The Challenge:
TherapeutAix was approached by a small virtual biotech to review a target and asset that for a rare fibrotic disease. The company asked for specific help in reviewing the target, existing data, defining the steps then required to take the asset to IND and into the clinic.
The task was to review the existing data and background information and to provide an opinion on the validity of the target and how the asset could be positioned for the treatment of fibrotic disease.
The Action:
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 fibrotic disease. Suitable and decision-making PK/PD experiments, in vitro and ex vivo, biomarker-led studies were proposed and subsequently prosecuted in collaboration, using our network of CROs. Additionally, potential clinical positioning options were reviewed, and proposals prepared and presented to the company’s management for consideration.
The Result:
A comprehensive review of the asset, landscape, potential positioning was prepared and provided to the Company, together with plans to generate decision-making data from pre-clinical studies. This was well-received and significantly increased the level of interest from potential (big pharma) investors.