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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - Capsulight (The first ingestible capsule for eradicating Helicobacter pylori infection through photodynamic therapy)

Teaser

Summary

Helicobacter pylori is a bacterium of the stomach which affects on average 50% of the world population, reaching up to 70% in some EU Countries. Once diagnosed, it has to be eradicated, since it is a carcinogen agent and around 90% of all gastric cancers can be attributable to its infection.
The only available treatment is a pharmacological therapy based on proton-pump inhibitor and a mix of 3 antibiotic drugs. The treatment for the bacterium eradication has severe side-effects due to the assumptions of several antibiotics for 14 days and has been proven to have negative impact on the gut microbiota. Due to increasing antibiotic resistance rates to the main antibiotics used for treatment, up to 20% of the affected population cannot be cured, despite several cycles of antibiotic therapy and usually endoscopic biopsy. Besides the social impact of such refractory cases, National Health Systems and patients have also to bear several costs linked to the repeated cycles of therapies, clinic visits and exams.
Probiomedica is a spin-off of the University of Florence and Scuola Superiore Santâ€™Anna, which has developed and patented CapsuLight, the first ingestible capsule able to eradicate H. pylori infection through intragastric photodynamic therapy, that is through the power of light. The device is based on the established technology and safety of endoscopic capsules, and our preliminary in vitro tests showed 97% efficacy in killing the bacterium. The advantages for infected population are unparalleled: the possibility to eradicate the bacterium for those who cannot be cured due to antibiotic resistance; the higher efficacy rate, no side effects due to antibiotic cycles, and easy posology for all the infected population (secondary market). CapsuLight will also provide high economic savings to National Healthcare Systems, by reducing drug therapies cycles and endoscopic biopsies and related costs. The objectives of the Phase 1 SME project were to define the final design of the capsule, set up a work plan for reaching the CE mark and certifications needed, study the market size and define the business model for producing, distributing and marketing the product. Probiomedica has presented the product to several gastroenterology centers and will optimize the capsule design for further miniaturization and mass production, undergoing the necessary clinical validation for getting the CE mark.

Work performed

During Phase 1 we performed tech activities and business analysis. On the tech side, the main goal has been the capsule re-design, which encompassed mainly: a new and more sensible pH-sensor has been designed to drive the device switching on and off according to the environmental pH; increased inner volume percentage dedicated to battery volume through a smarter design of the space occupied by all components; improved emission geometry by means of smaller and more numerous and efficient LEDs; improved emission spectrum, thanks to the presence of 3-colour LEDs; improved emission control, thanks to the introduction of a temperature sensor and a light sensor; finally, improved electronics by dedicated drivers for each emitted colour.
Furthermore, laboratory tests have been performed to verify the overall functioning (magnetic or optical switching, emission time and modality), the emission features (light spectrum and emitted light power) and the resistance to the passage of the capsule through the gastro-intestinal tract.
On the business side, we interacted with CROs and notified bodies to define the plan for product certification and scouted suppliers for the supply of components and assembly. We then interacted with gastroenterology experts, clinics and patients to validate the value proposition, and analysed the available literature for estimating the overall market size (both refractory adopters and the whole H. pylori-infected population). We also run a specific business case for the first target area (Italy) to validate the benefits of the CapsuLight solution against the current treatments.
A deep study of the regulatory and reimbursement system in key target areas has been key to orientate our marketing strategy, which will be directed to commercialize the product in Italy and then move to other key EU countries thanks to partnership with distributors. Based on such data, we also defined eco-fin projections stemming out from the expected revenues, and also set up the whole plan for engineering, certifying and commercializing the product.

Final results

By interacting with clinicians and experts in H. pylori, we had the opportunity to consolidate the added values offered by our solution with respect to state-of-the-art, which are poised to have a significant social and economic impact on both the patients and the National Healthcare Systems:
â€¢ The only antibiotic-resistance-free treatment of H. pylori. Being free from antibiotic resistance, CapsuLight is the only available treatment for refractory patients (about 20% of the treated population), who currently have no alternative solution. Literature data report up to 40-50% resistance to certain antibiotic categories. CapsuLight would provide clinical practice with a completely new approach for replacing antibiotic treatments of a much diffused and potentially dangerous bacterium, thus contributing in the middle-long term to fight antibiotic resistance.
â€¢ The only treatment of H. pylori which has no side effects. 50% percent of patients have side effects while taking H. pylori pharmacologic treatment, and up to 10% are reported to make adjustments in the dose or timing of medication or even stop the treatment because of the side effects. As demonstrated by recent studies, H. pylori eradication with antibiotic treatment causes the alteration of the human gut microbiome, with an improvement in glucose homeostasis even 2 months after H. pylori eradication, thus damaging gastrointestinal integrity and function.
â€¢ An easy to administer treatment, which is poised to improve patientsâ€™ compliance. Compliance with current therapy is a crucial important factor in the eradication of H. pylori. Several studies confirmed that 10% of patients usually fail to take even 60% of medications, due to the high number of medicines which have to be taken frequently during the 14-day treatment.
â€¢ Economic savings for patients and National Healthcare Systems, thanks to abatement of the costs incurred by refractory patients well as medications for treating antibiotic side-effects. A preliminary business case run in Italy showed that NHSs and patients can save up to 10% of the current costs.
Probiomedica intends to put into practice the workplan for reaching the commercialization stage, thus fulfilling its vision to boost high-tech, non-pharmacological treatments based on the LED technology for safe, non-invasive and highly-efficient photodynamic treatment of gastric infections. Our strategy encompasses the further technical development of new CapsuLight features, as well as the market expansion in key areas like USA by getting FDA approval.
Potential next steps would be the development of new products for treating other bacterial pathologies of the intestine (bacterium-killing) and for optimizing the gut microbiota through light stimulation.