Ensol Biosciences said on the 15th that in the domestic phase 3 trial of its knee osteoarthritis treatment under development, "E1K (Engedi1000)," it completed the first patient dosing at Samsung Medical Center and began full-scale patient enrollment.
In this phase 3 trial, the efficacy and safety of repeated dosing of E1K in patients with knee osteoarthritis will be evaluated.
The safety evaluation phase that began with the first patient dosing involves six patients. Without a control group, they will receive E1K and undergo regular checkups and follow-up for 48 weeks after the first dose. The company said it plans to closely confirm the drug's initial safety in this phase.
The main trial is expected to enroll 358 patients aged 40 or older who have had knee pain for six months or more and have moderate knee osteoarthritis (KL grade 3) with osteophytes (bony spurs) confirmed on X-ray.
KL grade 3 patients have substantially progressed cartilage damage in the knee, and in many cases it is difficult to achieve sufficient effect with conservative treatments such as existing painkillers or physical therapy alone. Because there are few treatment options to choose before considering surgery, this patient group is seen as having strong demand for new therapies.
E1K is a synthetic peptide therapy that applies Ensol Biosciences' "Sinsunjo (signal pathway selective modulation)" technology. It is designed to selectively bind to a substance called TGF-β1 involved in the onset of osteoarthritis, blocking signals that induce cartilage damage while maintaining signals that protect cartilage.
The company explained that in this trial it plans to verify not only pain improvement but also changes in cartilage structure and the effect on suppressing disease progression through magnetic resonance imaging (MRI) and X-rays.
Knee osteoarthritis is a representative degenerative disease with a steadily increasing number of patients as the population ages. Ensol Biosciences plans to secure evidence of treatment effectiveness through this phase 3 trial and expand business development for overseas market entry and technology export.
Kim Hae-jin, CEO of Ensol Biosciences, said, "The first patient dosing at Samsung Medical Center means that the E1K phase 3 trial has officially begun," adding, "We will proceed with the safety confirmation phase and the main trial without a hitch to prove the efficacy and safety of E1K."