Chiasma Inc. (NASDAQ:CHMA) has announced encouraging top-line results from the global Phase 3 MPOWERED™ non-inferiority study. The clinical study evaluated MYCAPSSA® (oral octreotide capsules) in comparison with injectable somatostatin analogs (SSAs) in biochemical response maintenance in acromegaly patients.
Chiasma reports positive MPOWERED study results
The company designed the MPOWERED study to support the expected MYCAPSSA Marketing Authorization Application (MAA) in the EU. Currently, MYCAPSSA has approval in the US for long-term treatment maintenance in patients with Acromegaly that are unresponsive to injectable lanreotide or octreotide treatment. The MPOWERED clinical study compared long-term MYCAPSSA maintenance treatment to long-acting injectable octreotide and lanreotide autogel in patients that were previously unresponsive to these treatments. Following a six-month run-in, around 92 MYCAPSSA patient responders were randomized into a nine-month controlled trial and continued MYCAPSSA treatment or their previous injectable therapy.
Study results met the primary non-inferiority endpoint with 91% of the patients that received MYCAPSSA maintaining insulin-like growth factor 1 (IGF-1) responses. Most importantly MYCAPSSA maintained a median IGF-1 around normal limits relative to injectable therapy.
Chiasma CEO, Raj Kannan said that they are delighted with the positive top-line data from the MPOWERED trial that showed non-inferiority compared to long-acting SSAs. Also, the results strengthened the available robust MYCAPSSA clinical data set and offered significant information in the treatment of acromegaly patients. Kannan added that in light of the positive data the company is planning to submit an MAA for MYCAPSSA to the EMA by mid-next year. The CEO said that they are pleased to report the initial top-line data and more analyses for the study results are underway with plans to release the full study data set in 2021.
MYCAPSSA shows a favorable safety profile
Lead study investigator, Maria Fleseriu, said that they are excited with the study achieving its primary non-inferiority endpoint relative to long-acting SSA injectables. She added that the results demonstrate that patients that changed to oral octreotide from injectables can still attain comparable safety and efficacy. MYCAPSSA safety profile was consistent with the known octreotide safety profile without adverse injection reactions.