Satsuma Pharmaceuticals Announces Enrollment of First Patient in the ASCEND Phase 3 open-label, safety trial of STS101

ASCEND results expected to support STS101 NDA filing in Q4 2021

SOUTH SAN FRANCISCO, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced the initiation of patient enrollment in the ASCEND trial,  a multi-center, open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine (DHE) nasal powder) as an acute treatment for migraine.

“We are pleased to have enrolled the first patient in our Phase 3 open-label, safety trial of STS101,” commented John Kollins, Satsuma’s President and Chief Executive Officer. “We anticipate that the results of the ASCEND trial will support the long term safety and tolerability of STS101 as an acute treatment for migraine when patients administer the product candidate on an as-needed basis.  The ASCEND trial is complementary to our STS101 EMERGE Phase 3 pivotal trial, which has completed the patient treatment phase and for which we expect to report topline results in late September or early October 2020.”

The STS101 ASCEND open-label, safety trial will enroll subjects between 18 and 65 years of age who have a history of migraine and will be conducted at geographically diverse sites located throughout the United States.  The primary objective of the trial is to evaluate the long-term safety of STS101 as an as-needed acute treatment for migraine.  Secondary outcome measures include efficacy evaluations, for example proportion of subjects free from pain and most bothersome symptom (from among photophobia, phonophobia and nausea) at multiple time points up to 48 hours following administration of STS101.  The trial is expected to enroll up to 300 subjects, with at least 150 subjects treating a minimum of two migraine attacks per month with STS101 over a six-month period and at least 50 participants over a 12-month period.  The Company anticipates that data from the ASCEND trial, in conjunction with results from the STS101 EMERGE Phase 3 pivotal trial, if successful, will support a New Drug Application filing in the fourth quarter of 2021.
                    
For further information regarding the STS101 Phase 3 ASCEND safety trial, see www.ClinicalTrials.gov, identifier NCT04406649:  A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine (ASCEND).