In the Phase 2a trial of a two stage adaptive design in OA patients with pain, OLP-1002 shall be evaluated for analgesic efficacy, safety and therapeutic duration to confirm the target drug profiles as a first-line therapy for chronic pain. Long therapeutic duration is desired for good patient compliance, since OLP-1002 is currently developed for administration by subcutaneous injection.

People with a loss-of-function mutation in the SCN9A gene (SCN9A channelopathy) were found insensitive to pain but with other sensory functions undisturbed. Given that the SCN9A gene encodes the Nav1.7 sodium ion channel subtype, selective inhibitors of Nav1.7 have been implicated to show strong analgesic efficacy and good safety. However, small molecule inhibitors of Nav1.7 to date have repeatedly failed to clinically manifest strong efficacy and good safety. OLP-1002 is an SCN9A antisense pain killer devised to show strong efficacy and good safety by reproducing much of the clinical phenotype of people with SCN9A channelopathy.

"The global market of pain killers is estimated as large as ca 100 billion USD per year. However, the market potential is considered highly underestimated since the market is currently prevailed by cheap generic pain killers with limited efficacy and safety. The industry's quest for pain killers showing strong efficacy and good safety has not been very successful during the recent several decades. An unfortunate large scale quest would be COX-2 inhibitors. Lack of safe and effective pain killers triggered wide-spread abuse of opioid analgesics for chronic pain, which has caused tens of thousands of mortalities annually in the US alone. In this regard, unmet medical needs for pain killers with strong efficacy and good safety can never be overemphasized.", said Dr. Shin Chung, CEO of OliPass Corporation. "OLP-1002 manifested excellent safety in a UK Phase 1 study evaluated in a total of 116 healthy volunteers. In the meantime, an exploratory Phase 1b study in Australia suggested clues to strong efficacy and long therapeutic duration in OA patients. Contrary to people's perception, the efficacy of opioid pain killers would be modest if compared to the phenotype of people with SCN9A channelopathy. Based on nonclinical and clinical findings to date, we would expect strong efficacy, excellent safety and long therapeutic duration for OLP-1002 as a first-line therapy. Pain killers with strong efficacy and excellent safety, if provided at affordable cost, shall level up the plateau of the global pain market currently stagnant at ca 100 billion USD per year.", added Dr. Chung.

OliPass is planning additional Phase 2a trial in the US for chemotherapy-induced neuropathic pain (CINP). CINP may be taken as a good and realistic model system for neuropathic pain considering the mode of action of OLP-1002.

(About OliPass Corporation) OliPass Corporation is a public biotech company listed in KOSDAQ in South Korea (ticker: KQ244460). The company is developing RNA therapeutics based on its proprietary oligonucleotide platform called OPNA (OliPass Peptide Nucleic Acid). OPNA was derived from PNA by rational chemical modifications in order to improve the cell permeability and RNA affinity. For therapeutic intervention, OPNA potently binds to target pre-mRNA, induces exon skipping, and yields mRNA splice variant. Unlike other types of RNA therapeutics, OPNA does not require formulational aid for in vivo therapeutic activity.