Periodic Reporting for period 1 - HormoCaps (Gut HORMOne stimulating CAPSules for the treatment of gastrointestinal metabolic disorders)
Periodo di rendicontazione: 2024-07-01 al 2025-12-31
There is increasing interest in developing oral alternatives for the delivery of incretin-based therapies. As the GLP-1 market continues to expand and evolve, the impact that incretin-based treatments have had—and continue to have—on the management of chronic diseases such as diabetes and obesity represents a major therapeutic advance with the potential to improve the lives of countless patients worldwide. The Hormocaps project aimed to generate supporting evidence for the pharmaceutical potential and commercial value of gut hormone–stimulating lipid nanocapsules for the treatment of gastrointestinal metabolic disorders. The project explored the technical feasibility of the formulation, including its stability and dosing, as well as its preclinical validation in pigs. To this end, we lyophilized the formulation for delivery in enteric capsules and conducted a preclinical evaluation in a porcine model. Finally, we performed a market analysis to assess market opportunities and the potential for licensing our patent.
The main objective of the Hormocaps project was to demonstrate the feasibility of delivering our formulation in capsule form at an effective dose. This objective was addressed at three levels: technical, preclinical, and commercial. The technical work focused on three key aspects: (a) evaluating the feasibility of the required dose and volume, as well as capsule filling; (b) assessing the chemical stability of the nanocapsules during storage, both before and after capsule filling; and (c) establishing an effective dose of the formulation to stimulate gut hormone secretion in large animals. The preclinical evaluation involved the assessment of gut hormone stimulation in pigs. Finally, a market analysis was conducted to identify trends and competition in the field of metabolic disorders, with the aim of identifying potential companies interested in our technology
In the Hormocaps project, we have assessed the technical and commercial feasibility and opportunities of our nanocapsule-based formulation. With the support of a consulting company, we conducted a market analysis to help position our product within the incretin-based therapeutics market and to identify potential applications and partners for technology licensing. Importantly, our formulation is not limited to the encapsulation of a single peptide, and it allows modulation toward different hormone secretion profiles. This versatility opens opportunities to explore the potential of our formulation beyond single-peptide encapsulation.