Daewoong confirmed the approval from the Ministry of Food and Drug Safety (MFDS) for a phase 1 clinical trial plan for its investigational product DWRX2008. The inaugural study, set for Q4 of 2023, will assess the safety and pharmacokinetics of DWRX2008 across diverse dosages in both healthy Korean and Caucasian subjects.
DWRX2008 is an innovative nanoparticle eyedrop adaptation of Envlo®(enavogliflozin), which tackles the challenge of poor retinal drug absorption from oral use. It is thought to maintain the dosage efficiency of enavogliflozin, delivering therapeutic effects at just 1/30th the dose of leading SGLT2 inhibitors. Last April, DWRX2008 was granted Korea Drug Development Fund(KDDF) designation for advanced preclinical development. Notably, recent findings indicate its effectiveness in reducing central macular thickness and vascular leakage exclusively in the eyes of diabetic primates that received the treatment, with no such effects observed in untreated eyes.
Diabetic retinopathy, a microvascular complication arising from hyperglycemia and oxidative stress, remains a leading cause of global blindness. While anti-VEGF eye injections serve as the primary treatment and command a $9 billion market, their costs and invasive nature highlight the need for a more affordable and patient-friendly alternative to complement existing therapies.
Bokki Kang, CEO of Daewoong Therapeutics, stated, "DWRX2008 offers a hopeful solution for persistent posterior eye diseases, particularly for those hesitant or unresponsive to eye injections. We're also exploring combination treatment options." He added, "Our dedication to advancing drug delivery technology remains strong as we aim to meet diverse medical needs and uplift patient care worldwide."