Amryt Pharma Plc (NASDAQ:AMYT) has presented long-term from the 2nd year open-label extension (OLE) of its Phase 3 OPTIMAL trial of Mycapssa (octreotide capsules in acromegaly.
- The trial compared long-term safety and efficacy data of Mycapssa to placebo for maintenance of biochemical response in patients with acromegaly, a hormonal disorder in which the pituitary gland produces too much growth hormone during adulthood.
- The data demonstrated that 100% of evaluable patients who entered the 2nd year OLE phase of the study as responders - insulin-like growth factor 1 (IGF-1) within normal limits - maintained their long-term biochemical response at the end of the study.
- Related: Amryt Pharma's Q4 FY21 Sales, FY22 Guidance Shy Of Street Consensus.
- IGF-1 levels were stably maintained within normal limits at the end of the OLE period.
- Growth hormone (GH) levels also improved at the end of the OLE period.
- The long-term safety profile of Mycapssa during the OLE was consistent with that observed in prior studies.
- Price Action: AMYT shares are up 1.97% at $7.76 during the market session on the last check Wednesday.
