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Satsuma Pharma’s STS101 flunks late-stage migraine study, shares down

September 10, 2020

Thinly traded micro cap Satsuma Pharmaceuticals (NASDAQ:STSA) tanks 84% premarket on robust volume in reaction to an unsuccessful Phase 3 EMERGE efficacy trial evaluating STS101 (dihydroergotamine) (DHE) as an acute treatment for migraine.

Topline data did not show statistically significant differences between STS101 3.9 mg and 5.2 mg dosage strength and placebo on co-primary endpoints of freedom from pain and most bothersome symptom (such as photophobia, phonophobia and nausea) at two hours post-administration.

The trial was statistically designed for greater than 99% power for the freedom from pain endpoint and greater than 95% power for the freedom from most bothersome symptom endpoint.

Though the data demonstrated numerical differences in favor of both the STS101 doses, versus placebo, as well as significant effects on both co-primary endpoints by three hours post-dose and later time points.

Both the STS101 dosage strengths were well-tolerated with low adverse event rates and no serious adverse events reported.

Further analysis of EMERGE trial data is ongoing, and Satsuma expects to provide a more detailed update on its business plans after these analyses are completed.

STS101 is a drug-device combination of dry-powder formulation of DHE which can be self-administered with a pre-filled, single-use, nasal delivery device.

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