Mahana Therapeutics:
From the Patients, For the Patients

By Robert Paull

My motivation to create Mahana Therapeutics came from my very personal patient journey; a journey that continues today. As I’ve shared my story with our employees, others on our team have shared their personal experiences dealing with GI issues and other medical conditions. This empathy is what motivates us every day and what has attracted some of the world’s experts to our team. Thank you to the supporters who have helped me over the years and who continue to support us on this journey.

Inspiration for a startup company can come in a variety of ways. Sometimes a company can emerge from a major technical breakthrough, like the invention of recombinant DNA leading to the creation of Genentech in the late 1970s. Other times, it comes out of the search for a solution to an unsolved problem, like storing nuclear waste in a cleaner, safer way (the mission of Lux Capital creation Kurion, which helped to clean up Fukushima). But sometimes, the reason for starting a company arises from personal pain. I created Mahana from a deeply challenging, personal journey that my family and I are still going through today.  

CHRONIC GASTROINTESTINAL CONDITIONS RESULT IN FAMILY SUFFERING

For more than eight years, I’ve been trying my best as a caregiver to help someone I love dearly cope with a serious gastrointestinal condition. This condition has led to severe and frequently debilitating constipation. My family member has Chronic Idiopathic Constipation (CIC), a form of constipation where doctors don’t know the cause (“idiopathic”). CIC is believed to affect 35 million people in the United States1.

Over the years, with the help of some of the best gastrointestinal motility specialists in the world, we explored over 20 different diagnoses or root causes. We’ve even tried crowdsourcing to find answers. To this day, we still don’t know the cause of this condition. For years, my family’s daily life has been incredibly challenging. Our loved one’s experience with CIC has led to the inability to stool for as many as six, seven, even nine days despite regular use of laxatives, osmotic agents, and suppositories. These medications have been used at times in combination with elimination diets and dietary changes recommended by registered dieticians. CIC has led to a domino effect of difficult and distressing issues including diagnoses at times of megacolon and possibly dolichocolon (an elongated colon).


We’ve dealt with abdominal pain so excruciating that what typically might be a 15-minute car ride could take hours requiring stopping multiple times to alleviate the pain from sitting. Abdominal distention that literally looks like your stomach is going to explode if it stretches any further. Waking multiple times throughout the night for years to adjust our loved one or help them get the gas out as they had woken in pain. Endless hours on the toilet, often sitting for over an hour at a time, straining and pushing to get stool out despite having no urges to stool at all and often with no success.


This has been our daily life for over the past eight years. On top of that, we’ve tried over 18 different medications (I counted) often with little to no benefit and at times unpleasant side effects. We’ve undergone multiple invasive tests to rule out or test for anatomical anomalies, obstructions, inflammation, and other neurological conditions. We’ve had to become knowledgeable about how to fight for accommodations in the public school system to deal with the daily implications of this condition so our loved one can attend school, and not be penalized emotionally, physically, or academically for their medical condition.

The journey for us has been extremely confusing and lonely. It caused me to recalibrate my life and dedicate years of research (reading hundreds of medical papers, talking to doctors, talking to patients) to try to help my loved one. I feel fortunate that I’ve had the opportunity to access these doctors and treatments and realize that not everyone does.  I’ve met kids, parents, and adults who are suffering from other GI conditions such as Crohn’s Disease and Ulcerative Colitis, arguably even more debilitating than what we’ve been going through. Along the journey, I’ve learned that for adults:


  • In a survey of over 513 IBS sufferers, 46% of IBS-D patients agreed with the statement “I’m willing to try anything to help manage my IBS.”2
  • In a survey of over 1,966 IBS sufferers, on average, patients reported they would give up 25% of their remaining life (approximately 15 years) to live symptom free.3
  • Other studies have shown that between 40-60% of people with IBS suffer from psychological symptoms that include depression, anxiety disorders, and post-traumatic stress disorder.4,5,6
  • In IBD, upwards of 70% of patients experience pain, sometimes debilitating, as part of the disease course and for upwards of 52% of patients, pain can be a longstanding problem. 7
  • These sometimes uncontrollable aspects of pain can be associated with profound anxiety.8


While GI conditions can be really challenging for adults, they can be especially devastating for kids. Various studies have found that:  

