STSA - Satsuma crashes 80% as migraine therapy STS101 fails phase 3 trial

Satsuma Pharmaceuticals ( NASDAQ: STSA ) migraine therapy STS101 did not meet the main goals of a phase 3 trial and the company said it does not plan to invest in commercializing STS101 and will explore alternatives to maximize value and cut cash expenditures.

STS101 is a nasal powder formulation of anti-migraine drug dihydroergotamine mesylate (DHE) administered via Satsuma's proprietary nasal delivery device,

The company said data from the study, dubbed SUMMIT, showed that STS101 was not statistically superior to placebo at two hours post-administration on the co-primary goals of freedom from pain and most bothersome symptom (from among photophobia, phonophobia and nausea).

STS101 did, however, show superiority differences versus placebo on freedom from pain and most bothersome symptom at all timepoints after two hours post-administration (3, 4, 6, 12, 24 and 48 hours), and on several secondary goals, including pain relief at 2 hours post-administration and all timepoints thereafter, the company added.

STS101 showed a favorable safety and tolerability profile, consistent with trial experience to date, according to the company.

Satsuma said that based on previous interactions with the FDA, it believes results from the STS101 phase 1 PK (pharmacokinetic) and ASCEND phase 3 long-term, safety trials will support NDA filing and approval.

In September, Satsuma reported results from ASCEND, which showed the treatment was safe, the main goal of the trial.

"We are surprised and disappointed that STS101 did not demonstrate statistically significant superiority over placebo at two-hours post treatment on the SUMMIT study co-primary endpoints," said Satsuma’s President and CEO  John Kollins.

Satsuma noted that it does not plan to invest in commercializing STS101.

As of Oct. 31, the company had estimated cash and equivalents of $59.4M.

STSA -80.25% to $0.80 premarket Nov. 14

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