Satsuma Pharmaceuticals announces STS101 Phase 1 clinical trial results in HEADACHE: Journal of Head and Pain

South San Francisco, California - Satsuma Pharmaceuticals, Inc. (hereinafter referred to as "Satsuma"; Nasdaq: STSA), a clinical-stage biopharmaceutical company, announced on January 28, 2020, that the results of a Phase 1 study on the pharmacokinetics (PK), tolerability, and safety of its lead candidate product STS101 (DHE or dihydroergotamine) for the acute treatment of migraines, administered as a nasal powder, were published online in the official peer-reviewed journal of the American Headache Society, "Headache: The Journal of Head and Face Pain."
This report includes the results of a Phase 1 open-label, two-part, active-controlled, three-period crossover study designed to compare the safety and PK of STS101, DHE liquid nasal spray (Migranal®), and intramuscular (IM) injection of DHE in healthy subjects.
The study authors concluded that STS101 demonstrated a favorable tolerability profile, achieving DHE plasma concentrations equivalent to IM DHE and superior to Migranal®. Based on the data from this study and results from other clinical trials using DHE (including injectable, liquid nasal spray, and oral inhalation DHE formulations), the authors stated that STS101 is expected to demonstrate rapid pain relief, functional improvement, and superior two-hour and sustained pain-free rates. STS101 is currently being evaluated as an acute treatment for migraines in the ongoing Phase 3 efficacy trial (EMERGE™ trial), and Satsuma plans to report top-line data later this year.
　
The American Headache Society's Headache: The Journal of Head and Face Pain included the following findings:

• • • STS101 demonstrated rapid absorption, achieving the average DHE plasma concentration threshold (1ng/ml) estimated by Satsuma to be the minimum necessary for efficacy, within 10 minutes.
    • The drug exposure was substantially greater than Migranal and equivalent to IM DHE, surpassing the exposure levels previously reported for the oral inhalation DHE candidate formulation (MAP0004) by approximately 30 minutes post-dose and at all subsequent time points. MAP0004 has previously demonstrated rapid onset of clinical effect and robust migraine treatment efficacy in a large double-blind placebo-controlled Phase 3 trial.
    • The PK variability of STS101 was lower than that of Migranal, suggesting that STS101 may offer more predictable, reliable, and robust clinical effects.
    • In STS101, the maximum DHE plasma concentration was sufficiently low to potentially avoid nausea or vomiting, common side effects associated with intravenous DHE administration.
    • The STS101 trial demonstrated a favorable tolerability profile, with all adverse events related to administration being mild and transient, associated with nasal administration or known effects of DHE.

The paper titled "A Phase 1, Randomized, Open-Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects" is accessible at the following link:https://headachejournal.onlinelibrary.wiley.com/doi/epdf/10.1111/head.13737

About Satsuma and STS101

Satsuma is a clinical-stage biopharmaceutical company developing a novel therapeutic (STS101) for the acute treatment of migraines. STS101 is a combination product consisting of a proprietary powder formulation of dihydroergotamine mesylate (DHE) and a single-use, pre-filled nasal delivery device that allows for rapid and easy self-administration. In developing STS101, the company has applied proprietary nasal drug delivery technology, powder formulation technology, and drug particle design technology to create a compact, easy-to-use non-injectable DHE formulation that can be self-administered in seconds. The company believes that if STS101 is approved, it could become an attractive treatment option for many patients, allowing more migraine sufferers to experience the long-term therapeutic benefits of DHE therapy. STS101 has undergone extensive preclinical development, completed Phase 1 clinical trials, and is currently in Phase 3 clinical trials.
Satsuma is headquartered in South San Francisco, California, and operates in both California and Research Triangle Park, North Carolina. For more information, please visit www.satsumarx.com.http://www.satsumarx.com/