Strongbridge Biopharma plc Announces Data Presentation at the Society for Endocrinology BES 2015 Conference
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)|
|Location:||Lennox Suite Exhibition Hall|
Earlier this year,
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