Pharmaceutical Business review

Santen files IND application with FDA for DE-122 to treat wet AMD

DE-122 is the ophthalmic formulation of Santen’s partner Tracon Pharmaceuticals’ anti-endoglin antibody, TRC105.

In March last year, Santen licensed the global rights for the development of TRC105 in ophthalmology from Tracon. As part of that deal, the IND filing for DE-122 triggers a $3m milestone payment to Tracon.

Tracon president and CEO Charles Theuer said: "The IND filing for wet AMD is an important milestone for Tracon as it both diversifies our clinical pipeline beyond oncology, and provides meaningful non-dilutive capital.

"Our experience combining TRC105 with inhibitors of the VEGF pathway in cancer patients suggests that the development of DE-122 in wet AMD, where VEGF inhibitors are the established standard of care, has the potential to offer patients who receive little or no benefit from current therapy an important new treatment option.

"We look forward to continuing to work closely with Santen as the company initiates clinical studies of DE-122 in wet AMD."

TRC105 is a new, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation.

Currently, TRC105 is being evaluated in multiple Phase II trials sponsored by both Tracon and the National Cancer Institute to treat multiple solid tumor types in combination with VEGF inhibitors.