Jeil Pharmaceutical said Monday that it expects to receive investigational new drug (IND) approval as its pre-clinical trial into JP-2266, a diabetes treatment, is running smoothly.
The Ministry of Food and Drug Safety designated the drug as an advanced medical technology development project last year.
JP-2266, a candidate drug for the treatment of type 1 diabetes mellitus, is an SGLT1/2 double inhibitor discovered by Jeil’s new drug research Team. Sanofi had licensed the same line of Sotagliflozin from Lexicon for 2 trillion won ($1.7 billion). However, the trial showed that JP-2266 had better preclinical efficacy and fewer side effects than Sotagliflozin.
As a result of various animal model tests with the company’s orally administered medication, the effect of lowering postprandial blood glucose level was superior compared to insulin injected medication, while hypoglycemia did not occur, either.
JP-2266, a low-molecular compound, is a best-in-class substance that has five times higher postprandial blood glucose lowering than that of Sotagliflozin. It also can best reduce HbA1c and does not produce beta ketone as compared with Sotagliflozin
To meet the unmet medical needs, the company has developed an oral drug that can dramatically improve the risk of hypoglycemia and insufficiency of injected medication. The company expects that the oral form can reduce insulin injections in patients with type 1 diabetes.
Insulin is currently the only treatment for type 1 diabetes, and there are no non-insulin drugs available to treat Type 1 diabetes. According to Zion Market Research worldwide, the sales of such insulin amounted to $27 billion in 2015 and were projected to exceed $ 43.6 billion in 2021.
“JP-2266 proved its excellent preclinical efficacy as a next-generation oral diabetes remedy,” said Kim Jung-min, director of Jeil’s research center. “Since the animal model has enough effect to replace insulin once a day with oral dosing, our company is doing its best to complete nonclinical and clinical development of the drug to reduce the inconvenience of injections.”