Ensol Biosciences said on the 23rd that the Ministery of Food and Drug Safety approved the phase 3 clinical trial plan (IND) for "E1K (Engedi 1000)," which is being developed as a treatment for knee osteoarthritis.
The phase 3 trial will enroll 364 patients with moderate (KL grade 3) knee osteoarthritis at 20 major hospitals nationwide, including Samsung Medical Center and Uijeongbu St. Mary's Hospital.
The research team plans to demonstrate efficacy and safety by comparing the E1K treatment group with the active comparator (HA) group in patients whose pain score during activity (Pain VAS) is 60 mm or higher.
This clinical trial is focused on proving the potential of a "disease-modifying osteoarthritis drug (DMOAD)" that treats the cause of the disease beyond simple pain relief.
The primary endpoint is to confirm the noninferiority of E1K compared with the active comparator in terms of pain and function improvement at 6 months after repeated E1K administration. The secondary endpoints evaluate efficacy in pain, function, and structural improvement at 12 months after repeated E1K administration. Kim Hae-jin, CEO of Ensol Biosciences, said, "E1K has demonstrated a dual effect on pain treatment and joint structure improvement in both preclinical and clinical studies," adding, "We will successfully complete this phase 3 trial to provide osteoarthritis patients worldwide with a fundamental treatment option that offers not only pain relief and functional improvement but also joint structure improvement."
Kim added, "There is currently no osteoarthritis treatment worldwide that can be expected to provide a fundamental cure," and noted, "If E1K passes phase 3, it is expected to become a groundbreaking game changer in the global market."