Sparks

Isofol Medical has announced that it has been granted a pre-investigational new drug (IND) meeting with the US FDA for arfolitixorin, the company’s proprietary candidate designed to improve survival  for patients with colorectal cancer, marking an important regulatory milestone. The pre-IND meeting will provide regulatory clarity on the subsequent stages of clinical development for arfolitixorin in the US.

The drug candidate is currently being evaluated in a Phase Ib/II trial based in Germany, aiming to assess safety and tolerability at ascending doses, while also exploring efficacy. The second part of the study will include additional countries and focus on efficacy as a primary outcome measure.

While still in the early stages of development, this latest update signals Isofol’s renewed commitment to extracting value from arfolitixorin, and positive regulatory feedback from the pre-IND meeting could represent an upcoming catalyst for the company.