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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