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

More than 1,140 patients randomized and topline results expected in second half 2020

SOUTH SAN FRANCISCO, Calif., June 01, 2020 (GLOBE NEWSWIRE) -- Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today reported completion of enrollment and randomization in its EMERGE pivotal Phase 3 efficacy trial of STS101 (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine.

Satsuma's President and Chief Executive Officer, John Kollins commented, “We are very pleased to have achieved this important milestone.  We look forward to reporting EMERGE topline results in the second half of this year that we anticipate will further underscore the differentiating features of STS101, including robust anti-migraine activity and favorable tolerability that result from achieving DHE blood levels within what we believe is an optimal therapeutic window.“

“In addition, despite COVID-19 headwinds, our team has executed well, and we continue to advance development of STS101 per our plan and timelines.  We remain on track to intiate enrollment in Q3 in the second STS101 Phase 3 trial, an open-label, multiple-administration safety trial (the ASCEND trial) in which patients will acutely treat their migraine attacks with STS101 on an ongoing and as-needed basis.”

About the EMERGE trial and STS101 Clinical Program

Designed to evaluate the efficacy, safety, and tolerability of STS101 (DHE nasal powder) as an acute treatment for migraine, the EMERGE trial is a multi-center, randomized, double-blind, placebo-controlled, parallel group trial in more than 1,140 migraine patients that is being conducted at 121 sites located across 32 U.S. states.  EMERGE is designed in accordance with U.S. FDA recommendations outlined in its 2018 guidance document, Migraine: Developing Drugs for Acute Treatment. Based on dialogue with the FDA, the Company believes that EMERGE, if successful, will fulfill the regulatory requirement for demonstration of STS101 efficacy.

After establishing eligibility during a 28-day screening period, EMERGE trial participants were randomized (1:1:1) to receive one of three treatments: STS101 3.9 mg, STS101 5.2 mg, or placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication.  Following randomization, trial participants have up to 56 days in which to treat a qualifying migraine attack; following treatment of a qualifying attack, patients return to their trial sites for a final follow-up visit.