Strongbridge Biopharma Announces Issuance of US Patent for Investigational COR-003 in Treatment of Endogenous Cushing's Syndrome
Strongbridge Biopharma plc recently announced that the United States Patent and Trademark Office (USPTO) issued a patent related to the Company’s lead investigational drug candidate, COR-003 (levoketoconazole), a cortisol inhibitor that is currently being studied in a global Phase III trial for the treatment of endogenous Cushing’s syndrome.
The claims of U.S. Patent No. 9,198,906 are directed towards methods of reducing C-reactive protein (CRP) levels and systemic inflammation through administration of a once-daily dose of levoketoconazole.
“This patent is an important step forward in our research efforts in Cushing’s syndrome and for our lead investigational drug candidate, COR-003,” said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. “Our Phase 3 trial is designed to evaluate the overall safety and efficacy of COR-003 in patients with elevated levels of cortisol due to endogenous Cushing’s syndrome. We look forward to evaluating the key secondary endpoint data related to the potential benefits of reducing CRP levels and systemic inflammation in this patient population,” Pauls added.
About Strongbridge Biopharma
Strongbridge Biopharma’s strategic focus is to build a biopharmaceutical company focused on the development, in-licensing, acquisition and eventual commercialization of complementary product candidates across multiple franchises that target rare diseases.
Strongbridge Biopharma’s lead product candidate, COR-003 (levoketoconazole), is a cortisol inhibitor that is currently being studied in the global Phase 3 trial for the treatment of endogenous Cushing’s syndrome. Strongbridge Biopharma recently expanded its rare endocrine disease franchise with the completion of transactions for two Phase 2 product candidates: COR-004, a novel second-generation antisense compound, which is in clinical development for the treatment of acromegaly and designed to block the synthesis of growth hormone receptor (GHr), thereby reducing levels of insulin-like growth factor-1
(IGF-1) in the blood; and COR-005, a next-generation somatostatin analog (SSA) with a unique receptor affinity profile, being investigated for the treatment of acromegaly, with potential additional applications in Cushing’s disease and neuroendocrine tumors. COR-003 and COR-005 have received orphan designation from both the European Medicines Agency and the U.S. Food and Drug Administration, and the Company is pursuing orphan designation for COR-004. Strongbridge Biopharma’s intent is to independently commercialize its rare endocrine assets in key global markets.
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