  • Up to 25% of young people with IBD have depression.9
  • Childhood-onset IBD has been associated with increased risk of suicide attempts.10
  • Surveys have shown upwards of 61% of under 18 year olds have felt IBD affects their ability to perform to their full educational potential.11
  • Constipation, which affects 1-30% of kids worldwide and accounts for 10-25% of pediatric gastroenterology visits,12 can contribute to a negative effect on quality of life that persists into adulthood in upwards of 25% of patients.13

PSYCHOLOGICAL-BASED INTERVENTIONS HELPED REDUCE SOME OF THE SYMPTOMS AND IMPROVED PART OF THE ANXIETY AND DEPRESSION FELT BY THE ENTIRE FAMILY

One of the bright spots in this journey, in addition to the two amazing GI doctors who have been helping us over the years, was the experience we had with a psychologist who has deep expertise in helping gastrointestinal patients cope with conditions such as severe constipation. We were taught new skills: behavioral changes that, in addition to standard of care (i.e., the medications the GI doctors prescribed), had reportedly helped reduce symptoms and improved the day-to-day quality of life in other patients dealing with CIC. These behavior changes have significantly helped us, too. These psychology-based approaches led to increases in stool frequency, decreases in abdominal distention and belly pain. This was the light bulb moment for me in wanting to launch Mahana to help patients like my loved one and families like ours.

THE CHALLENGE: ACCESS TO QUALIFIED MENTAL HEALTH RESOURCES

Part of the challenge however, is access to these psychological interventions. After having a positive experience with a psychologist who specializes in gastrointestinal conditions, I began researching the field of “psychogastroenterology,” the intersection of GI + psychology and the “brain-gut connection.” The more I read, the more excited I got about the emerging clinical evidence. Psychology-based treatments/interventions have been studied in many clinical trials at some of the world’s best academic institutions:

  • Short-term and Long-term Efficacy of Psychological Therapies for Irritable Bowel Syndrome: A Systematic Review and Meta-analysis14which evaluated over 41 clinical trials and concluded that “Psychological therapies reduce GI symptoms in adults with IBS. These effects remained significant and medium in magnitude after short-term and long-term follow-up periods.”
  • I learned about the great work coming out of the Rome Foundation, leaders like Laurie Keefer PhD and the increasing efforts of the American Gastroenterology Association of Incorporating Psychogastroenterology Into Management of Digestive Disorders.15
  • I found encouraging studies out of Jeffrey Lackner PhD (University of Buffalo), which demonstrated in his large NIH-funded IBSOS study that minimal contact self-administered CBT showed improvements in IBS patient symptom severity.
  • Over the last 15 years, GI psychology experts like Rona Levy PhD (University of Washington - Mahana advisor); Miranda van Tilburg PhD (Campbell University - Mahana advisor); Brjann Ljotsson PhD, Marianne Bonnert PhD, and Maria Lalouni PhD (Karolinska Institute); Rona Moss-Morris, PhD (King’s College - Mahana Advisor); and more have published clinical studies showing that integrating complementary psychological approaches to treat GI conditions can lead to improved outcomes for patients.  


However, despite the promising clinical and research progress, access to these interventions is severely limited. In many rural areas, there simply aren't psychologists nearby. While tele-mental health offers some exciting new options, these are not mainstream. Even in many urban or suburban areas, access to a therapist can sometimes take weeks if not months. This is not just a problem in the U.S. The United Kingdom has been dealing with severe delays in getting patients mental health support, sometimes years of delays.16 Fortunately, the U.K. recognizes this and continues to expand unique and successful initiatives like IAPT (Improving Access to Psychological Therapies).


Even if you can get access to a therapist, reimbursement rates (here in the U.S.) are sometimes very low causing many therapists to only take private pay. Paying out of pocket is often not an option for many patients. To make matters worse for patients suffering from GI conditions, there are very few psychology experts who specialize in GI conditions (at recent industry conferences, that number was estimated to be around 150). With upwards of 40 million Americans suffering from IBS, 3-5 million suffering from Inflammatory Bowel Disease, and 35 million suffering from Chronic Idiopathic Constipation, we need some new ways to increase access to clinically proven psychology-based interventions.    

