Chiasma anticipates submission of NDA for Mycapssa by 2019-end
Chiasma previewed anticipated upcoming corporate milestones and commented on the significant progress made by the company in 2018."During 2018, we completed the required enrollment in both of our Phase 3 clinical trials of our investigational octreotide capsules product candidate, which we have conditionally trade-named Mycapssa, and with those trials progressing as planned, we believe we have set the stage for a catalyst-rich 2019 including the announcement of topline data evaluating Mycapssa's efficacy as potentially the first oral somatostatin analog for the maintenance therapy of adult acromegaly patients," said Mark Fitzpatrick, President and Chief Executive Officer of Chiasma. "As we enter the new year, our plans are firmly in place, assuming positive Phase 3 CHIASMA OPTIMAL data, to submit an NDA by the end of 2019 with an eye toward possible FDA approval of Mycapssa in mid-2020." "Multiple publications as well as initial screening data from Chiasma's MPOWEREDTM clinical trial have highlighted the undesirable treatment burden associated with monthly injectable somatostatin receptor ligands, the current standard of care in the chronic treatment of adults with acromegaly. Based on this data and feedback from physicians and patients, an alternative orally administered therapeutic option could alleviate this burden for some patients. We believe Mycapssa, if approved as the first oral somatostatin analog, has the potential to become a standard of care in acromegaly maintenance treatment. In anticipation of positive clinical trial results in 2019, we intend to meaningfully transition into commercial readiness planning in 2019," Mr. Fitzpatrick concluded.