Ensol Bioscience is pushing for clinical development for the development of 'Engedi (E1K) 1000' candidate drug for degenerative arthritis. Ensol Bioscience recently announced that it has applied for approval of the Phase I clinical trial (IND) for the Engedi 1000 to the KFDA.
The peptide drug Engedi 1000 selectively inhibits the Smad1 / 5/8 pathway, which binds to TGF-beta1 and promotes cartilage tissue degeneration, and maintains the Smad2 / 3 pathway, which is the pathway that induces cartilage tissue regeneration I have.
DMOAD, which is a fundamental treatment using 'Single Drug - Dual Function' which induces cartilage tissue regeneration and simultaneously reduces the expression of NGF gene, (Disease-Modifying Osteoarthritis Drugs).
In order to investigate the pain relief efficacy of Engedi 1000, monosodium iodoacetate (MIA), which causes cartilage destruction and pain in rats, was administered into the knee joint, and after 5 days, Engedi 1000 was administered in the knee joint cavity at a single dose. The von Frey test showed pain relief from day 21 after the drug administration and was maintained until day 28. In addition, pain relief efficacy was stronger with higher drug concentration.
In order to examine the effect of cartilage regeneration, the knee was extracted and examined histologically at 28 days after the administration of the drug. As a result, cartilage tissue was regenerated in the joints treated with the ENGEDI 1000, while the control group showed no cartilage. The company explained that it confirmed the effect of cartilage regeneration, which is dependent on drug concentration.
In order to examine the effect of cartilage regeneration, the knee was extracted and examined histologically at 28 days after the administration of the drug. As a result, cartilage tissue was regenerated in the joints treated with the Engedi 1000, while the control group showed no cartilage. The company explained that it confirmed the effect of cartilage regeneration, which is dependent on the concentration of Engedi 1000.
Dr. Moon Eun Jung, director of the EnSol Bioscience Research Center, said, "The success of clinicaltrials depends on the study design. It is important to establish an optimal clinical trial plan that accurately reflects the nature and nature of the drug. We have devoted considerable time to designing the most appropriate test plan for the Engedi 1000 clinical trial. "
Dr. Jomi Hyun, managing director of ADM KOREA, will take part in the Engedi 1000 clinical trial. "We will perform pharmacodynamic evaluation (PD marker analysis), tolerability evaluation and exploratory evaluation (observation of structural changes of pain and articular cartilage) "If we get a positive result with the design, it can help transfer global technology."
The global market for degenerative arthritis is a huge market reaching 45.2 trillion won (approx. $ 40.6 billion, Korea Health Industry Development Institute) in 2018, and it is the largest market in the world (America, France, Germany, Italy, Spain, , Japan) is expected to reach an annual average growth rate of 8.1% by 2024.
Kim Hae-jin, CEO of Ensol Bioscience, said, "Once Phase I clinical trials are completed, not only basic human toxicity evaluation results but also efficacy and biomarker evaluation results can be secured.