Auven Therapeutics, a global private equity company focused on accelerated development of breakthrough therapeutic drugs, has entered into a license agreement with the Icahn School of Medicine at Mount Sinai in New York, under which Auven obtains rights to develop KIACTA (eprodisate) as a treatment for chronic sarcoidosis.
Auven intends to conduct a phase II (proof-of-concept) clinical trial to evaluate KIACTA’s effectiveness and safety to treat certain medical manifestations of sarcoidosis. KIACTA is aimed at addressing the disease process (i.e. pathophysiology) in sarcoidosis patients. Auven expects to finalize a study protocol by mid-year and anticipates the trial will begin dosing patients in the fourth quarter of 2014. The phase II trial is expected to be completed within approximately 18 months after the first patient is enrolled.
The idea to use KIACTA as a treatment for chronic sarcoidosis was developed by Adam S. Morgenthau, M.D., assistant professor of Medicine at the Icahn School of Medicine at Mount Sinai. Morgenthau is the director of the Sarcoidosis Clinic at Mount Sinai, which specializes in treating patients with complex cases.
Sarcoidosis is a rare condition that causes small patches of red and swollen tissue—called granulomas—that can develop in multiple organs in the body, but mostly in the lungs and skin. The disease affects approximately 20,000 patients in the U.S. alone and identification of an effective treatment is a major unmet medical need. While acute sarcoidosis can improve on its own, chronic sarcoidosis can cause scarring to the lungs and decreased lung function over time, potentially affecting other areas of the body, including the liver.
“There is no cure for sarcoidosis, and treatment options are limited and can have serious adverse effects,” said Peter B. Corr, co-founder and managing general partner of Auven Therapeutics.