YD Life Science said that it has confirmed the efficacy of YD-312, a diabetic macular edema treatment candidate, and obtained statistically significant results through a phase 2a clinical trial.
The company had been conducting clinical trials in Korea and the U.S. to verify the efficacy and safety of YD-312 since 2018.
Diabetic macular edema is a complication caused by diabetes and is a very serious disease that causes abnormal retinal vascular permeability to increase, causing blood vessel internal material to flow out. Macular tissue located in the retina can swell and lead to decreased central vision and even blindness.
In the trial, the company orally administered YD-312 in low-, medium-, and high-doses to diabetic macular edema patients for 12 weeks to test the drug’s therapeutic effects.
“The summary of the results on the clinical study report, provided by the company’s designated clinical research organization in the U.S, showed that the post-dose vision in all YD-312 dose groups compared with pre-dose was statistically significant,” a company official said.
Also, the company found that the visual acuity was maintained, or the treatment efficiency improved significantly compared to the placebo group, the official noted.
During the clinical trials, researchers found no side effects or abnormal signs directly related to the clinical drugs, confirming that there were no abnormalities in terms of safety, he added.
Based on such results, the company expects the development process will progress smoothly and plans to start phase 2b clinical trials of the drug in treating patients with diabetic retinopathy.
“The company expects that it will be able to accelerate discussions for licensing out the candidate with big multinational pharmaceutical companies,” YD Life Science CEO Lee Jin-woo said. “We are receiving requests and reviews for clinical trial reports from multinational pharmaceutical companies, and expect very positive results soon.”
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