Melior Pharmaceuticals I, a US-based mid-stage biopharma company, said that its insulin sensitizer, tolimidone (MLR-1023) has succeeded in a phase 2b trial in Type 2 diabetes mellitus (T2DM).
According to the company, tolimidone significantly reduced 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 sensitizer and modulator of lipid metabolism.
Melior said that the phase 2b study confirmed tolimidone’s ability to reduce fasting glucose and improve glucose tolerance over a 12-week treatment regimen.
Furthermore, the insulin sensitizer had shown 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. Melior said 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 (NASH).
Melior CEO Andrew Reaume said: “It is indeed unfortunate that these errors in clinical trial supplies have impaired the value of this important study.
“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. This, coupled with our growing understanding of the additional therapeutic benefits to the liver makes us very enthusiastic about tolimidone’s opportunity in NASH.”
The phase 2b trial had a total of 433 patients on metformin therapy with an HbA1c level >7.0% at screening. The subjects were randomly grouped to receive one of three doses of tolimidone (25, 50 or 100mg) or placebo, daily once for 12 weeks with continued metformin therapy.
The mid-stage study follows a phase 2a proof-of-concept study for tolimidone that was wrapped up in 2017 in which statistically significant glucose lowering was registered for fasting plasma glucose and area-under-the curve in a mixed meal tolerance test.
Apart from that, positive trends were observed in lipid parameters and body weight in the four-week phase 2a study.