Mahana Therapeutics (https://www.mahanatx.com/), a Luminous Ventures portfolio company, has recently announced that the FDA has granted marketing authorization for its first product, Parallel™, a prescription digital therapeutic (PDT) intended for use in adult patients to reduce the severity of Irritable Bowel Syndrome (IBS) symptoms. This is a landmark achievement: the first FDA-cleared PDT for gastrointestinal conditions and, by our estimation, one of only six FDA cleared PDTs.
PDTs are a new class of treatments. They are usually software programs (websites or smartphone-based products) that deliver evidence-based therapeutic interventions to prevent, manage or treat a medical disorder or disease. These products not only require rigorous clinical studies to prove their benefit but also need to be developed under an extensive software quality management system. Over the last few years, this space has emerged as a subset of the broader digital health sector. PDTs are frequently seen as “Software as a Medical Device” (SAMD) in the eyes of regulatory agencies such as the FDA or MHRA and have become an area of increased interest within digital health. 2020 saw the first real cohort of initial regulatory clearances, with Akili securing marketing authorization for its EndeavorRx product focussed on ADHD and Pear Therapeutics now having secured clearances for three products targeting addiction and insomnia.
Parallel uses cognitive behavioural therapy to influence gut-brain communication in patients with IBS and has been clinically proven to reduce the severity of IBS symptoms. IBS affects some 35 million patients in the United States alone and many patients find existing treatments ineffective. Globally, IBS affects about 1 in 10 people, with approximately 50 million people in Europe, and 10-12 million people here in the U.K. suffering from it. Mahana’s commitment to the U.K. (the original IP was generated at King’s College, London) was also one of the compelling investment drivers for us and we look forward to sharing further announcements related to the significant traction they’ve achieved outside of the U.S. soon.
Mahana’s team is world class, combining experience across traditional biotech, software development and product, clinical, regulation and quality. The company was founded by Rob Paull, previously founding CEO of Harvard Medical School spinout Genocea Biosciences (NASDAQ: GNCA) and founding CEO of Johns Hopkins spinout Kala Pharmaceuticals (NASDAQ: KALA). Rob and his co-founder, Simon Levy, have built the type of high performing team that we like to partner with at Luminous. The execution has been strong, with this initial FDA clearance achieved with a fraction of the funds and time compared with Mahana’s peers. We were delighted to partner with both Lux Capital and JAZZ Ventures on the Series A earlier this year, and look forward to working with the team in the years to come to create the world’s leading PDT platform.
For us at Luminous, PDTs are a hugely exciting area, offering the ability to positively improve the lives of millions of patients through a software enabled treatment paradigm which:
- costs a fraction of what it takes to develop traditional molecular drugs;
- does not face the same safety and toxicity issues of traditional drugs;
- is significantly faster to develop and bring through clinical trials;
- has the agility to be updated, tailored and improved through a software update; and
- may enable efficient tracking of adherence (where cleared by the FDA).
From an investment perspective, we are excited by the ability to blend therapeutic type revenues with software development and maintenance costs, and we believe that we are on the cusp of this significant new market opening up. We believe in both the standalone potential of PDTs, as well as their ability to be accretive to advances in digital biomarkers and the development of next-generation therapeutics – areas where Luminous has already made investments.
A final thought – here’s a graphic (courtesy of the Mahana team and updated recently by us) which shows the history of category defining life science companies spearheading new technological shifts in the industry. In our view, Mahana and its peers have the potential to write their own place into history as the PDT phenomenon takes hold – this excites us immensely.