Mahana Therapeutics, the global leader in prescription digital therapeutics for gastrointestinal conditions, today announced that the U.S. Food and Drug Administration (FDA) has authorized marketing for Parallel™, the first prescription-only digital therapeutic (PDT) intended for use in adult patients to reduce the severity of IBS symptoms. The authorization comes after FDA granted Mahana Therapeutics’ De Novo request for classification of Parallel.
IBS is a disorder of the gut-brain interaction. Parallel is a three-month digital program that teaches adults cognitive behavioral therapy (CBT) skills to influence gut-brain communication. Parallel works by helping patients change certain behaviors and thoughts that can contribute to IBS and has been clinically proven to reduce the severity of IBS symptoms. Parallel has no known side effects and is intended to be used with other IBS treatments.
“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. “Inspired by these patients, we’ve been dedicated to building a best-in-class product, driven by clinical evidence, and guided by the world’s leading experts, to supplement existing IBS treatments. Now that we have FDA marketing authorization we look forward to bringing this treatment to patients.”
The FDA submission was supported by a randomized, controlled trial of 558 patients with IBS. At three months, the group of participants enrolled in a digital CBT program experienced a clinically meaningful reduction in the severity of their IBS symptoms.
“Parallel provides adult patients suffering from any sub-type of IBS with a clinically-validated, digitally-delivered, cognitive behavioral therapy-based complementary treatment,” said Dr. Emeran Mayer, a Distinguished Professor at UCLA, pioneer of medical research on gut-brain interactions, and a member of Mahana’s clinical advisory board. “CBT has increasingly been incorporated into gastrointestinal patient care, and this digital model increases access to this important treatment approach. Prescription digital therapeutics, working in ‘parallel’ with medications and other treatments, represent an exciting new frontier in medicine.”
Mahana also announced today that Steven Basta will join the company as chief executive officer, succeeding co-founder Robert Paull, who has served in this role through this early stage and will remain on as a member of the board of directors. Steven brings 20 years of commercial medical technology experience, leading multiple medical device and biopharma companies through commercial product introductions and global growth. Most recently, he was the CEO, president, and director of Menlo Therapeutics, Inc. (now known as VYNE Therapeutics, Nasdaq: VYNE), a dermatology biopharmaceutical company. Prior to that, he was CEO of AlterG, Inc. and BioForm Medical, Inc. (Nasdaq: BFRM).
“I’ve been so impressed by Rob and the Mahana team’s deep commitment to developing a new treatment option for IBS patients,” said Basta. “We now have all the pieces in place to grow rapidly within the emerging prescription digital therapeutics space, and I’m thrilled to be coming on board at this key inflection point.”
This latest news reflects a monumental year for Mahana, which began with the announcement of a worldwide exclusive license to Parallel and a collaboration agreement with King's College, London. Mahana was founded in 2018 and has raised funding from Lux Capital, JAZZ Venture Partners, and Luminous Ventures.
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Mahana Therapeutics is the global leader in prescription digital therapeutics for gastrointestinal conditions. Parallel™, Mahana’s debut product, is the first digital therapeutic authorized for marketing by the U.S. FDA to reduce the severity of symptoms of irritable bowel syndrome (IBS), a condition that affects one in 10 people worldwide. Guided by a commitment to rigorous clinical evidence and drawn from experience as patients ourselves, Mahana’s team of experienced entrepreneurs, physicians, psychologists, engineers, and designers are dedicated to using software to treat and manage chronic conditions that affect so many. Founded in 2018, Mahana is located in San Francisco and London. For more information, visit www.mahanatx.com or follow us @mahanatx.
Parallel™ was formerly known as Regul8. Regul8 was originally developed by Rona Moss-Morris Ph.D, Head of Psychology Department, King’s College London (KCL) in collaboration with Trudie Chalder, Ph.D, Professor of Cognitive Behavioural Psychotherapy and Alice Sibelli, Ph.D. at KCL and Dr. Hazel Everitt, Professor of Primary Care Research, University of Southampton. Initial clinical funding support was provided by the UK National Institute for Health Research (NIHR).
Parallel is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a 3-month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
PARALLEL is intended for patients whose primary language is English.
PARALLEL is intended only for patients who have a desktop or laptop with a web browser and internet connectivity and be familiar with the use of web-based applications.
PARALLEL is not to be used to communicate any emergency, urgent or critical information. Parallel does not include features that can send alerts or warnings to your clinician. If you have feelings or thoughts of harming yourself or others, please dial 911 or go to the nearest emergency room.
PARALLEL is not a substitute for your medications. You should continue to take your medications as directed by your provider.
PARALLEL is not intended to be used as standalone therapy for IBS and does not replace care by your provider.
PARALLEL is meant to be used in conjunction with other IBS treatments you may be using.
This press release does not include all the information needed to use Parallel safely and effectively. Please see the full Patient & Clinician Brief Summary Instructions for Parallel for more information.