Policy & Regulation
Melior Pharmaceuticals' reports results of phase 2b trial of Tolimidone for Type two diabetes mellitus
17 May 2019 -

United States-based Melior Pharmaceuticals' insulin sensitiser, tolimidone (MLR-1023), has succeeded in a phase 2b trial in Type two diabetes mellitus (T2DM), it was reported yesterday.

According to the company, the product significantly decreased HbA1c in comparison to placebo in the mid-stage trial as per the analysis of all patients who were subjected to the full course of treatment. The investigational drug is a Lyn kinase activator that plays the roles of a dual non-PPAR insulin sensitiser and modulator of lipid metabolism.

The company stated that the phase 2b study confirmed the product's ability to decrease fasting glucose and improve glucose tolerance over a 12-week treatment regimen. Furthermore, the insulin sensitiser had indicated a safety profile in the phase 2b study that was on par with that observed in previous clinical trials. However, the company revealed that there were errors in the clinical trial supplies, which indicate that the treatment effect could have been attenuated due to mix-ups in dosing. The firm stated that the full extent of the mistakes and the source of their origin are being probed. Before the completion of the phase 2b study in T2DM, Melior decided to extend the clinical development of tolimidone into nonalcoholic steatohepatitis.