(Health Korea News / Soon-ho Lee) Jeil Pharmaceutical has changed. We are focusing our efforts on developing new drugs, breaking away from the business structure centered on introduced products that has been in place for decades. While the first in-house developed new drug, the potassium-competitive gastric acid secretion inhibitor (P-CAB)-based gastroesophageal reflux disease treatment ‘JAQBO (ingredient name: Jastaprazan)’, was launched last month, a new diabetes drug is also undergoing phase 2 clinical trials. As it nears the end, expectations for the company’s second new drug are growing.
According to the Ministry of Food and Drug Safety on the 13th, Jeil Pharmaceutical completed the selection of final subjects for the ongoing phase 2 clinical trial of ‘JP-2266’ in patients with type 2 diabetes in September.
‘JP-2266’ is an oral treatment that simultaneously inhibits sodium and glucose co-transporters types 1 and 2 (SGLT-1 and 2), a mechanism that lowers blood sugar by inhibiting glucose reabsorption in the kidney and excreting glucose through urine. It is a new drug candidate.
It is a drug to be taken 2 tablets once a day. In this phase 2 clinical trial, Jeil Pharmaceutical measured glycated hemoglobin (HbA1c), fasting blood sugar (FPG), fasting insulin, and average postprandial blood sugar (postprandial blood sugar) of subjects who took ‘JP-2266’. We plan to evaluate changes in PPG), etc. The primary endpoint is the change in glycated hemoglobin at 12 weeks of administration.
Considering that the drug administration period is up to 12 weeks, it is expected that the trial will be completed within this year.
A competing drug with the same mechanism as ‘JP-2266’ is Lexicon’s ‘Zynquista’, which has received product approval in Europe. ‘JP-2266’ was confirmed in animal testing to be able to reduce insulin usage to a greater extent than ‘Zinquista’.
In particular, unlike ‘Zinquista’, beta-ketone, which has been identified as the causative agent of diabetic ketoacidosis (DKA), did not appear in animal tests for ‘JP-2266’, attracting greater attention.
Previously, Jeil Pharmaceutical received approval for a phase 1 clinical trial plan for ‘JP-2266’ from the European Medicines Agency (EMA) in August 2020, and tested JP-2266 compared to placebo in 80 healthy men aged 18 to 50 in France. Safety and tolerability have been evaluated. The phase 1 clinical trial is understood to have ended in 2022, but the company did not separately announce the results after the clinical trial was completed.
Meanwhile, Jeil Pharmaceutical became the first company to join the ranks of new drug developers by launching ‘Zacubo’ last month.
‘Jacubo’ is a P-CAB-based gastroesophageal reflux disease treatment approved by Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, as Korea’s 37th new drug in April. It is the third P-CAB new drug launched in Korea, following HK Innoen’s ‘K-CAB (ingredient name: Tegoprazan)’ and Daewoong Pharmaceutical’s ‘FEXUCLUE (ingredient name: Fexuprazan)’. Both raw materials and finished products are produced by Jeil Pharmaceutical and jointly sold by Jeil Pharmaceutical and Dong-A ST.
In addition to ‘Zacubo’ and ‘JP-2266’, Jeil Pharmaceutical is also speeding up the development of ‘JPI-289’, a new stroke treatment drug.
‘JPI-289’ is an innovative new drug that prevents brain cell damage caused by the thrombolytic drug tissue plasminogen activator (t-PA) or thrombectomy. It has a new mechanism of action that blocks enzymes involved in DNA damage and nerve cell death caused by cerebral ischemia.
Jeil Pharmaceutical’s explanation is that the phase 2a clinical trial has now been completed, and a positive treatment trend has been confirmed in the primary efficacy endpoint (change ratio of cerebral infarction at 4 days, p=0.056), secondary efficacy endpoint, and safety evaluation items. am.
Jeil Pharmaceutical plans to pursue joint development partnerships and overseas technology transfer in relation to ‘JP-2266’, while also pursuing research on additional indications, such as non-alcoholic steatohepatitis (NASH) and heart failure treatment.
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