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