Ensol Bioscience is developing a new drug, Engedi (E1K), to treat Osteoarthritis.
EnsoL Bioscience announced on the 9th that it applied for approval of Phase 1 trial of ENGINE 1000 for Osteoarthritis treatment to KFDA.
The peptide drug, Engedi 1000, selectively binds Smad1 / 5/8 pathway, which is associated with TGF-beta1, to promote cartilage tissue degeneration, and Smad2 / 3 pathway .
It is being developed as an innovative DMOAD drug for 'Single Drug - Dual Function' which induces cartilage tissue regeneration and simultaneously reduces the pain inducing factor NGF gene expression to reduce pain.
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 joints 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 investigate 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 regeneration was observed in the joints treated with Engedi 1000, while the control group showed no cartilage. In addition, the higher the drug concentration, the more clearly the cartilage regeneration effect was observed.
"The success of clinical trials is influenced by study design," said Moon Eun Jung, director of the Ensol Bioscience New Drug Research Center. It is important to establish an optimal clinical trial plan that accurately reflects the nature and nature of the drug. We have spent considerable time in designing the most suitable test plan for the ENGEDI 1000, along with ADM Korea, which has a lot of clinical trials for arthritis treatment 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 you get a positive result with your design, it can help you move your global technology."
The worldwide market for Osteoarthritis is a very large market of about 45.2 trillion won in 2018, and the average annual growth rate of the seven major markets in the world up to 2024 is expected to reach 8.1%.
"When Phase 1 clinical trials are completed, not only the basic human toxicity evaluation results but also the efficacy and biomarker evaluation results can be secured, so the DMOAD new drug will be exported to the global market." said Hae-Jin Kim ceo of Ensol Bioscience.