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news.Auven Therapeutics and Bellus Health have announced that Auven has entered into a license agreement with the Icahn School of Medicine at Mount Sinai in New York, under which the company obtains rights to develop Kiacta (eprodisate) as a treatment for chronic sarcoidosis.
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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 (that is pathophysiology) in sarcoidosis patients.
Auven expects to finalize a study protocol by mid-year and anticipates that the trial will start dosing patients in the fourth quarter of 2014. The Phase II trial is expected to be completed within approximately 18 months of the time the first patient is enrolled.
The idea to use Kiacta as a treatment for chronic sarcoidosis was developed by Dr Adam S Morgenthau, assistant professor of Medicine at the Icahn School of Medicine at Mount Sinai.
Auven Therapeutics co-founder and managing general partner Dr Peter B Corr noted that there is no cure for sarcoidosis, and treatment options are limited and can have serious adverse effects.
"Obtaining the rights to move KIACTA™ into a second indication further expands its commercial potential and may help patients with this sometimes debilitating chronic disease" Dr Corr added.
Kiacta is an orally bioavailable small molecule, currently being investigated in a Phase III pivotal study in patients with AA Amyloidosis, an orphan indication that results from long-standing inflammatory conditions.
Auven Therapeutics acquired worldwide rights related to Kiacta from Bellus Health in 2010 and assumed control of the Kiacta development program and related activities, including the Phase III clinical study in AA Amyloidosis.
The agreement was negotiated through Mount Sinai Innovation Partners which facilitates the real-world application and commercialization of Mount Sinai discoveries and the development of research partnerships with industry.