Melior Pharmaceuticals is happy that there are positive “signals” in its latest phase 2b diabetes test, but dosing mix-ups mean we don’t have a clear picture of what really happened as the company looks more toward the drug's future as a potential nonalcoholic steatohepatitis (NASH) therapy.
Here’s what happened: Its drug, a first-in-class insulin sensitizer known as tolimidone, was pitted against a placebo to see whether it could best the dummy therapy in lowering blood sugar levels with a treatment taken once a day for 12 weeks alongside the generic diabetes drug metformin.
The exact details have not been shared, and we’re only told that it “demonstrated significant reduction of HbA1c compared to placebo […] in an analysis of all subjects who completed the full course of treatment.”
Its statement adds: “Tolimidone continued to demonstrate an excellent safety profile consistent with previous clinical studies.”
But there’s a problem: The company says it “uncovered evidence of errors in the clinical trial supplies,” which may mean the treatment effect had been weakened by “dosing mix-ups.”
The company promises that the “full extent of these mistakes and the source of their origin are under investigation,” but a timeline on that and when the details of this trial will be shared have not yet been made public.
“It is indeed unfortunate that these errors in clinical trial supplies have impaired the value of this important study,” said Andrew Reaume, CEO of Melior. “Nonetheless, it is noteworthy that the drug signal emerges through the supply mix-ups and firmly establishes tolimidone as the first of a new generation of insulin sensitizers.”
Diabetes is, of course, a crowded market, with a mixture of generic meds, insulins, pills, inhaled insulins and more already on the market or in development.
To this end, Melior has its sights set on NASH, the fatty liver disease every life science company seems to want in on, as it hopes to broaden the drug’s prospects, and it’s currently prepping for a phase 2 of tolimidone in NASH. The biotech notes that it “has filed new patents related to the use of tolimidone in NASH where it expects to receive much longer market exclusivity compared to diabetes that relies upon older patents.”