A novel drug candidate for the treatment of Eosinophilic Esophagitis - an innovative solution for a significant unmet medical need

Project Information

theEoE

Grant agreement ID: 745175

DOI

10.3030/745175

Project closed

EC signature date 26 November 2016

Start date 1 December 2016

End date 30 April 2017

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

THELIAL TECHNOLOGIES SA
Portugal

Periodic Reporting for period 1 - theEoE (A novel drug candidate for the treatment of Eosinophilic Esophagitis - an innovative solution for a significant unmet medical need)

Reporting period: 2016-12-01 to 2017-04-30

Summary of the context and overall objectives of the project

EoE is a chronic inflammatory disease wherein a certain variety of white blood cell (eosinophils) build up in the esophagus. esophagealand the disease commonly results in narrowing of the esophageal passage, also known as stricture. This can cause difficulties in swallowing food or even cause outright blockages when food becomes trapped in the passage (also known as impaction).
Thelial presents The1, the first orphan drug developed through their drug discovery platform, theLiTE™ (Thelial Live Targeted Epithelia). As the first drug specifically to treat EoE, with a notable reduction in side effects, The1 is an immediate improvement on the state of the art. The1 reduces the clinical symptoms, modifies disease progression through tissue remodelling, and increases the duration of treatment response. These features will allow physicians, patients and payers to benefit from a revolutionary new treatment with fewer side effects, and lower risk of health complications thanks to better long-term management of the condition over time.
Thelial’s pre-clinical programme focuses on development of The1 as a drug, which can then be used to support the validation and viability of TheLiTE™ as a platform for further underserviced diseases.

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

Deepen the study on the requirements and standards for medical devices and define a minimum viable product for the discovery platform’s outputs: basic information e.g. drug delivery method decided. Liquid medium – syrup. Prescription information to be decided based on results of pre-clinical trials.
Plan feasible product development from current readiness level to TRL9 for The1: Pre-clinical programme devised. Clinical programme outlined. Post-clinical trial activities identified.
Outline pre-clinical programme: Pre-clinical trial activities identified, impact on future developments elaborated. Quote summary in Appendix 1.
Establish a feasible industrialisation plan (large scale production process) and elaborate the business full operations: regulations identified for EU & US market entry, value chain outlined.
Risk assessment & Contingency Plan: main risks identified and proper counteractions planned.
Scout and identify EU industrial partners (SMEs/Large Enterprises) in the supply/value chain, and all institutional / medical stakeholders influencing the success of commercialisation: all identified profiles/stakeholders contacted and pre-clinical programme stakeholders contacted.
Size the reachable customers and a reliable market share: qualitative and quantitative results shown from comprehensive analysis of customers and entry barriers.
Commercial viability check (establish a sound Go-to-market Strategy) and development of a suitable Marketing & Communication strategy: securing the interest for the project and further cooperation of a
CRO/CMO.
Accomplish 5-years financial projections.
Establish an effective IP management strategy: identify a comprehensive IP management strategy including protection methods (patent, trademark, trade secret, etc.).

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)

In contrast, Thelial presents The1, the first orphan drug developed through their drug discovery platform, theLiTE™ (Thelial Live Targeted Epithelia). As the first drug specifically to treat EoE, with a notable reduction in side effects, The1 is an immediate improvement on the state of the art. Extracted from plant matter, The1 is delivered orally, in a syrup format. The syrup dose should be followed ~30 minutes later with water to clear the mouth of any residue, without compromising effectiveness of the dose. The1 reduces the clinical symptoms, modifies disease progression through tissue remodelling, and increases the duration of treatment response. These features will allow physicians, patients and payers to benefit from a revolutionary new treatment with fewer side effects, and lower risk of health complications thanks to better long-term management of the condition over time.

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