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Strongbridge Biopharma plc Announces Data Presentation at the Society for Endocrinology BES 2015 Conference

Secondary Analysis from Phase 2 Study Supports Novel Mechanism of Action of COR-004 to Reduce IGF-1 in Patients with Acromegaly by Inhibiting Growth Hormone Receptor (GHR) Expression

November 3, 2015 – Dublin, Ireland and Trevose, Pa., – Strongbridge Biopharma plc (NASDAQ: SBBP) today announced that results from a secondary efficacy analysis of the completed Phase 2 trial for COR-004 in adult patients with acromegaly will be presented at the Society for Endocrinology BES 2015 conference being held in Edinburgh, UK from November 2-4, 2015.

The Phase 2 clinical trial was a randomized, open-label, parallel group clinical trial of the safety, tolerability, pharmacokinetics and efficacy of two subcutaneous administration regimens of COR-004 in 26 adult patients with acromegaly treated over 13 weeks. The trial met its key efficacy endpoint demonstrating a statistically significant average reduction in the serum insulin-like growth factor 1 (IGF-1) levels from baseline in the higher dose group. COR-004 was safe and well tolerated. The main adverse event was mild to moderate injection site reactions in the majority of patients.

As one of the secondary endpoints, the level of growth hormone (GH)-binding protein (GHBP) as a marker of growth hormone receptor (GHR) expression was evaluated. With the larger dose, a continuous decrease in GHBP was found that reached statistical significance at the end of the study, coinciding with a significant reduction in IGF-1. These data provide further evidence for the efficacy of COR-004 and its ability to inhibit growth hormone receptor (GHR) expression. Data from future clinical trials will help to evaluate the relationship between COR-004 dose, GH levels, GHBP levels and the change in IGF-1 with treatment.

The poster presentation information is listed below:

Presentation Title: In patients with acromegaly antisense oligomer therapy directed at the GH receptor is associated with reduction in circulating GHBP levels
Date: Tuesday, November 3, 2015
Time: 1:00 p.m. to 2:15 p.m. (GMT)
Session Title: Pituitary
Location: Lennox Suite Exhibition Hall
Abstract Number: P308

Earlier this year, Strongbridge Biopharma plc entered into an exclusive licensing agreement for commercialization rights to Antisense Therapeutics’ ATL1103, now known as COR-004, for endocrinology applications.

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. COR-003 has received orphan designation from both the European Medicines Agency and the U.S. Food and Drug Administration. 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 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. Strongbridge Biopharma’s intent is to independently commercialize its rare endocrine assets in key global markets.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements. These statements relate to future events and involve known and unknown risks, including, without limitation, uncertainties regarding Strongbridge’s strategy, outcomes of product development efforts and objectives of management for future operations. The words “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.


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Source: Strongbridge Biopharma