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Product development

The development of a sublingual insulin formulation

Developing orally available insulin is a daunting task and as such it is regarded as the holy grail in insulin delivery. Although being one of the smallest endogenous proteins, insulin is still too large and polar to simply pass the buccal mucosal layers to reach the blood stream. Downstream intestinal absorption is also impossible for natural insulin, since it is readily degraded in the digestive tract, rendering it non-functional. Two options exist to address these problems, being either insulin protection against the acidic and enzymatic degradation processes in the digestive tract, or encapsulating insulin to trigger oral absorption thus avoiding the harsh digestive tract. Our SLIM solution focusses on encapsulated insulin for oral absorption, due to the existence of our nanotechnology-based formulation and already available drugs like insulin. By focusing solely on a drug-delivery technology, we enabled short development times and lower costs, whilst having an excellent safety profile thanks to the safe-by-design approach using exclusively FDA-approved compounds.

Sublin BV is a late-pre-clinical stage company, moving forward towards the clinical testing of a sublingual insulin formulation within months. Validating experiments in in vitro studies lead the researchers of Sublin to a promising compound. This compound did not only lower blood glucose levels in relevant diabetes models upon sublingual application, but also showed a clear dose-response relationship. The efficacy of our compound when applied via the mouth indicated an extremely promising bioavailability. We are preparing our short-acting (prandial) and long-acting (maintenance) insulin release formulations to ensure an optimally effective, stable and fully safe product that can be brought into clinical studies.

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