- The study will start in mid-2021, with topline data expected in the second half of 2022.
- The new Phase 3 trial takes into account findings from the previous Phase 3 EMERGE study.
- STS101 showed numerical differences in favor of STS101 5.2 mg and 3.9 mg versus placebo. Still, it failed to achieve statistical significance versus placebo on freedom from pain and most bothersome symptom at two hours post-administration.
- Also, the company plans to start a Phase 1 trial in the second quarter of 2021 to evaluate the pharmacokinetics, safety, and tolerability of STS101 5.2 mg and two higher dose strengths.
- As of February 23, the company has enrolled over 275 subjects in its ongoing ASCEND long-term safety trial.
- STS101 5.2 mg has been well-tolerated to date, with low adverse event rates and no drug-related serious adverse events reported.
- Interim data show that anti-migraine activity was observed at STS101 5.2 mg dose at the two-hour time point.
- Concurrently, the company announced a securities purchase agreement with investors for $80 million private placement financing.
- Net proceeds from the private placement and its cash balance as of December 31, 2020, will provide cash runway into the second half of 2023
- Price Action: STSA shares are up 22% at $6.93 in premarket trading on the last check Monday.
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