OliX Announces Clinical Candidate Nomination for the Treatment of Geographic Atrophy
- Category: DNA RNA and Cells
- Published on Friday, 18 January 2019 09:00
- Hits: 645
SUWON, South Korea I January 18, 2019 I OLX10020, a cell-penetrating asymmetric siRNA ("cp-asiRNA") against a novel target (Undisclosed) for treatment of Geographic Atrophy ("GA"), proved effective in both Dry and Wet AMD animal models and to be submitted an IND application to the FDA to initiate a Phase 1 trial this year.
OliX Pharmaceuticals, Inc. (Kosdaq: 226950), a leading developer of RNAi therapeutics, today announced the nomination of OLX10020 as a clinical candidate for the treatment of Geographic Atrophy ("GA"), which is the most severe and advanced form of dry Age-related Macular Degeneration ("AMD").
OLX10020 targets an undruggable gene involved in GA, identified by Dr. Jayakrishna Ambati, a professor at University of Virginia, School of Medicine. Results from animal studies support that OLX10020 can specifically target patients with GA among dry AMD patients. Furthermore, OLX10020 has been proved effective in wet AMD animal models, indicating that it is a potential first-in-class drug which can treat both dry and wet AMDs.
OLX10020 has completed preliminary safety evaluation and GLP toxicology studies will be commenced soon at Covance (Madison, WI, USA). An IND application is planned to be submitted to the FDA to initiate a Phase 1 within this year.
Dong-Ki Lee, the founder of OliX Pharmaceuticals, Inc., stated, "OLX10020 is a first-in-class siRNA therapeutics with novel mechanism of action, that can target both dry and wet forms of AMD. Successful development of OLX10020 will provide new hope for the patients suffering from GA, a devastating disease currently no effective treatment is available."
About Age-Related Macular degeneration (AMD)
- Occurs when the small central portion of the retina, known as the macula, deteriorates
- The leading cause of severe vision loss in people over age 60 in developed countries
- Two types: wet AMD (10%) & dry AMD (90%)
- In USA, 175 million patients affected by AMD in 2014 (Source: All about vision, Understanding AMD 2014)
- Global wet AMD market: $ 7.65B in 2015
- By 2025, expected dry AMD market: $ 6.58B (Source: Visiongain 2016)
- 98% of wet AMD patients were reported the onset of dry AMD in seven years (Source: Ophthalmology. 2012 Jul;119(7):1388-98., Ophthalmology. 2013 Nov;120(11):2292-9)
--> Unmet medical needs for the development of a drug that can treat both wet and dry AMD exist
- Expected to grow to approx. about 11.6 B by 2026 (Source: Global Data 2018, 7 major countries)
OliX Pharmaceuticals, Inc.
OliX 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 is currently developing novel therapeutic programs for treatment of various diseases with high unmet medical needs, including hypertrophic scar, dry & wet age-related macular degeneration (AMD), subretinal fibrosis, and idiopathic pulmonary fibrosis (IPF).
SOURCE: OLiX Pharmaceuticals