Favorable Pharmacokinetic, Safety, and Tolerability Results Support Advancing STS101 into Pivotal Phase 3 Efficacy Trial
South San Francisco, CA, July 8, 2019–Satsuma Pharmaceuticals, Inc. (“Satsuma” or “the Company”), a late-stage biopharmaceutical company developing STS101, (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced that a poster describing pharmacokinetic (PK), safety and tolerability data from a Phase 1 trial of STS101 will be presented at the American Headache Society’s Annual Scientific Meeting convening in Philadelphia, PA on July 11-14, 2019.
Title: Pharmacokinetics and Safety of Intranasal Dihydroergotamine Powder (STS101)
Presenter: Detlef Albrecht, M.D., Satsuma Pharmaceuticals, Inc.
The poster will be on display from July 11 at 4:30 p.m. through July 13 at 5:00 p.m. with lead author and Satsuma’s Chief Medical Officer, Detlef Albrecht, M.D., in attendance from 1:00 –2:15 pm on Saturday, July 13. Dr. Albrecht commented, “In this first-in-human trial, STS101 demonstrated rapid DHE absorption with the minimum threshold concentration we estimate to be necessary for drug efficacy achieved on average within ten minutes, sustained drug plasma levels, low PK variability, and favorable safety and tolerability. We believe the PK, safety and tolerability profile demonstrated by STS101 in this trial suggests that STS101 may exhibit robust clinical performance in the randomized, double-blind, placebo-controlled Phase 3 efficacy trial (the EMERGE™ trial) we are currently initiating.”
For information regarding the STS101 EMERGE Phase 3 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 late-stage biopharmaceutical company focused on developing STS101 as an important and differentiated therapeutic option for the acute treatment of migraine. STS101 is a novel and proprietary investigational drug-device combination product specifically designed to enable intranasal administration of the anti-migraine drug, dihydroergotamine (DHE), with a pharmacokinetic profile optimized to provide consistent and robust clinical efficacy. 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 will potentially 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 optimization, recently completed a Phase 1 clinical trial, and is currently in Phase 3 development.