US-based Melior Pharmaceuticals I has begun dosing in a Phase IIb trial aimed at evaluating the efficacy of MLR-1023, an oral insulin sensitizer, in adult patients with uncontrolled type 2 diabetes on metformin therapy.

MLR-1023 improves glycemic control by directly and selectively activating the Lyn tyrosine kinase enzyme, which has been shown to modulate insulin-signalling pathways independently of PPAR-related interactions.

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The trial is being carried out as part of a joint development effort between Melior and South Korea’s Bukwang Pharmaceutical Company.

A total of 400 subjects are expected to be enrolled in the 12-week treatment protocol across 61 clinical sites in the US and South Korea.

The Phase IIb trial follows a positive Phase IIa proof-of-concept study that the companies completed last year, in which statistically significant glucose lowering was achieved for both glucose parameters.

“We continue to expect MLR-1023 to represent a ground-breaking therapy as the first in a new class of insulin sensitizers that is not associated with the untoward effects of PPAR-active compounds.”

Additionally, positive trends were observed in lipid parameters and body weight during the four-week study.

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Melior Pharmaceuticals I CEO Andrew Reaume said: “Given the positive results we showed in our first study, we continue to expect MLR-1023 to represent a ground-breaking therapy as the first in a new class of insulin sensitizers that is not associated with the untoward effects of PPAR-active compounds.”

According to preclinical studies, MLR-1023 has the potential to lower blood glucose levels more effectively than existing therapies without the risk of hypoglycemia or weight gain.

MLR-1023, which improves beta cell function in animal models of diabetes and combines well with current anti-diabetes drugs, is expected to be dosed once a day.