Mechanism based drug profiling in volunteers and patients

The particular strength of C4Pain is the “one partner translational concept”. Interpretation of pre-clinical data and results from targeted early proof-of-concept experimental pain bio-marker studies (in volunteers or selected patients) are transferred into tailored small mechanisms based clinical trials validating the target followed by larger clinical trials on well characterized pain patient (sub-) populations.

Experimental human pain-biomarkers

The challenge is to translate the animal experimental data on analgesic efficacy into a meaningful clinical context. It is well known that maximally 10% of the pre-clinical findings on drug effects translate to humans. C4Pain therefore follows the strategy to move into humans as early in the development process as possible using translational human pain bio-markers for drug profiling.

A human pain bio-marker is defined as a technique to induce a pain mechanism in a standardised way and asses the response in a quantitative way. The human pain bio-markers approach is used in mechanisms based drug profiling.

Early phase trials applying bio-markers can be performed in healthy volunteers (phase I mechanism based proof-of-concept experimental studies) or in small clinical studies (phase I mechanism based proof-of-concept experimental clinical studies, phase II mechanism based proof-of-concept clinical studies)

Later phase larger clinical trials (phase III and IV pain trials) on e.g. acute pain, inflammatory pain, neuropathic pain, musculoskeletal pain, visceral pain, headaches, dysfunctional pain syndromes includes as well standard clinical measures as the most sensitive pain bio-markers.