OliX Pharmaceuticals Announces FDA Clearance of the IND to Evaluate the Efficacy of OLX10010 in Phase 2a Clinical Trial for Hypertrophic Scars
- Potential first-in-class treatment for hypertrophic scars with no FDA-approved medicines to-date
- Phase 2a trial follows the successful completion of OliX’s Phase 1 trial in the U.K. in November 2019
- OliX retains global rights to develop and commercialize OLX10010 outside Asia
SUWON, Republic of Korea, Oct. 30, 2020 (GLOBE NEWSWIRE) -- OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to evaluate the efficacy of OLX10010 as an adjunct therapy to reduce the recurrence of hypertrophic scars after scar revision surgery.
“We are pleased to receive FDA clearance to advance investigation of OLX10010 and look forward to working with investigators to begin enrolling patients in the trial,” said Dong Ki Lee, Ph.D., founder and Chief Executive Officer. “Treating and reducing hypertrophic scars following surgery remains a high unmet medical need and we are excited to continue our efforts to develop this pioneering therapy and bring it to patients in the U.S.”
Hypertrophic scarring occurs in 40% to 70% of patients following surgery and results from an overgrowth of collagen in the dermis (the layer of skin beneath the surface layer) that may cause functional impairment and cosmetic disfigurement.
The Phase 2a study is a prospective, randomized, double-blind, intra-subject, placebo-controlled study that will assess recurrence of hypertrophic scars at 24 weeks following scar revision surgery as measured by a patient and observer scar assessment (POSAS). The trial will enroll up to 20 patients across five sites in the U.S.
Asymmetric small interfering RNA
Asymmetric small interfering RNA (asiRNA) is the next generation of RNAi therapeutics that offers efficient gene regulation. In comparison to existing siRNA therapeutics, OliX Pharmaceuticals’ asiRNA shows comparable gene silencing and significantly reduce siRNA-mediated side effects such as off-target gene silencing and immune stimulation.
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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