Satsuma Pharmaceuticals announced that data from a portion of the Phase 3 ASCEND trial of the company’s STS101 dihydroergotamine (DHE) nasal powder where STS101 was delivered via a second generation device for the treatment of migraine did not reveal any significant safety concerns. Satsuma also said that efficacy was improved when subjects used the new device compared to the original device, an improvement that the company attributes to improved delivery of the powder formulation.
The company, which is calling the version of STS101 with the second generation device “STS101Mk2“, pointed out that 166 subjects used STS101Mk2 to treat a minimum of 2 migraine attacks per month on average for at least 6 months, which was greater than the number the FDA has said would be required for an NDA submission.
The Phase 3 SUMMIT trial of STS101, which was initiated in June 2021, is still ongoing as well. In September 2020, the company announced that the Phase 3 EMERGE trial of STS101 failed to meet its primary endpoints. Satsuma said that it anticipates results from the SUMMIT trial by the end of 2022 and plans to submit and NDA for the nasal powder in early 2023.
The ASCEND trial, which enrolled over 480 subjects, was initiated in August 2020, and the change of delivery device took place in the first half of 2021. Satsuma noted that ~19% of the patients enrolled did not have enough migraines to be counted in the exposure-over-time data, and those subjects were therefore disenrolled from the study.
Of 172 participants who used only STS101Mk2 for the treatment of more than 1,900 migraines, 34.2% achieved freedom from pain 2 hours post dose, and 53.4% achieved freedom from the most bothersome symptom 2 hours post dose, the company reported. According to Satsuma, the 2 hour freedom from pain rate for patients treating their first migraine after enrolling in the study with STS101Mk2 was 7.8 percentage points higher than for patients using STS101Mk1 for the first migraine. For 2 hour freedom from most bothersome symptom, the rate was 6.9 percentage points higher for those using STS101Mk2 for the first migraine.
Satsuma President and CEO John Kollins said, “The results reported today from this open-label, long-term safety trial in which subjects administered STS101 to treat their migraine attacks for as long as 18 months in a real-world setting, confirm the favorable safety and tolerability profile of STS101 observed to date in more than 1,600 clinical trial participants and provide important safety information for our planned NDA submission. Additionally, the efficacy signals observed with STS101Mk2, including the robust reported rates for freedom-from-pain and freedom-from-MBS by 2 hours post-treatment, are consistent with its demonstrated improved drug delivery performance as compared to STS101Mk1, which incorporated a first-generation nasal delivery device.”
Read the Satsuma Pharmaceuticals press release.
