Challenge:
Our client specialized in the development of proprietary monoclonal antibodies directed towards novel targets for the treatment of immune-mediated and fibrotic disorders, including orphan indications. It had identified a novel pathway that mediated inflammation and fibrosis, and as such had developed proprietary antibodies to target it. For the lead antibody the client planned to initiate a Phase IIa proof of concept (POC) repeat dose safety study in patients with a fibrotic liver indication and asked Alacrita to help create the IMPD and manage the submission of the Clinical Trial Application and associated approvals.
Solution:
Our Regulatory consultants worked together with the client team to create, proof read and collate all documents required for the submissions and were the point of contact for all authorities responses and queries. Approval of the trial was received quickly and Alacrita remains engaged with the client for ongoing regulatory support.