Chiasma Inc CHMA has announced new data from the MPOWERED Phase 3 trial of Mycapssa as the first oral therapy to treat acromegaly.
- Chiasma presented the data at the Endocrine Society's annual meeting.
- The data from MPOWERED showed that Mycapssa improved clinical symptoms and other patient-reported outcomes compared to long-acting injectable somatostatin receptor ligands (iSRLs) in patients with acromegaly.
- Additionally, Mycapssa met the pre-specified non-inferiority margin compared to long-acting iSRLs in the maintenance of biochemical response.
- Data showed that Mycapssa demonstrated non-inferiority to iSRLs in maintaining a biochemical response; 91% of the Mycapssa patients maintained insulin-like growth factor 1 (IGF-1) response.
- The overall mean symptom score decreased from 4.5 to 3.5; the mean change from baseline was statistically significant and clinically meaningful.
- Overall, 80.4% of the randomized patients maintained or improved their symptoms score during the run-in phase compared to baseline.
- At the end of the RCT phase, 15% of patients reported breakthrough acromegaly symptoms in the octreotide capsules group and 31% of patients in the iSRLs group.
- Adverse event incidence and nature were similar to the known octreotide safety profile and acromegaly disease burden.
- Price Action: CHMA shares are trading 3.8% higher at $3.54 in the premarket on the last check Monday.
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