Categories: Wire Stories

OliX Pharmaceuticals Announces IND Submission to U.S. FDA to Evaluate Safety and Tolerability of OLX10212 in Phase 1 Clinical Trial

SUWON, South Korea–(BUSINESS WIRE)–#AMDOliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, today announced the submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to evaluate the safety and tolerability of OLX10212 for the treatment of advanced age-related macular degeneration (AMD).

The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.

AMD is the most common cause of blindness in the industrialized world, which affects more than 170 million people worldwide. AMD presents in 2 forms, geographic atrophy (GA) and neovascular AMD. Although treatments exist for many patients with neovascular AMD, a substantial number of patients remain insufficiently treated, and there is no FDA-approved drug for GA up to date. Therefore, the development of novel and safe AMD treatments presents as an important unmet medical need that OliX addresses with the development of OLX10212 for both indications.

According to GlobalData, the global market for the treatment of AMD is expected to grow from USD 11.7 billion in 2022 to USD 18.7 billion in 2028.1)

�Although RNA interference (RNAi) technology has achieved great success in the treatment of liver diseases, its application to extra-hepatic organs is still in its infancy,” said Dong Ki Lee, Ph.D., Founder and Chief Executive Officer of OliX Pharmaceuticals. “We at OliX are committed to bringing innovative and safe treatments to this severely ill patient population with advanced AMD. We are excited about this submission to the FDA because it presents as an important milestone not only for OliX but also for the entire field of RNAi therapeutics development as it is the first ophthalmic RNAi therapeutics entering the clinical stage since 2015.”

In September 2020, OliX entered a licensing agreement with Théa Open Innovation, a French company dedicated to ophthalmology, to transfer the worldwide rights (excluding Asia-Pacific) to eye disease treatment programs including OLX301A (program name of OLX10212).

1) GlobalData, Pharma Intelligence Center, ‘Age-Related Macular Degeneration: Global Drug Forecast and Market Analysis to 2028’

Contacts

Media Contact:
Jiyoun Kim

OliX Pharmaceuticals PR

+82-2-3489-4801

ccnc@olixpharma.com
Learn more: https://www.olixpharma.com/eng

Alex

Recent Posts

Kweichow Zhenjiu Sweeps Double Silver Accolades at the Prestigious Hong Kong International Wine & Spirit Competition 2024

HONG KONG SAR - Media OutReach Newswire - 8 November 2024 - ZJLD Group Inc.…

2 hours ago

First Early Childhood Exhibition Atelier and Conference in Singapore

REACH, Singapore and Reggio Children, Italy present Mosaic of Marks, Words, Material SINGAPORE - Media…

2 hours ago

Trading fears demystified: expert strategies for overcoming barriers from global broker Octa

KUALA LUMPUR, MALAYSIA - Media OutReach Newswire - 8 November 2024 - Trading offers a…

3 hours ago

Home Action Party (HAP) Celebrates 10 Years of Innovation Transforming Over 500 Homes

SINGAPORE - Media OutReach Newswire - 8 November 2024 - Home Action Party (HAP) is…

3 hours ago

The Asia Pacific Enterprise Awards 2024 Regional Edition Recognizes Ariescope EL Mejor Trading Pte Ltd for its Achievements under its Fast Enterprise Category

SINGAPORE - Media OutReach Newswire - 8 November 2024 - The Asia Pacific Enterprise Awards…

3 hours ago

Application for clinical trial of AIM Vaccine’s human diploid rabies vaccine

An iterative process is highly effective in increasing the value of large items HONG KONG…

4 hours ago