Satsuma Pharmaceuticals, Inc. (“Satsuma”, San Francisco, CA, USA) (Nasdaq: STSA) was established in June 2016 with the purpose of globally expanding the Translational Research business of Shin Nippon Biomedical Laboratories, Ltd. (“SNBL”) by developing migraine therapeutics consisting of dihydroergotamine (“DHE”) and SNBL’s novel nasal delivery technology, STS101¹⁾.

Satsuma today announced positive PK, tolerability, and safety results from a Phase 1 trial of 5.2mg and to greater doses of STS101. All three doses were well-tolerated and achieved the target pharmacokinetic profile. Based on results from this Phase 1 trial and other data, Satsuma is initiating its SUMMIT Phase 3 efficacy trial with the 5.2 mg dose of STS101. Top-line results from the SUMMIT trial are expected in the second half of 2022.

For more information on this announcement, please visit Satsuma Press Releases here.

1) STS101

There are currently an estimated 39 million people in the U.S. suffering from migraine headaches, and the market for migraine therapeutics is reported to have reached $16 billion in 2017 in the US alone. A large number of patients are relatively young, between 20 and 40 years old, and there is an existing need for quick relief of potentially-disabling headaches. DHE is effective for non-responders of triptans, which are currently first-in-line therapies; however, the current liquid nasal spray is slow to absorb, taking at least 30 minutes to take effect, and the product is regarded to be unreliable due to its variability in absorption and the relatively low blood concentrations it achieves. The STS101, Nasal DHE product using SNBL's nasal delivery technology, enables fast and adequate absorption and is expected to meet the needs of patients.