HK inno.N displays distinctive K-CAB clinical trial results
December 12, 2023
HK inno.N displays distinctive K-CAB clinical trial results
HK inno.N presents clinical trial results of nasogastric tube co-administration of K-CAB orally disintegrating tablets and immunosuppressants in kidney transplant patients
K-CAB ODT rapid dissolving properties in the nasogastric tube enables immediate injection administration and convenience
Drug to Drug Interaction studies show no effect on kidneys
K-CAB clinical trial results were presented by HK inno.N in both domestic and international conferences consecutively, which will assert K-CAB’s dominance in the market.
HK inno.N announced on December 12th, the presentation of 2 distinctive clinical trial results during the Kidney Week 2023 of the American Society of Nephrology and Asian Transplantation Week 2023.
The clinical trial results presented included the pharmacokinetic comparison results in K-CAB 50mg Orally disintegrating tablets when administered orally and when administered via the nasogastric tube and the DDI results when co-administered with immunosuppressants via a nasogastric tube.
The pharmacokinetic comparison and safety results of oral administration and administration via a nasogastric tube was presented during the 2023 Autumn Conference held by the Korean Society for Clinical Pharmacology on the 16th of November.
The study, led by Professor Jongryul Kim of Clinical Pharmacology at Inje University Busan Paik Hospital, confirmed the pharmacokinetic equivalence and safety of K-CAB 50mg Orally Disintegrating Tablets when administered orally and when administered via a nasogastric tube.
K-CAB Orally Disintegrating tablets dissolve rapidly when placed in the syringe which enables it to be injected via the nasogastric tube to the stomach. The rapid dissolving properties have shown to significantly improve the injection process when compared with other competitor products. Other tablet and capsule products require a longer period of time to dissolve and applied physical force and even then can still cause problems during injection.
The results presented will provide an additional administration method of K-CAB ODTs for patients who are receiving drug administration via nasogastric tubes, patients in the intensive care unit, patients with impaired consciousness and any patients who are unable to orally administer drugs.
Additionally, results comparing plasma concentration of immunosuppressants and K-CAB when the two were administered together in patients who received kidney transplants was also presented. The objective was to observe the safety of K-CAB in patients with kidney transplants.
Patients that have undergone kidney transplant are required to administer immunosuppressants regularly to prevent rejection. The plasma concentration level must be maintained at a certain level in order for the immunosuppressant to be effective and is monitored constantly. The exposure and the minimum plasma concentration of the immunosuppressant must be constantly monitored when being co-administered with other drugs.
Acid suppressants and or digestive medication is administered in order to prevent any potential side effects such as heartburn and digestive malfunctions.
The study results were presented by Professor Janghee Cho from the Kyungpoook National University Hospital nephrology department at the ASN 2023 and the ATW 2023 on the 2nd and 15th of November respectively.
The study consisted of 2 subject groups with kidney transplant history. One group was co-administered an immunosuppressant(Tacrolimus and Mycophenolate) and K-CAB and the other group was co-administered an immunosuppressant and a PPI. The plasma concentration level of the immunosuppressant was observed for 12 weeks.
The study results showed that K-CAB did not affect the minimum plasma concentration of immunosuppressants. The results also indicated that there were no signs of rejection or kidney function failure when K-CAB was co-administered. The results of this study will serve as a safety reference for K-CAB administration with patients with organ transplants.
HK inno.N’s Vice President of R&D Geun Seog Song, commented “K-CAB is leading the Korean P-CAB market and is differentiating itself from the competitors by conducting various clinical trials in many different areas. K-CAB will continue to produce clinical trial results and present those results in domestic and international academic conferences which will distinguish K-CAB from the others”
K-CAB is South Korea’s 30th novel drug and a GERD treatment drug belonging to the P-CAB category. Since its launch, it has accumulated KRW 493.5billion in prescription sales and has been the No.1 GERD treatment for the past 4 years. K-CAB has also been licensed out to 35 countries including the US and China in the form of finished product exports and or tech transfer.[End]
■ References – Study Results
1. Enhancing drug administration flexibility: Evaluation of pharmacokinetic properties of K-CAB orally disintegrating tablet (ODT) administered via nasogastric tube or oral dosing -- Presented at the 2023 conference of the Korean Society for Clinical Pharmacology and Therapeutics
- Lead researcher: Professor Jongryul Kim of Clinical Pharmacology at Inje University Busan Paik Hospital
2. Drug-drug interaction of potassium competitive acid blocker with tacrolimus and mycophenolate in kidney transplant recipients: a randomized controlled trial using smart clinical trial platform – Presented at Kidney Week 2023 of the American Society of Nephrology and Asian Transplantation Week 2023
- Lead researcher: Professor Janghee Cho of Nephrology at Kyungpoook National University Hospital
■ Terminology
▶PPI: Proton Pump Inhibitor
▶P-CAB: Potassium Competitive Acid Blocker
▶Nasogastric tube: A tube inserted to reach the stomach via the nose and esophagus.
■ K-CAB series
-K-CAB tablet 50mg (Launched in Korea in March, 2019), K-CAB tablet 25mg (Launched in Korea in January, 2023)
-K-CAB Orally Disintegrating Tablet 50mg (Launched in Korea in May, 2022)
- K-CAB Orally Disintegrating Tablet 25mg (Approved by Korean drug authorities in February, 2023)