Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA) shares rose after the company announced Phase 1 trial of STS101 data showed that all three dose strengths administered with its improved 2nd-generation nasal delivery device were well-tolerated and achieved the target pharmacokinetic profile.
The San Francisco-based Satsuma, 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.
The Phase 1 data showed that all three dose strengths (5.2 mg and two higher dose strengths) administered with Satsuma’s improved second-generation nasal delivery device were well-tolerated and achieved the target pharmacokinetic profile.
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.
Said CEO John Kollins, "The totality of data generated in our STS101 development program, including these new Phase 1 data and improved delivered dose results, strongly support evaluating the 5.2 mg dosage strength of STS101 in the upcoming SUMMIT Phase 3 efficacy trial."
STSA shares gained 51 cents, or 10.4%, to $5.46.
