Engedi 1000 / Ensol Biosci - LARVOL DELTA

Ensol Biosciences announced on the 23rd that it had received approval from the Ministry of Food and Drug Safety on the 22nd for a Phase 3 clinical trial of its new drug candidate, Engedi1000 (development name: E1K). [Google translation] (HIT News) - "With this IND approval, the company will conduct a multi-center, randomized, double-blind Phase 3 study to evaluate the efficacy and safety of repeated E1K administrations in 363 patients with knee osteoarthritis."

New P3 trial • Osteoarthritis • Rheumatology

E1K, a disease-modifying drug candidate for knee osteoarthritis, alleviates pain and regenerates cartilage simultaneously by inhibiting TGF-β1-mediated SMAD1/5/9 signaling in osteoarthritis models. (PubMed, Osteoarthritis Cartilage) - "E1K promoted TGF-β1 signaling toward an anabolic profile by inhibiting catabolic signaling and regenerating cartilage, suggesting its potential as a disease-modifying osteoarthritis drug candidate with dual efficacy in pain relief and structural protection."

Journal • Immunology • Osteoarthritis • Pain • Rheumatology • ALK1 • COL2A1 • MMP13 • NGF • TGFB1 • TGFBR1

E1K Intra Articular(IA) Treatment for Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=120 | Completed | Sponsor: Ensol Bioscience | Recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of E1K After Single Dose in Patients With Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Ensol Bioscience

New P2 trial • Immunology • Osteoarthritis • Pain • Rheumatology