OliX Pharmaceuticals Announces IND Submission to U.S. FDA to Evaluate the Efficacy of OLX10010 in Phase 2a Clinical Trial
SUWON, Republic of Korea, Sept. 24, 2020 (GLOBE NEWSWIRE) -- OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, announced today the submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to evaluate the efficacy of OLX10010 as an adjunct therapy to reduce the recurrence of hypertrophic scars after scar revision surgery.
Hypertrophic scars are the result of an overgrowth of collagen in the dermis (the skin’s next layer) that may cause functional impairment and cosmetic disfigurement. Hypertrophic scarring occurs in 40% to 70% of patients following surgery. Currently, there is no FDA-approved drugs and few treatments supported by well-designed prospective studies.
The purpose of this prospective, randomized, double-blind, intra-subject, placebo-controlled Phase 2a study is to determine the efficacy of OLX10010 in reducing recurrence of hypertrophic scars. The study will assess both the reduction and recurrence of hypertrophic scars after scar revision surgery. The entire trial will enroll up to 20 patients in five sites in the US. The Phase 2a trial follows the successful completion of OLIX’s Phase 1 trial in the U.K. in November of 2019.
“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 Dong Ki Lee, Ph.D., founder and Chief Executive Officer. “We look forward to working with investigators to advance OLX10010 into the clinic.”
About OliX Pharmaceuticals
OliX Pharmaceuticals is a clinical stage pharmaceutical company developing therapeutics against a variety of disorders by down-regulating expression of disease-causing genes, based on its own proprietary RNAi technology. The Company’s core RNAi platform, asymmetric siRNA (asiRNA), is a unique gene silencing technology based on RNA interference (RNAi), which is considered as the most efficient gene silencing technology. Based on asiRNA technology, OliX has developed cell penetrating asiRNA (cp-asiRNA), a therapeutic RNAi platform to effectively target locally administrable diseases, such as hypertrophic scar, dry and wet age-related macular degeneration (AMD), subretinal fibrosis, idiopathic pulmonary fibrosis (IPF), and neuropathic pain. OliX has also developed another therapeutic RNAi platform, GalNAc-asiRNA, to target a variety of liver diseases.
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