OliX Pharmaceuticals, a South Korean pharma company, has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) seeking its consent to begin a phase 2a clinical trial for OLX10010 in reducing the recurrence of hypertrophic scars after scar revision surgery.
The developer of RNAi therapeutics intends to assess the efficacy of OLX10010 as an adjunct therapy for hypertrophic scars for which there are no approved drugs in the US.
According to OliX Pharmaceuticals, hypertrophic scars are caused by an overgrowth of collagen in the dermis that may result in functional impairment and cosmetic disfigurement. Hypertrophic scarring is shown in 40% to 70% of patients after surgery, said OliX Pharmaceuticals.
The prospective, randomized, double-blind, intra-subject, placebo-controlled phase 2a study will evaluate the reduction and also recurrence of hypertrophic scars following scar revision surgery, said the South Korean pharma company.
The mid-stage clinical trial will have up to 20 patients across five sites in the US. It follows the completion of a phase 1 trial in the UK last November.
Dong Ki Lee – founder and CEO of OliX Pharmaceuticals said: “We are excited to continue our efforts to develop this pioneering therapy and bring it to patients in the US to address this high unmet medical need for treating and reducing hypertrophic scars,” said
“We look forward to working with investigators to advance OLX10010 into the clinic.”