Serendex strives for creating value by minimising unknown risk parameters in our R&D.

The first steps of the R&D cycle encompass an early proof of efficacy in patients. This step has the highest priority within each of our project. With an early proof of efficacy in patients the probability for reaching the market is high, and the value of the project goes up considerably.

Subsequent filing for Orphan Drug designation and fast entering into protocol advice with both EMEA and FDA is the next step in the development. Developing drugs this way increases the likelihood of a fast track to the market with a high probability for successful development.

• Recombinant Granulocyte Macrophage Colony Stimulating Factor (rGM-CSF) for the upregulation of pulmonary host defence, e.g. in the treatment of Cystic Fibrosis (CF) and other lung diseases like ventilator acquired pneumonia (VAP).  
• Inhalation or local pulmonary deposition of recombinant Factor VIIa (rFVIIa) for hemostasis in conditions with bleeding in the lungs, e.g. for the treatment of diffuse alveolar hemorrhage (DAH). rFVIIa has already passed scientific advice according to the Orphan Drug (OD) designation procedure at both EMEA and FDA. 
• Inhalation of recombinant Activated Protein C (rAPC) is prioritized for the treatment of acute respiratory distress syndrome (ARDS).