From basic to clinical pharmacology
In 1995 the Center for Clinical Pharmacology was founded by Prof. Dr. Paul De Schepper. It was set up as a self-supporting Academic Research Organisation located on Campus Gasthuisberg and independent from the Department of Pharmacology of the KU Leuven. In 2002 the research unit moved into a new purpose built ward in the University Hospitals of Leuven.
Since its foundation, over 200 trials have been conducted: “microdosing” (phase 0) and complex imaging trials, challenging First-in-Man trials (phase 1) and more demanding phase 2 trials in special patient populations.
Given this track record of over 20 years of clinical research experience, it is fair to say that our research unit has gained its excellent reputation based on proven output and performance.
In the earlier days the academic research focused on in vivo cardiovascular pharmacology by applying invasive and non-invasive state-of-the-art techniques to healthy volunteers and selected groups of patients. Amongst others, high-resolution ultrasound equipment, venous occlusion plethysmography and pulse wave analyses were used to evaluate the cardiovascular effects of medicines. In combination, these techniques allowed us to investigate distinct vascular territories simultaneously and to determine the influence of vasoactive compounds after systemic or local administration.
As these techniques go beyond the routine recording of blood pressure, heart rate and 12-lead electrocardiography (ECG), they offer a much more in depth assessment of the cardiovascular function in vivo in humans. Consequently, compounds developed with the intent to affect the cardiovascular system (efficacy assessment) as well as compounds which are supposed to be devoid of cardiovascular effects (safety assessment) were investigated in healthy volunteers and selected groups of patients.
From migraine to pain…
Over the years a special expertise has been acquired in the area of pain in general and migraine in particular.
Regarding migraine, many acute and chronic antimigraine drugs, small molecules as well as biologicals, were tested at our clinic and developed up to Proof-of-Principle (PoP). In the context of these trials and in order to support the go/no-go decision for these compounds, a target engagement biomarker was developed for drugs interfering with calcitonin gene-related peptide (CGRP). This resulted in a model referred to as the “capsaicin model” which has become an established tool for evaluating drugs targeting the CGRP pathway. Based on data obtained with target engagement biomarkers, dose selections were guided in the interest of proceeding more confidently into early efficacy trials. Taken together, target engagement biomarkers have proven to be an invaluable asset fueling a data driven and more efficient rational drug development process.
Next to migraine, which is a very specific kind of pain disorder, we recently broadened our scope to pain in general and became involved in challenging scientific projects with alternative strategies for the development of new analgesics.
For a better impression about our experience and projects in the area of migraine you are kindly referred to our publication list.