Research and Development for innovative glucocorticoids treatment for acute medical conditions

Purpose and goal

The aim of AcuCort AB´s project is to develop a drug product for administration to the oral cavity and from which a rapid uptake of a well-known glucocorticoid can be achieved. Conditions for which such product can be of great value are for example acute allergic asthma. The aim of the sub-project for which VINNOVA funding was granted was to develop this product up to a point where it could be GMP-manufactured, for subsequent testing on humans in a clinical phase I study. This aim has been fully accomplished.

Results and expected effects

The effect of having accomplished the aim of the sub-project for which VINNOVA funding was granted is that a clinical phase I study will be conducted during 2013 Q2-Q3, and the anticipated result from that study is that AcuCort AB´s product concept will be verified and that a decision is then taken to continue the development with the goal that the product should reach the market.

Approach and implementation

The operational model in the sub-project for which VINNOVA funding was granted has been to outsource the development work to suppliers, so called CROs and CMOs. In this case these suppliers were located in Sweden, the US, Germany and Denmark, and AcuCort´s role - in addition to financing the activities - have been to define the objectives, coordinate the work, and follow up how well objectives have been reached. This operational model is called ´virtual´ and means specific requirements on company and personnel performing the task. Our analysis is that in this case it has worked out well.