Daewoong Therapeutics, an affiliate of the Daewoong Group, said on Friday that it received approval from the Ministry of Food and Drug Safety (MFDS) for a phase 1 clinical trial plan for its diabetic retinopathy candidate, DWRX2008. 

DWRX2008 is a diabetic retinopathy treatment that Daewoong Therapeutics is developing in the form of nano eye drops "for the first time in the world" by changing the route of administration of oral SGLL-2 inhibitor Envlo (ingredient: enavogliflozin).

Daewoong Therapeutics plans to confirm the safety, topical tolerability, and pharmacokinetic characteristics of DWRX2008 in phase 1. The trial, which is scheduled to begin in the fourth quarter of this year, will include single and repeated doses, and the target population will be healthy Koreans and Caucasians, and is expected to conduct a multi-country phase 2 trial if successful.

The strength of Envlo, which has demonstrated equivalent efficacy at less than one-third the dose of existing SGLT-2 inhibitors, is expected to make an effective treatment option for diabetic retinopathy that occurs in the retina and posterior segment of the eye, the company said. DWRX2008 was selected as a non-clinical support project by the Korea Drug Development Foundation (KDDF) in April last year.

DWRX2008 is characterized by its ability to manage "ocular blood sugar," the underlying cause of diabetic eye disease that occurs in the retina and posterior segment of the eye. It delivers enavogliflozin to the posterior segment of the eye through intraocular administration, inhibits sodium-glucose cotransporter (SGLT)-2 expressed in the posterior segment of the eye to lower blood glucose in the posterior segment, normalizes abnormal energy metabolism to reduce free radical production, and inhibits vascular endothelial growth factor (VEGF) secretion to induce angiogenesis.

In preclinical studies, the drug demonstrated a reduction in macular edema comparable to that of the control drug aflibercept and confirmed sufficient drug delivery to the posterior segment of the eye in a close animal model.

Diabetic retinopathy is a fatal complication of diabetes that causes circulatory disorders in the microvasculature of the retina, resulting in decreased vision and blindness.

Currently, only antibody therapeutic injections -- which comprise a global market worth more than 10 trillion won (approximately $7.5 billion)  to prevent the production of neovascularization, the final pathology of the disease -- have been developed.

"DWRX2008 could be a game-changer for patients suffering from intractable eye diseases, replacing current intraocularly injected antibody therapies with better therapeutic effectiveness and ease of use," said Daewoong Therapeutics CEO Kang Bok-ki. "We also expect to provide a combination dosing option for patients who do not respond to existing antibody therapies or suffer from invasive administration methods."