Clinical assessment of PILA PHARMA’s TRPV1 antagonist, XEN-D0501, as a novel type of oral anti-diabetic agent

Project Information

XEND

Grant agreement ID: 856317

DOI

10.3030/856317

Project closed

EC signature date 23 January 2019

Start date 1 February 2019

End date 31 July 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

PILA PHARMA AB
Sweden

Periodic Reporting for period 1 - XEND (Clinical assessment of PILA PHARMA’s TRPV1 antagonist, XEN-D0501, as a novel type of oral anti-diabetic agent)

Reporting period: 2019-02-01 to 2019-07-31

Summary of the context and overall objectives of the project

Diabetes is a group of metabolic diseases in which the person has high blood glucose (blood sugar), either because insulin production is inadequate or one does not produce insulin (known as type 1 diabetes), or because the body's cells do not respond properly to insulin (known as type 2 diabetes), or both. TRPV1 (transient receptor potential vanilloid 1)-antagonists are substances that can temporarily block the activity of the ‘chili-receptor’, TRPV1. TRPV1 has been studied intensively in the area of pain management as a potential target to control chronic pain as a supplement to pain killers. To date, none of the TRPV1 antagonists in clinical development have been assessed for their eventual antidiabetic effects in man.
The overall objectives of this project were to develop and optimize a business plan that will guide the exploitation and commercialization of PILA PHARMA’s compound - XEN-D0501 that has enormous potential to treat type 2 diabetes.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

PILA PHARMA performed the feasibility study, which then will guide the overall company business development strategy. It provided a valuable understanding of the current trends and opportunities on the type 2 diabetes market, targeted users, competitive landscape, and potential partnership opportunities. A work plan for carrying out further studies that will evaluate the benefit of our product in type 2 diabetes patients was also developed.
The feasibility study has confirmed that there is a clear business opportunity to exploit the global antidiabetic therapeutics market.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

This feasibility study has confirmed the innovative character of the PILA PHARMA’s approach. We have confirmed that TRPV1 antagonists represent a novel therapeutic approach to treat both type 2 diabetes and its inflammation-related co-morbidities. The co-morbidities of type 2 diabetes, in particular, cardiovascular disease are a leading cause of disability and premature death. According to the European Medicines Agency 1, about half of type 2 diabetes patients need a new drug to maintain adequate glucose control every 3 to 4 years. This necessitates a constant renewal of therapeutic approaches. We are the first company to begin the clinical testing of a TRPV1 antagonist specifically as a treatment for type 2 diabetes. We thrive to validate our promising results further and the potential for a novel antidiabetic drug that will provide optimal therapy and decrease healthcare costs. The problem of diabetes is growing dramatically and PILA PHARMA is assured of the significant impact its innovative approach will have on the diabetes burden in Europe and worldwide.

PILA PHARMA