Satsuma Pharma's Dry Powder Migraine Treatment Flops in Phase III Study
This morning, Bay Area-based Satsuma announced STS101 (dihydroergotamine (DHE) nasal), the company’s experimental powder formula for the treatment of acute migraine, failed to achieve statistical significance in the Phase III EMERGE study. STS101, a dry-powder formulation of dihydroergotamine mesylate, was being assessed at two different dosing strengths in the study. Both failed to meet endpoints, the company said.
Upon the release of the news, the company stock plunged to $4.71 per share from Wednesday’s close of $23.34.
The Phase III EMERGE 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. In addition, the EMERGE trial design incorporated a number of secondary endpoints and prospective evaluations of the clinical performance of STS101 in a number of patient subgroups.
In its announcement, Satsuma noted that STS101 did show numerical differences in favor of STS101 3.9 mg and 5.2 mg versus placebo on the pre-specified co-primary endpoints of freedom from pain and freedom from most bothersome symptom, but those differences were not enough to notch a clinical win. Satsuma added that both dosage strengths did demonstrate significant effects on both freedom from pain and most bothersome symptom by three hours post-dose and later time points.
The company said both STS101 dosage strengths were well-tolerated in the EMERGE trial, with low adverse event rates and no serious adverse events reported.
“We are surprised and disappointed that STS101 did not achieve statistical significance on the co-primary endpoints in our EMERGE trial,” Satsuma President and Chief Executive Officer John Kollins said in a statement. “On behalf of everyone at Satsuma, I’d like to thank the many people with migraine who participated in EMERGE as well as the staff at the trial sites for their dedication and diligence in completing the trial, despite the challenges posed by the ongoing COVID-19 pandemic.”
In its announcement this morning, Satsuma did not specify next steps for the migraine treatment asset. The company did not say whether or not it would scrap the study in its entirety, or opt to try again under different protocols. Satsuma said it will conduct further analysis of the EMERGE study and will provide a more detailed update on its business plans once those analyses are completed
As of June 30, Satsuma said it had cash, cash equivalents and marketable securities of $93.7 million.