clin Hypn. 2015 ; PMID: 26264539.

(3) Facts about IBS from the International Foundation for Gastrointestinal Disorders (IFFGD) (https://aboutibs.org/what-is-ibs/facts-about-ibs/statistics/).

(4) Black et al. Intestine. 2020; PMID: 32276950.

(5) Gastrointestinal Society IBS Global Impact Report 2018 (https://badgut.org/wp-content/uploads/IBS-Global-Impact-Report.pdf).

(6) Hulisz, D., J Managed Care Pharm, 2004. PMID 15298528.

About metaMe Health, Inc.

metaMe Health is committed to developing FDA-approved digital prescription therapeutics (PDTs) for the treatment of gastrointestinal conditions. Prescription Digital Therapeutics are software applications that provide patients with evidence-based therapeutic interventions to prevent or treat a medical disorder or disease. They are used independently or in conjunction with medications or other therapies to optimize patient care and health outcomes. PDTs are developed under rigorous conditions with clinical trials, FDA clearance, and availability only by prescription from a physician.

For more information or for investor inquiries, send an email to [email protected]

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