OliX Pharmaceuticals Announces IND Submission to US FDA to Evaluate Safety and Tolerability of OLX10212 in Phase 1 Clinical Trial | DNA RNA and Cells

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

SUWON, South Korea I July 01, 2022 I Olix Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapies, today announced the submission of an Investigational New Drug (IND) application to the United States 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 United States.

AMD is the most common cause of blindness in the industrialized world, affecting more than 170 million people worldwide. AMD comes in 2 forms, geographic atrophy (GA) and neovascular AMD. Although treatments exist for many patients with neovascular AMD, a significant number of patients remain undertreated and there are currently no FDA-approved drugs for AG. Therefore, the development of new safe treatments for AMD presents itself as a significant unmet medical need which OliX is addressing with the development of OLX10212 for both indications.

According to GlobalData, the global AMD treatment market 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 disease, its application to extrahepatic organs is still in its infancy,” said Dong Ki Lee, Ph.D. , founder and CEO of OliX. Medications. “At OliX, we are committed to bringing innovative and safe treatments to this critically ill patient population with advanced AMD. We are excited about this FDA submission as it represents a significant milestone not only for OliX but for the entire field of RNAi therapy development, as it is the first RNAi-based ophthalmic therapy entering the clinical stage since 2015.”

In September 2020, OliX entered into 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 OLX10212) .

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

THE SOURCE: Olix Pharmaceuticals

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