Insmed Reports Positive Results From SomatoKine Trial

Insmed has announced updated results for the company's pivotal Phase III clinical trial evaluating SomatoKine (mecasermin rinfabate), a once daily insulin-like growth factor I (IGF-I) replacement therapy delivered as a proprietary complex of rhIGF-I/rhIGFBP-3, in children with short stature due to growth hormone (GH) insensitivity syndrome (GHIS).

The primary endpoint of change in height velocity after six months on treatment was achieved and was highly statistically significant.

This prospective clinical study was designed to gain FDA approval for the treatment of GHIS with SomatoKine. At the initiation of the study, all patients were prepubertal and identified as having GHIS (including subjects with GH receptor deficiency and GH gene deletion). Patient ages were between 3 and 15 years, with an average age of 8 years. The starting heights ranged from 27 to 50 inches (average 35 inches).

The children received once-daily injections of SomatoKine in the evening at doses of 0.5 - 2 mg/kg. Individual dose adjustments were made to restore and maintain serum IGF-I levels in the normal range.