The drug candidate has now advanced to the clinical testing in humans, which traditionally takes five to seven years.
In phase I, we test the drug in healthy volunteers starting with very small doses followed by higher until the doses are expected to be effective in patients. The safety and tolerability of the drug is assessed, and pharmacokinetic evaluations are performed.
In phase II, the drug is tested in few patients and the effect on the target disease is evaluated. In addition, the dosing of the drug and the safety in patients are investigated.
In phase III, the findings from phase II are confirmed in a large patient population. The purpose is to demonstrate efficacy and safety in statistically robust, unbiased studies, which usually include several hundred patients from many hospitals in several countries, and the trials are traditionally controlled and double-blind. We co-operate with more than 1,000 investigators worldwide to conduct the trials.
After successful phase III studies, the drug may obtain marketing authorisation, and is usually further investigated in several phase IV trials to define the exact role of the drug in treatment of diseases.
In all phases, we investigate and document the toxicity of the drug and how administration of the drug interacts with physiological processes, including building knowledge on how the drug is absorbed, distributed, metabolised and excreted. This is paramount knowledge for documenting the clinical efficacy and safety of the new drug.