Phase III trial of Octreolin meets end point in acromegaly-Chiasma

Results from a multicenter Phase III study of Octreolin (octreotide oral capsules), from Chiasma, in the treatment of adults with acromegaly were published online for early release on Feb. 9, ahead of print, by the Journal of Clinical Endocrinology & Metabolism (JCEM). Sixty-five percent of patients who received octreotide capsules twice-a-day achieved disease control, as measured by circulating concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations, at 7 months (core treatment period), meeting the primary endpoint and 62% achieved disease control at 13 months (end of treatment).

The severity and incidence of acromegaly symptoms improved, while on octreotide capsules, compared to baseline. The safety profile of octreotide capsules appears to be consistent with the known profile of injectable octreotide formulations, excluding injection site reactions. Based on these results, Chiasma intends to submit a New Drug Application to the FDA in 2015.

See: "Safety and Efficacy of Oral Octreotide in Acromegaly: Results of a Multicenter Phase III Trial." Shlomo Melmed et al. JCEM Early Release, jc.2014-4113 February 9, 2015 http://dx.doi.org/10.1210/jc.2014-4113

Comment: Current treatment options include surgery to remove the tumor, radiation therapy which destroys any lingering tumor cells and/or medical treatment in cases where these approaches are not possible or fully effective. Medical treatments available currently include dopamine agonists, GH antagonists and injectable somatostatin analogs, the current standard of care. Currently available somatostatin analogs require large-bore needles, for injections into muscle (octreotide) or deep into the tissue underlying the skin (lanreotide).