30.07.2015 08:28:17

Towering Or Stunted? Ascendis Pharma Will Reveal It Today...

(RTTNews) - Ascendis Pharma A/S (ASND) is scheduled to report top-line results from a phase II pediatric study of TransCon hGH before the market opens today.

TransCon hGH is a once-weekly prodrug that releases unmodified growth hormone. The current standard of care for the treatment of Growth hormone deficiency, requires patients to receive daily injections of hGH over many years. But treatment with TransCon Growth Hormone is required to be administered only once weekly as a subcutaneous injection.

Growth hormone deficiency, or GHD, is a disorder in which the pituitary gland does not produce enough growth hormone, called Somatropin. This serious orphan disease affects both children and adults.

Children with GHD are characterized by short stature, metabolic abnormalities, cognitive deficiencies and poor quality of life. GHD in adults is associated with premature mortality, increased adiposity, or fat mass, as well as psychiatric-cognitive, cardiovascular, muscular, metabolic and skeletal abnormalities.

A phase II study of TransCon hGH in adults with GHD was successfully completed in 2011, with the study achieving the primary efficacy endpoint of the change in IGF-I levels from baseline compared to daily growth hormone.

The phase II pediatric clinical study of TransCon hGH, whose top line results are scheduled to be reported today, was initiated in September 2013, and enrolled 53 pre-pubertal children with GHD.

Last December, the company reported positive results from a six-month interim analysis of 25 pediatric patients enrolled in the study - where significant mean annualized height velocity was achieved with TransCon Growth Hormone.

Will TransCon hGH be able to put up an encore performance? Stay tuned…

ASND closed Wednesday's trading at $19.93, down 1.68%. In after-hours, the stock was 0.30% to $19.99.

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