ENTER DIGITAL THERAPEUTICS, A COMPLEMENT TO MEDICATIONS AND FACE-TO-FACE MENTAL HEALTH INTERVENTIONS

Collaboratively designed (among patients, providers, payers, and maybe even pharma), clinically validated with the gold standard -- randomized controlled trials (RCTs), regulatory-body cleared/approved, and physician-prescribed digital treatments for gastrointestinal conditions are one scalable option to address this access problem. These are not a replacement for drugs. These are also not a replacement for therapists, who serve a valuable role for patients. But digital treatments are intended to be adjunct, complementary, or “Parallel” (our IBS product name) to standard of care.

What if your doctor could prescribe you a personalized treatment that was non-invasive (i.e., an app or website) and had been demonstrated to be safe, efficacious, and even enjoyable to use? And what if that treatment not only reduced your symptoms or symptom severity but also improved your quality of life while living with your GI condition?

This is Mahana’s mission.  

We have a long way to go (in the U.S. we’re an investigational, not FDA-cleared, product) but fortunately, over the past few years, new pathways have opened that make Mahana’s mission and vision more possible.  The FDA has a new category for these types of “prescription apps” or PDTs (Prescription Digital Therapeutics), namely “Software as a Medical Device” or SaMD. Some of the first products are already on the market (such as Pear Therapeutics’ RESET and RESET-O for substance abuse disorder). Mahana is committed to developing products under the various FDA guidelines that govern this new field and we’re working hard to prove our products are safe, efficacious, accessible, and affordable for patients.


My very personal journey has inspired me to bring together a like-minded team that wants to develop clinically validated software treatments for gastrointestinal patients. We believe digital therapeutics play an important, complementary role in offering patients a comprehensive approach to improving living with a GI condition. If Mahana is able to help patients reduce the severity of their symptoms and suffering like my family has felt over the last eight years, then I know our mission is well worth it.  We’re excited to share our progress in the months and years to come.

1  Am J Manag Care. 2019 Mar;25(4 Suppl):S55-S62.
2  Törnblom H, Emmanuel A, Goosey R, et al. Understanding Symptom Burden and Attitudes in Patients with Irritable Bowel Syndrome with Diarrhea: Results from a Patient Survey. Gastroenterology. 2017;152(5):S745-S46.
3 Drossman DA, Morris CB, Schneck S, et al. International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. J Clin Gastroenterol. 2009a;43(6):541-50.
4
Ballou S, Bedell A, Keefer L. Psychosocial impact of irritable bowel syndrome: A brief review. World J Gastrointest Pathophysiol. 2015;6(4):120-3.
5
Sibelli A, Chalder T, Everitt H, et al. A systematic review with meta-analysis of the role of anxiety and depression in irritable bowel syndrome onset. Psychol Med. 2016;46(15):3065-80.
6
Weaver KR, Melkus GD, Henderson WA. Irritable Bowel Syndrome: An evidence-based review of new diagnostic criteria and treatment recommendations. American Journal of Nursing. 2017;117(6):48-55
7
Zeitz J, et al. Pain in IBD Patients: Very Frequent and Frequently Insufficiently Taken into Account. PLoS One. 2016; 11(6):e0156666.
8
Docherty MJ, Jones RC 3rd, Wallace MS. Managing pain in inflammatory bowel disease.Gastroenterol Hepatol (N Y). 2011 Sep; 7(9): 592–601.
9
Szigethy E, McLafferty L, Goyal A. Inflammatory bowel disease. Pediatr Clin North Am 2011; 58: 903-20.
10
JAMA Pediatr. 2019;173(10):969-978. doi:10.1001/jamapediatrics.2019.2662
11
https://www.ueg.eu/press/releases/ueg-press-release/article/incontinence-and-crippling-fatigue-disrupts-education-and-ruins-job-prospects-for-children-with-ibd/
12
Am Fam Physician. 2014 Jul 15;90(2):82-90.
13
Pediatrics July 2010, 126 (1) e156-e162; DOI: https://doi.org/10.1542/peds.2009-1009
14
Clin Gastroenterol Hepatol. 2016 Jul;14(7):937-947.e4. doi: 10.1016/j.cgh.2015.11.020. Epub 2015 Dec 22.
15
Gastroenterology. 2018 Apr;154(5):1249-1257. doi: 10.1053/j.gastro.2018.01.045. Epub 2018 Feb 1.
16
https://www.theguardian.com/society/2018/oct/09/mental-health-patients-waiting-nhs-treatment-delays

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