Satsuma’s second chance nears readout

Two years after Satsuma's inhaled acute migraine treatment STS101 failed in phase 3, the developer is closing in on a second attempt at success. The pivotal Summit trial is due to read out next quarter, and data released yesterday from a separate open-label study bode well, analysts believe. Ascend was primarily designed to measure safety, but secondary measures echo those being chased in Summit. 34% of patients reported freedom from pain at two hours and 53% reported freedom of bothersome symptoms, comparing favourably to other acute migraine drugs, Evercore ISI wrote. Replicating those numbers in the double-blind, placebo-controlled Summit will be tough, however; Satsuma blamed the previous phase 3 failure primarily on a device problem which caused under-dosing. The sellside is optimistic that the company has got it right this time, and a doubling in Satsuma’s share price over the last three months suggests that some investors consider the outcome worth a bet. Still, the developer’s market cap is still a quarter of what it was before the first blow up, and the acute migraine space has only got more competitive in the meantime. Delivering a phase 3 hit will be far from the end of this journey.

Satsuma's pivotal programme 
Trial Description Outcome 
Summit (n=1,400) Single dose of STS101 in acute migraine; primary endpoints 2hPF and 2hMBS response rates vs placebo Results due Q4'22
Ascend (n=482) Single arm, open-label ph3 primarily measuring safety, with 2hPF and  2hMBS response rates as secondary endpoints June 2022 analysis: safety in line with previous trials; 34.2% 2hPF and 53.4% 2hMBS
Emerge (n=1,200) Low and high doses vs placebo in acute migraine; primary endpoints 2hPF and 2hMBS response rates vs placebo Failed Sept 2020 (2hPF 19.3% vs 14.8%, p=0.11)
Note: 2hPF = freedom from pain by 2 hours post-treatment; 2hMBS = Freedom from most bothersome symptom by 2 hours post-treatment. Source: company communications. 

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