June 22, 2021
South San Francisco, CA, June 22, 2021 – Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced that John Kollins, President and Chief Executive Officer, is scheduled to present at the SVB Leerink CNS Forum on Tuesday, June 29, 2021 at 3:40 PM Eastern Time. The conference will be held virtually with participants joining remotely on June 29th & 30th.
Date: Tuesday, June 29th, 3:40pm - 4:10pm (ET)
Title: Bringing DHE Back for Migraine
Speaker: John Kollins, President & CEO of Satsuma Pharmaceuticals
Format: Fireside Chat hosted by Marc Goodman, Senior Research Analyst
If you are interested in arranging a virtual one-on-one meeting, please contact your SVB Leerink representative or contact Corey Davis at LifeSciAdvisors.
About Satsuma Pharmaceuticals, STS101 and the SUMMIT Phase 3 Efficacy Trial
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product, STS101, for the acute treatment of migraine. STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE), administered via Satsuma’s proprietary 2nd-generation nasal delivery device. STS101 is designed to provide significant benefits versus existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages, that current DHE liquid nasal spray products and injectable dosage forms lack. Satsuma’s dry powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations which Satsuma believes is necessary for early efficacy, and sustained plasma levels over time with low dose to dose variability. STS101 also incorporates an improved 2nd-generation nasal delivery device designed to provide more consistent nasal dosing, irrespective of user administration technique. Although DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration processes and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring a compact and convenient dosage form, STS101 is designed to overcome these shortcomings and provide patients an improved therapeutic solution for acutely treating migraines that consistently delivers robust clinical performance.
Satsuma is initiating the SUMMIT Phase 3 efficacy trial, which is designed to evaluate the efficacy and safety of STS101 in treating migraine attacks. The SUMMIT trial is a multi-center, single-treatment, randomized, double-blind, placebo-controlled, parallel group study to be conducted in the United States which seeks to enroll approximately 1,400 migraine patients. The SUMMIT study is designed in accordance with FDA recommendations outlined in the FDA Guidance Migraine: Developing Drugs for Acute Treatment, February 2018. After establishing full eligibility, SUMMIT trial participants will be randomized (1:1) to receive either STS101 DHE 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication. The two co-primary endpoints of the SUMMIT trial are freedom from pain and freedom from most bothersome symptom (from among photophobia, phonophobia or nausea), both of which are assessed at two hours after administration of study medication.
Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.
INVESTOR AND CORPORATE CONTACTS:
Corey Davis, PhD
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
tom@satsumarx.com