Chiasma Inc., a U.S. privately-held biopharma company, announced today that results from a multicenter Phase III study of the investigational new drug, octreotide capsules, were published online for early release on Feb. 9, ahead of print, by the Journal of Clinical Endocrinology & Metabolism (JCEM).
The investigational drug, octreotide capsules, is an oral form of the peptide octreotide, a somatostatin analog, for potential use in the treatment of adults with acromegaly, a rare endocrine disease. Patients were evaluated for biochemical and symptomatic disease control over a 13-month period following treatment with octreotide capsules. 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.
"Acromegaly is a challenging disease, mostly requiring chronic injections of somatostatin analogs into the muscle or deep sub-dermal tissues by healthcare professionals, to maintain disease control. Currently available medications force most patients to plan their lives around the injections with regular visits to clinics just to receive treatment," said Shlomo Melmed, M.D., senior vice president and dean, Cedars-Sinai Medical Center, Los Angeles and global study principal investigator. "These new results using a daily oral drug are an important advance for people with acromegaly."
"The safety profile of octreotide capsules appears to be consistent with the known profile of injectable octreotide formulations, excluding injection site reactions," stated Gary Patou, M.D., Chiasma's senior medical advisor. "In fact, in this study, we saw the incidence of adverse events significantly decrease over time."
"Chiasma is pleased with the results of this Phase III study being published in the current issue of JCEM, as they show the potential utility of octreotide capsules in the treatment of adults with acromegaly," said Roni Mamluk, Ph.D., Chiasma's chief executive officer. "If approved, octreotide capsules would be the first oral somatostatin analog, and would give people with acromegaly a unique alternative to chronic injections that are the current standard treatment for this lifelong disease."
Based on these results, Chiasma intends to submit a New Drug Application to the FDA in 2015.