Clene's mid-stage ALS drug hits a brick wall, but can an 'efficacy signal' save the day?
ALS has proven to be one of the most challenging diseases for drug development, with only two approved medicines since the mid-1990s showing mild effects at slowing disease progression. Tuesday morning, another biotech attempting to create an ALS drug found itself in a position familiar to past players.
Clene Nanomedicine reported Phase II ALS results for its gold nanocrystal-based candidate, saying the compound did not reach statistical significance on the primary or secondary endpoints. And though Clene claimed to see positive signals in exploratory endpoints that could support an NDA, outside experts are unsure if anything can be taken away from the data.
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