Liposome-based Biomimetic Treatment for auto-immune diabetes (T1D)

Project Information

LIPOBITS

Grant agreement ID: 837515

DOI

10.3030/837515

Project closed

EC signature date 23 November 2018

Start date 1 December 2018

End date 31 May 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

AHEAD THERAPEUTICS SL
Spain

Periodic Reporting for period 1 - LIPOBITS (Liposome-based Biomimetic Treatment for auto-immune diabetes (T1D))

Reporting period: 2018-12-01 to 2019-05-31

Summary of the context and overall objectives of the project

Autoimmune diseases (AD) affect 5-10% of the global population and require chronic palliative treatments, resulting in lower quality of life and great costs for society.
Over the last decades a steady rise in the incidence and prevalence of some autoimmune diseases such as Type 1 diabetes (T1D) has been detected worldwide. T1D is caused by the autoimmune destruction of insulin-producing β-cells. Currently, the main treatments for T1D are based on replacing the insulin that is no longer produced by the pancreatic β-cells, using exogenous insulin. While other traditional solutions such as pancreatic islets transplantations and immunomodulatory treatments have major drawbacks, new approaches for ADs treatment are showing promising results. This is the case for treatments seeking the arrest of the autoimmune reaction to β-cells through antigen specific immunological tolerance induction.
Ahead Therapeutics is a start-up company exploiting a proprietary encapsulation technology to develop treatments for different AD. It has developed an innovative solution for T1D based on the use of liposomes containing auto-autoantigens. Through a biomimetic process, these liposomes can induce antigen specific immune tolerance, stopping the autoimmune reaction and allowing insulin-producing β-cells to recover, leading to a permanent cure of the disease.
The main long-term objective is to put into market a new medicinal product which cure T1D, thus enhancing patient’s life as they will not require chronic treatment. To do so, Ahead will have to complete the regulatory pre-clinical package and later on, perform Phase Ib/IIa clinical trials

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

LIPOBITS platform has already been validated in animal models and preclinical non-regulatory assays have been completed. As a result, in one hand, it has been settled the product manufacturing protocol and the route and regime of administration; and in the other hand, a deeper knowledge of the technology’s mechanism of action has been obtained.
A feasibility study has been completed defining a Regulatory Roadmap, an IPR & CMC strategy, gaining knowledge on market & competitors, enlarging key partners network, and discovering new potential licensees.
In order to disseminate our project Ahead Therapeutics attended several summits during the last year: 2nd Antigen-specific immune tolerance summit and the Treg Summit in Boston, the ”Investment Readiness Series in The City’ (UK) to meet investors from London, Cambridge & Oxford, Swiss Biotech Day, as a member of the Spanish delegation of Biotech companies and finally Ahead Therapeutics participated in the Boston Immersion Program organised by the Richi Foundation and was selected to be part of the Formation & Acceleration Program for Social Innovation Projects granted by Richi Entrepreneurs.

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)

There are more companies standing in the field than Ahead Therapeutics and, in some cases, they are at a higher developmental stage. Nevertheless, Ahead Therapeutics’ technology platform has some advantages comparing to them: the technology acts through the mimicking of a physiological process, no potential side effects are expected and easy and cost-effective synthesis.
During the project development, the expected results are: GMP like final dosage form batch production; finish preclinical regulatory toxicology assays; obtain IMPD/IND/IB dossiers approval; and successfully complete Phase Ib/IIa clinical trials.
Total diabetes care expenditure will be $802 billion by 2040, comprised of the wellness (11.2%), diagnosis (3.3%), monitoring (13.4%), and therapy (72.2%) segments. The last one, therapy market is where the solution is addressed. It is a rising market due to a rising prevalence of diabetes and its chronic nature, along with rising awareness, as well as increasing demand for innovation. In the world there are expected more than 2 Million of diabetics with diabetes type I by 2026 while in Europe, there are expected more than 1 M by 2026.
LIPOBITS is a solid high-potential innovation project expected to support Ahead’s global dimension and to generate several high qualified jobs and total incomes of 10,5 M€ by 2023, and > 300 M € considering the whole life cycle of the asset.

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