Ollipass Receives Approval for Phase 1b Clinical Trial of Non-Opioid Analgesic OLP-1002 in Australia

[Asia Economy Reporter Hyungsoo Park] OliPass announced on the 5th that it has received approval from the Australian Therapeutic Goods Administration (TGA) for the clinical 1b trial plan of the non-narcotic analgesic OLP-1002.

There is no analgesic that safely controls chronic pain and neuropathic pain. In advanced markets including the United States, the misuse and abuse of narcotic analgesics are causing social problems.

OLP-1002 is an RNA therapeutic using PNA artificial genes. Due to its excellent analgesic effect and safety, it is expected to have market competitiveness in intractable pain areas such as chronic arthritis pain, diabetic neuropathy, and pain caused by cancer treatment. Being a non-narcotic analgesic, it is anticipated to be welcomed in advanced markets.

The clinical trial, conducted under the management of the global Contract Research Organization (CRO) Novotec, will evaluate the safety and analgesic efficacy of OLP-1002 in 30 patients with chronic arthritis pain. The clinical efficacy results will be used as key reference data for future phase 2 clinical trials. It will also serve as essential data for technology export.

Confirming efficacy in patient clinical trials demonstrates that OliPass PNA can be developed as an RNA therapeutic. It is expected to be a stepping stone for OliPass to become a global RNA therapeutic development platform company.

Since being designated as a new drug candidate in 2016, OLP-1002 has been undergoing preclinical (in the United States) and phase 1 clinical (in the United Kingdom) trial evaluations with research funding support from the Korea Drug Development Fund (KDDF).

An OliPass official stated, "We plan to additionally develop OLP-1002, currently being developed as an injectable, into a patch formulation applied directly to the skin," and added, "We will maximize patient convenience and grow it into a global blockbuster drug."

In addition to the non-narcotic analgesic OLP-1002, OliPass is developing OLP-1003, a treatment for age-related macular degeneration, in an ophthalmic eye drop formulation, and a PCSK9 hyperlipidemia treatment in an oral dosage form. They are also developing an Alzheimer's treatment targeting the Tau protein.

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