Clene claims its PhII MS tri­al, half its in­tend­ed size, cleared the pri­ma­ry goal. But can the biotech af­ford PhI­II?

Clene Nanomed­i­cine said its gold nanocrys­tal-based drug can­di­date, which failed an ALS tri­al last year, was bet­ter than place­bo in a mid-stage study of pa­tients with mul­ti­ple scle­ro­sis. But there are some big caveats to flag here.

The Phase II VI­SION­ARY-MS study en­rolled less than half (73 of 150) of the planned pa­tient pop­u­la­tion, which the biotech has pre­vi­ous­ly at­trib­uted to Covid-19. The tri­al was con­duct­ed in Aus­tralia, a point men­tioned dur­ing an in­vestor call when not­ing the study was main­ly white (95% of pa­tients). And it failed in the in­tent-to-treat group, on­ly pass­ing muster on the pri­ma­ry end­point af­ter ex­clud­ing a group of pa­tients.

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