Periodic Reporting for period 1 - DiogenX (Beta-cell recovery to counter diabetes)
Reporting period: 2023-10-01 to 2024-09-30
Globally 20 M of T1D patients rely on exogenous insulin administration as the only treatment to manage their disease. The treatment is complex to follow since it requires not only to inject insulin (2-4 times/day) but to adhere to a restrictive lifestyle (e.g. following a strict diet) reducing patient QoL. An additional problem is that insulin can drive to poor glucose control which is associated with many complications (e.g. stroke, renal disease) reducing life expectancy 10-15 years.
DiogenX aims to withdraw insulin dependency and cure T1D by protecting and regeneration of pancreatic beta-cell able to produce insulin according to glycemia levels.
DiogenX aims to withdraw insulin dependency and cure T1D by protecting and regeneration of pancreatic beta-cell able to produce insulin according to glycemia levels.
The first year of the project was focused on the comparison of several Rspo1 analog drug candidates in different preclinical efficacy models to select our Lead for further development. We established that 3 analogs were able to induce in vitro the proliferation of pancreatic beta-cells (Min6 cell line), but also to control glycemia and reduce diabetes incidence in a mouse model of type 1 diabetes (NOD mice) widely used in research laboratories and by the pharma industry. To consolidate these nonclinical efficacy data, the 3 analogues were also tested and found active on primary human pancreatic islets.
With the selected Lead analog candidate, we performed studies to evaluate its pharmacokinetics and nonclinical safety profiles, and it was found well tolerated, with no adverse findings precluding further development.
The development of the process to manufacture the Lead candidate was also initiated, with the identification of the most appropriate culture system, the development of the producing cell line and initial scale-up of production volumes.
With the selected Lead analog candidate, we performed studies to evaluate its pharmacokinetics and nonclinical safety profiles, and it was found well tolerated, with no adverse findings precluding further development.
The development of the process to manufacture the Lead candidate was also initiated, with the identification of the most appropriate culture system, the development of the producing cell line and initial scale-up of production volumes.
The results obtained over the past year confirm the relevance of DiogenX scientific approach, that aims to target the Wnt pathway in the pancreas with Rspo1 analogs to regenerate beta-cells and control diabetes. The extent of our nonclinical results, in terms of efficacy and safety, fully support moving the Lead candidate further in development, to potentially become a first-in-class disease modifying therapy for people living with type 1 diabetes, so that they become independent from exogenous insulin.