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news.Ambrilia Biopharma has reported positive preliminary, open-label, multicenter, randomized, non-inferiority Phase III results for its proprietary prolonged-release formulation of octreotide, or C2L, in acromegaly patients.
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The primary objective of this study comparing C2L to Sandostatin LAR was met with both C2L and Sandostatin LAR inducing a highly statistically significant decrease of insulin-like growth factor 1 (IGF-1) (p less than 0.005 for both arms) and growth hormone (GH) (p less than 0.0001 for both arms) plasma levels. It was not possible to demonstrate non-inferiority, nor inferiority, of C2L over Sandostatin LAR.
C2L and Sandostatin both induced a statistically significant decrease of IGF-1 and GH plasma levels, at all time points throughout the study and at day 84. The mean percentage of GH decrease was similar in both groups throughout the study. IGF-1 response was also similar, though more pronounced in the Sandostatin group on day 84.