Olix Anti-Hypertrophic Scar Treatment Receives US FDA Approval for Phase 2 Clinical Trial

[Asia Economy Reporter Hyunseok Yoo] Olig, which develops treatments for various intractable diseases based on RNA interference technology, a third-generation new drug development platform, announced on the 29th that it has received approval from the US FDA for the Phase 2 clinical trial plan of the OLX101A (hypertrophic scar and keloid treatment) program, which was submitted last month.

The Phase 2 clinical trial conducted under this IND approval will be carried out at five hospitals in the United States, targeting 20 to 30 patients with hypertrophic scars (who have undergone scar reconstruction surgery). Through randomized allocation, double-blind, and placebo-controlled trials, the efficacy of OLX101A in suppressing hypertrophic scar recurrence and its safety will be confirmed.

Hypertrophic scars are a condition in which collagen in the dermis excessively proliferates during the healing process of skin wounds caused by surgical operations or trauma, resulting in enlarged scars. It is a common condition experienced by more than 40% of patients who have undergone surgical procedures.

Hypertrophic scars not only cause pain but also lead to issues such as loss of confidence and social avoidance, making treatment essential. However, to date, there are no approved prescription drugs worldwide specifically for hypertrophic scar treatment. OLX101A, developed based on RNA interference technology, directly intervenes in the mechanism of scar formation to inhibit scar generation. If commercialized, it is expected to have the value of a first-in-class innovative drug, potentially gaining a competitive edge in the hypertrophic scar treatment market, the company said.

Donggi Lee, CEO of Olig, said, “We are pleased that the hypertrophic scar treatment program has smoothly entered Phase 2 clinical trials with the US FDA. Once human POC (proof of concept) of OLX101A is confirmed in this Phase 2 trial, we expect the value of not only OLX101A but also Olig’s other pipelines to be reassessed.” He added, “We will do our best to ensure that the pipelines we are developing can lead to technology exports through partnerships with global pharmaceutical companies.”