Satsuma Pharmaceuticals Announces Positive Pharmacokinetic, Tolerability and Safety Results From Phase 1 Trial of STS101 at Multiple Dose Strengths
(Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced positive pharmacokinetic, tolerability and safety results from a Phase 1 trial of STS101.
- (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced positive pharmacokinetic, tolerability and safety results from a Phase 1 trial of STS101.
- Based on results from this Phase 1 trial and other data, including preliminary results to date from the ongoing Phase 3 ASCEND long-term, open-label safety trial of STS101 5.2 mg, Satsuma is initiating its SUMMIT Phase 3 efficacy trial with the 5.2 mg dosage strength of STS101.
- As previously communicated, top-line results from the SUMMIT trial are expected in the second half of 2022.
- With the second-generation STS101 device and improved instructions-for-use, we expect subjects in SUMMIT will consistently self-administer the full DHE dose with less variability than in the previous EMERGE Phase 3 trial.