Glenmark's melogliptin set for Phase III studies
This article was originally published in Scrip
Glenmark's oral dipeptidyl peptidase IV (DPP IV) inhibitor for type 2 diabetes, melogliptin, is expected to enter Phase III studies by the end of the year.
The compound recently completed a 12-week Phase IIb trial in 494 patients with type 2 diabetes and demonstrated improved glycemic control in these patients, besides an "excellent" safety and tolerability profile. In addition, patients taking melogliptin experienced a low incidence of hypoglycemia and neutral effect on body weight.
Melogliptin 50mg twice daily produced a significant improvement in measures of pancreatic beta cell function (an increase in HOMA-β, suggesting enhanced insulin release) in the study, demonstrating potential for offering class leading improvements in the glycemic control and metabolic function, the company said
The 12-week, randomised, double-blind, placebo-controlled, parallel group study, saw melogliptin reduce HbA1c from baseline compared with placebo with a mean average reduction of 0.75% in patients receiving a 50mg twice daily dose (p<0001) and="" 0.60%="" in="" patients="" receiving="" 100mg="" once="" daily=""><.0001). in="" a="" subgroup="" of="" patients="" with="" higher="" baseline="" hba1c="" of="" 8.5-10%,="" melogliptin="" reduced="" hba1c="" from="" baseline="" when="" compared="" with="" placebo,="" with="" a="" mean="" average="" reduction="" of="" 0.88%="" and="" 1.05%="" in="" patients="" receiving="" 100mg="" once="" daily="" and="" 50mg="" twice="" daily="">
On whether melogliptin addresses concerns about certain DPP-IV inhibitors leading to a risk of pancreatitis in some patients, Glenmark's CEO, Glenn Saldanha, said that the company had not encountered any instances of pancreatitis with the 494 patients. "Glenmark will continue to monitor this aspect in clinical studies," Mr Saldanha told Scrip. Some international reports recently said that a study by researchers from the Larry L Hillblom Islet Research Center at UCLA found that sitagliptin caused abnormalities in the pancreas that could be recognised as risk factors for pancreatitis and with time, pancreatic cancer in humans.
Glenmark, which has recently received IND approval from the US FDA to carry out a clinical study in the US, said that Phase III studies for melogliptin would be designed to evaluate the compound both as monotherapy and in combination with other antidiabetic therapies in type 2 diabetes. Mr Saldanha said that the company was working on several combination therapies, but declined to divulge the details.
Mr Saldanha also said that with melogliptin's progress the company was now "a step closer" towards achieving its objective of becoming the first Indian company to have a "truly global innovative" drug for the world. Two other companies, Dr Reddy's Laboratories and Ranbaxy Laboratories (now owned by Daiichi Sankyo) already have compounds in advanced stages of development. While Dr Reddy's balaglitazone, an oral antidiabetic compound, is in Phase III, Ranbaxy Laboratories said earlier this year that it had commenced Phase III trials for its antimalarial combination, arterolane maleate plus piperaquine phosphate in India, Bangladesh and Thailand.
Glenmark also said that it continues to be in discussions with various licensing partners to take melogliptin forward. Glenmark and Merck Serono, a division of Merck KGaA, had in February last year ended their development agreement for melogliptin after Merck Serono decided to re-focus its portfolio and not invest any further into diabetes R&D.