Clinical validation
Clinical validation reduces risk in Biotica’s lead optimisation programmes and offers a clear pathway to preclinical proof of concept
There are three main sources of clinically validated projects:
- Generating analogues for the same indication as the parent but with improved properties;
- Generating analogues optimised for use in indications in which the parent has shown clinical efficacy but has not been approved;
- Optimizing polyketides with the same target as a different compound that has demonstrated clinical activity.
Clinical validation informs development
Clinical validation reduces the technical risk in a development programme, since the effects of addressing that target are already known. During the exploratory phase of a project, clinical validation enables Biotica to design a clear target product profile for the programme. This includes building in proof-of-concept studies early into the screening cascade and preclinical development programme, based on the optimisation criteria compared to the lead polyketide.
