When LEO Pharma is developing a potential new treatment option it undergoes an extensive clinical trials programme in order to ensure its efficacy, safety and performance, in-line with the stringent legal and regulatory requirements for pharmaceutical products.
In line with our principles and values LEO Pharma always conduct transparent and open clinical trials of our drug candidates in the Research & Development phase, which ultimately allows us to continue to drive forward new solutions to help patients; what we call Helping SARAH.
LEO Pharma is committed to being people-focused in all we do. Our Patient and Scientific Review Board, which reviews applications for access to patient-level data in clinical trials, consists of external researchers and patient organisations to ensure that the highest ethical standards are maintained.
We made a landmark pledge in 2013, of which we are very proud as an organisation, to fully disclose our clinical trial data into the public domain back to 1990, recognising the importance of making clinical trial data available to all. LEO Pharma was the second company globally to make this pioneering declaration. This step was taken so that we can enable patients and healthcare professions to make informed decisions about their treatment and share data that contributes to the advancement of scientific understanding in our focus areas. In addition, transparency about our clinical trial data means that we can continue to lead on further research.
Stages of drug development:
Development sees the drug candidate enter clinical testing in humans. This usually takes five to seven years to complete and has several phases:
The safety and tolerability of the drug is assessed. The drug is tested in healthy human volunteers, starting at a very low dose which is eventually increased to a dose expected to be effective in patients.
The dosing and safety of the drug are investigated. The drug is tested in a small number of patients and the effect on the target disease is evaluated.
Drug efficacy and safety are investigated in statistically robust, studies which usually include several hundred patients in several countries.
Following a successful outcome of phase III studies, the drug may obtain a Marketing Authorisation (MA).
In all phases, we investigate the effects of the drug and how it interacts with normal physiological processes. We build knowledge on how the drug is absorbed, distributed, metabolised and excreted by the body. This is valuable data for documenting the effectiveness (clinical efficacy) and safety.