SOUTH SAN FRANCISCO, Calif., April 21, 2023 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a development-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced that three abstracts highlighting STS101 were accepted at the American Academy of Neurology’s (AAN) 75th Annual Meeting. The 2023 meeting will be held in a hybrid virtual and in-person format in Boston, Massachusetts from Saturday, April 22 to Thursday, April 27, 2023. Full abstracts are now available on the AAN website.
Accepted Abstracts
| Title: | Interim Analysis of Subject Impression Data for STS101 From the Phase 3 Open-Label ASCEND Study |
| Session: | P13: Headache: Therapeutics 1 |
| Topic: | Headache |
| Program #: | P13.003 |
| Author(s): | Jessica Ailani, MD, MedStar Georgetown Headache Center Larry Charleston, IV, MD, MSc, FAHS, Department of Neurology & Ophthalmology at Michigan State University Detlef Albrecht, MD, Satsuma Pharmaceuticals, Inc. |
| Summary: | This abstract describes results from Satsuma’s Phase 3 ASCEND safety study of STS101. Patient global impression, ease-of-use impression, patient likelihood of use, and comparison of study medication with previously used migraine medication were collected at 3-, 6-, and 12-month timepoints and analyzed in the modified intent-to-treat population. All questions were assessed using a 5-point verbal Likert scale. |
| Conclusion: | Subject impression data through 12 months suggest that STS101 was perceived very favorably by subjects on multiple measures, including in comparison to their usual migraine medications. |
| Title: | Interim Analysis of Long-Term Safety and Tolerability Data of STS101 From the Phase 3 Open-Label ASCEND Study |
| Session: | P13: Headache: Therapeutics 1 |
| Topic: | Headache |
| Program #: | P13.004 |
| Author(s): | Stewart J. Tepper, MD, The Geisel School of Medicine at Dartmouth University Amaal Starling, MD, FAHS, FAAN, Mayo Clinic College of Medicine Detlef Albrecht, MD, Satsuma Pharmaceuticals, Inc. |
| Summary: | This abstract describes results from an interim safety analysis of Satsuma’s Phase 3 ASCEND safety study of STS101. This interim safety analysis included those participants who exclusively used the STS101, incorporating the second-generation nasal delivery device planned for commercialization. Safety evaluations included treatment-emergent adverse event (TEAE) assessments, physical exams, vital signs, nasal exams, electrocardiograms, and lab tests. |
| Conclusion: | The results of the ASCEND study show that STS101 was well tolerated when used long-term for the acute treatment of migraine attacks. |
| Title: | Interim Analysis of STS101 Nasal Safety Data From the Phase 3 Open-Label ASCEND Migraine Study |
| Session: | P13: Headache: Therapeutics 1 |
| Topic: | Headache |
| Program #: | P13.006 |
| Author(s): | Egilius L.H. Spierings, MD, PhD, Boston Headache Institute & MedVadis Research Corporation Detlef Albrecht, MD, Satsuma Pharmaceuticals, Inc. Alan Rapoport, MD, The David Geffen School of Medicine at UCLA |
| Summary: | This abstract describes results from an interim analysis of Satsuma’s Phase 3 ASCEND safety study of STS101. This interim analysis included participants exclusively using the STS101 incorporating the second-generation nasal delivery device planned for commercialization. Nasal safety assessments included nasal treatment-emergent adverse events (TEAEs), subjective assessments of nasal irritation, and a smell test (SIT). Objective nasal assessments were done by trained study personnel on a 4-point severity scale to document nasal erythema, edema, rhinorrhea, bleeding, and nasal mucosa ulcerations. |
| Conclusion: | Nasal safety data from 5,571 treated attacks demonstrate the safety and tolerability of STS101 for the acute treatment of migraine. |
About Satsuma Pharmaceuticals and STS101
Satsuma Pharmaceuticals is a development-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 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 robust efficacy, and sustained DHE plasma levels over time with low dose-to-dose variability. 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. However, disadvantages of current DHE liquid nasal spray and injectable products, including invasive and burdensome administration and/or sub-optimal clinical performance, have limited the widespread use of DHE. Featuring an easy-to-carry and easy-to-use 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 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
