[THE INVESTOR] OliX Pharmaceuticals said on Nov. 12 that its partner Hugel has received approval from Korea’s Ministry of Food and Drug Safety to begin phase 2a clinical study on its RNA interference-based therapy OLX10010 to treat hypertrophic scars.

OliX will receive milestone payments for the clinical trials and regulatory development from Hugel -- which in-licensed OLX10010 for Asian markets in 2013. 

The investigational agent is based on OliX’s patented platform technology called cell penetrating asiRNA, or cp-asiRNA, which is designed to suppress the production of disease-causing protein without transfection reagent and with lower side-effects risk than existing technologies.

“OLX10010 could be an effective and safe treatment option for numerous patients with hypertrophic scars who have not been properly managed due to lack of approved prescription medicines yet,” said OliX CEO Lee Dong-ki.

Hypertrophic scars result from the abnormal over-growth of dense fibrous tissues that can develop during the wound healing process after a skin injury or surgery, which may cause functional impairment and cosmetic disfigurement. Given the unmet medical needs with no FDA-approved drug, the global market potential is estimated at over US$5 billion.

This approval marks the first time the country’s health regulator has given the green light for phase 2 clinical trials of RNAi therapy.

For now, US biotech Alnylam Pharmaceuticals’ Onpattro is the first and only RNAi therapeutic that won marketing authorization from the US Food and Drug Administration and the European Commission.

OliX retains the global rights to develop and commercialize OLX10010, excluding Asian countries, held by Hugel.

The developing therapeutic programs of OliX beside anti-scar treatment include idiopathic pulmonary fibrosis, sub-retinal fibrosis and age-related macular degeneration.

By Park Han-na (hnpark@heraldcorp.com)