After whipping up some giddy blockbuster expectations for their oral drug SAGE-217 in depression, Sage Therapeutics is back this morning with an early snapshot on new data for another mass market — insomnia.
Touting the drug’s ability to “rebalance fundamental brain circuitry,” researchers spotlighted a Phase I/II hit for several measures on improving the amount of sleep insomniacs can achieve.
As in all its earlier studies, Sage initially rolled through a tiny study that would have to be validated in a major late-stage program in order to pass muster at either the FDA or EMA. And one of the key goals, sleep onset after lights out, missed badly.
However, the biotech says its small study with only 45 patients scored a success on the primary endpoint, with two doses hitting 84.64% (p<0.0001) and 87.55% (p<0.0001), respectively compared with a median SE of 72.92% for placebo, for the amount of time spent asleep.
Time spent awake after going to sleep: 55.0 minutes (p<0.0001) and 42.5 minutes (p<0.0001) for -217, respectively, compared with 113.0 minutes for subjects on placebo.
Total sleep time jumped from 350.00 minutes in the placebo group to 406.25 (p<0.0001) and 420.25 (p<0.0001) minutes in the drug arms.
You don’t hear much about sleep drugs in the industry pipeline. Merck scored an OK for Belsomra a few years ago amid considerable skepticism that it could make much of a mark in a market dominated by cheap generics.
Sage CEO Jeff Jonas, however, has consistently pushed ahead in major fields convinced that the biotech has a completely new kind of remedy for these mass market indications. SAGE-217 — a follow-on from his lead drug -547 — is a GABAA positive allosteric modulator in trials for post partum depression, major depression, essential tremor and Parkinson’s disease. And he’s achieved enormous success with investors by keeping them whipped up by its prospects, even after going down to defeat on his first big objective.
There is a significant need to create an improved patient experience for the treatment of sleep dysfunction, and our work with the GABA mechanism identified an opportunity to develop a potential solution. These findings support the unique potential of SAGE-217 across a variety of psychiatric and neurological disorders with unifying focus on related symptoms, including disorders of mood, sleep and motor function.
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