We have partnered with some of the world’s leading research and academic organizations. Our strategy is to discover and develop programs that target orphan diseases with larger, unmet medical potential. We are currently seeking partners to advance our existing and future programs.
SteroTherapeutics has entered into a Cooperative Research and Development Agreement (CRADA) with
the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of
the National Institutes of Health (NIH), to complete a Phase 2 clinical trial using ST-002 for Cushing's syndrome.
ST-002 and ST-003 have been granted orphan drug designation by the FDA. The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition which affects fewer than 200,000 people in the United States. Orphan drug designation qualifies sponsors for incentives including:
Tax credits for qualified clinical trials
Exemption from user fees
Potential seven years of market exclusivity after approval
Sterotherapeutics has partnered with the Department of Veterans Affairs and the University of Texas at Austin to develop ST-003 for the treatment of primary sclerosing cholangitis (PSC), a chronic autoimmune disease of the bile ducts. PSC is a pan hepatic liver disease with significant morbidity, progression to end-stage liver cancer, and mortality. Currently, liver transplantation is the only treatment for PSC.
ST-004 was licensed from the Moffitt Cancer Center to target multiple myeloma, a malignancy localized
to the bone marrow arising from clonal proliferation of plasma cells.
SteroTherapeutics is actively seeking partners for this program.