Data from a Phase 3 trial presented this week at ENDO2021 showed that octreotide capsules improved clinical symptoms and other patient-reported outcomes compared to long-acting injectable somatostatin receptor ligands (iSRLs) in patients with acromegaly. The data went on to show that 90% of patients receiving octreotide capsules elected to enroll in the open-label extension (OLE) study demonstrating that patients prefer this oral formulation. Chiasma, Inc. is marketing the drug as MYCAPSSA.
“These long-term safety and efficacy data demonstrate that MYCAPSSA maintains insulin-like growth factor 1 (IGF-1) levels in patients with acromegaly who previously required monthly injections for their disease,” says Endocrine Society member Susan L. Samson, MD, PhD, FRCPC, FACE, principal investigator of the trial. “The fact that 90% of the patients receiving MYCAPSSA in the CHIASMA OPTIMAL trial elected to enroll in the OLE demonstrates strong patient preference for MYCAPSSA.”
Results from the ongoing OLE study show that the average IGF-1 levels of all patients (n=19) treated with MYCAPSSA who completed the double-blind placebo-controlled (DPC) period in the CHIASMA OPTIMAL trial and continued into the OLE were maintained within normal limits at the end of the 48-week OLE period (0.91 at baseline and 0.90 × upper limit of normal (ULN) at week 48). All patients who responded to MYCAPSSA (IGF within normal limits) during the DPC period and enrolled in the OLE (n=14) completed the 48-week period and 93% (13/14) maintained their IGF-1 response within the normal limit at the end of this period. The safety profile of MYCAPSSA observed during the OLE was generally consistent with the safety observed in the CHIASMA OPTIMAL trial with the number of adverse events decreasing over the time of the OLE.