Periodic Reporting for period 1 - LIPOBITS (Liposome-based Biomimetic Treatment for auto-immune diabetes (T1D))
Período documentado: 2018-12-01 hasta 2019-05-31
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
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.
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.