TherapeutAix was approached by a US-based biotech company to review an asset that they were considering repositioning for fibrotic disease. The company asked for specific help in reviewing existing data, defining the steps then required to take the asset to IND-enabling studies and into the clinic.
The task was to review the existing data and background information and to provide an opinion on how the asset could be positioned for the treatment of fibrotic disease.
The TherapeutAix team reviewed the background literature and existing data with respect to fibrosis. Gaps in the pre-clinical data package were identified that would need to be filled to progress the asset for fibrosis. Suitable and decision-making PK/PD experiments, in vitro and ex vivo, biomarker-led studies were proposed and subsequently prosecuted by us, using our network of CROs. Additionally, potential clinical positioning options were reviewed, and proposals prepared and presented to the company’s Board for consideration.
A comprehensive review of the asset, landscape, potential positioning was prepared and provided to the Company, together with decision-making data from pre-clinical studies.