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news.OliX Pharmaceuticals has received the phase I clinical trial authorization (CTA) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its anti-scar drug, OLX10010.
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OliX CEO Dong-ki Lee said: "The approval of this CTA marks an important milestone for OliX's RNAi therapeutic development, by demonstrating that OliX has met and qualified against the high standards of a European regulatory agency.
The detailed information on the trial has been posted in ISRCTN registry which is a global clinical trial registry.
Hypertrophic scar, the main indication of OLX10010, results from the over-growth of dense fibrous tissue that can develop during the wound healing process after a skin injury or surgery, which may cause functional impairment and cosmetic disfigurement. It is reported that approximately one-third of post-operative patients develop a hypertrophic scar within 12 months. Given the unmet medical needs with no FDA- approved drug, OLX10010 could be a promising therapeutic option for these patients.
Phase I study of OLX10010 in Korea was conducted by Hugel Inc., OliX's co-developer and exclusive distributor in Asia, and completed without any serious adverse events.
Covance, a global contract research organization and drug development services company, will conduct the Phase I trial in their specialized clinic, which is expected to be finished by the first half of 2019.