When your only tool is a hammer, every problem looks like a nail. In Lipocine’s case, the hammer is testosterone-raising agents; the group's Tlando has been knocked back twice in hypogonadism, so the Nash nail no doubt looked like it needed some bashing. A 41% share increase today suggested that Lipocine had been successful with LPCN 1144 in a phase II Nash trial, but there are plenty of reasons to wait before declaring this trial a success, including missing patients, small patient numbers, and the lack of placebo control. Lipocine reported eight-week data from seven patients in a 16-week study of LPCN 1144 in hypogonadal men who had baseline liver fat of at least 10%, putting them at risk of developing Nash. Two patients who had completed eight weeks' treatment were not included in the analysis because they were unable to schedule an MRI-PDFF appointment. In the seven men who were evaluable the study found an absolute mean reduction from baseline of 7.6% liver fat, and demonstrated a 38% relative mean liver fat reduction from baseline as measured by MRI-proton density fat fraction. The baseline liver fat of these patients was 21%. The study is scheduled to enrol 36 patients in total.
|Upcoming phase III results in Nash|
|Ocaliva||Intercept||Data from Regenerate trial||Q1 2019|
|Selonsertib, GS-0976, GS-9674||Gilead Sciences||Data from Stellar trials||H1 2019|
|Cenicriviroc||Allergan/Takeda||Data from Aurora trial||Mid-2019|
|Elafibranor||Genfit||Data from Resolve-It trial||Q4 2019|