Satsuma Completes Enrollment in Pivotal Phase 3 EMERGE trial of STS101 for Acute Treatment of Migraine - Seite 2

The two co-primary endpoints of the EMERGE trial, both of which are assessed two hours following administration of study medication, are (1) freedom from pain, and (2) freedom from most bothersome symptom (MBS; from among photophobia, phonophobia, or nausea). Responder analyses will be conducted on these co-primary endpoints.  The trial is powered at greater than 99% on the freedom from pain endpoint and at greater than 95% for the MBS endpoint.

In addition, EMERGE is designed to prospectively evaluate the efficacy of STS101 on a number of secondary endpoints and in patient subgroups that could significantly enhance the differentiated clinical profile of STS101.

The EMERGE trial is the first of two pivotal Phase 3 trials Satsuma plans to complete in support of STS101 registration. In Q3 2020, Satsuma plans to initiate an open-label, Phase 3 safety trial of STS101 (the ASCEND trial).  The ASCEND trial will enroll up to approximately 300 patients who will acutely treat their migraines with STS101 on an ongoing and as-needed basis, with at least 150 patients completing 6 months of treatment and 50 completing 12 months of treatment.

The Company anticipates that data from the EMERGE trial, if successful, in conjunction with results from the ASCEND open-label safety trial, will support an New Drug Application filing in late 2021.

For further information regarding the STS101 Phase 3 EMERGE efficacy trial, see www.ClinicalTrials.gov, identifier NCT03901482:  A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine (EMERGE).

About Satsuma Pharmaceuticals and STS101

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical Company developing a novel therapeutic product for the acute treatment of migraine, STS101. STS101 is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE), which can be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be rapidly self-administered in a matter of seconds. The Company believes STS101 would, if approved, be an attractive migraine treatment option for many patients and may enable a larger number of people with migraine to realize the long-recognized therapeutic benefits of DHE therapy. STS101 has undergone extensive pre-clinical development, completed a Phase 1 clinical trial, and is currently in Phase 3 development.