OliPass Corporation, a South Korea based biotech specialized in the development of RNA therapeutics, announced that the dosing of pain killer OLP-1002 commenced for a Phase 2a trial in osteoarthritis patients with pain. The Phase 2a study was approved by the Australian regulatory agency in October last year.
The Phase 2a trial is of a two stage adaptive design. The first stage is an open label study to identify an optimum dose range of the efficacy profile, in which patients receive a single subcutaneous injection of 1 ~ 80 mcg (microgram) OLP-1002. The second stage shall be a placebo-controlled double blind study to evaluate two doses of OLP-1002 selected based on the findings from the first stage.
“A small number of patients have received a single injection of 1 mcg OLP-1002 during the past few weeks. Pain reduction has been found marked and persisting in those patients, although the therapeutic activity is supposed to be followed up for a month post dose.”, noted Dr. Nicholas Kim, FACR, VP and CMO of OliPass Corporation. “Even though 1 mcg OLP-1002 is being evaluated in a small number of patients by an open label design, the observed efficacy is encouraging. The efficacy appears much stronger than usual efficacies I used to see with various types of pain killers throughout my clinical practice for decades as rheumatologist and pain specialist. I am very much looking forward to unfolding the efficacy profile of OLP-1002 by a placebo-controlled double blind study as we are planning in the second stage of the Phase 2a study.”, added Dr. Kim.
The global market of pain killers is estimated to be as large as 100 billion USD per year. Considering the market is currently prevailed with cheap generic pain killers with moderate efficacy or compromised safety, however, the market potential is certainly far larger. Lack of safe and effective pain killers triggered the outbreak of opioid crisis. There are huge unmet medical needs for pain killers with strong efficacy and good safety.
People with a loss-of-function mutation of the SCN9A gene (i.e., SCN9A channelopathy) were found insensitive to pain but with other sensory functions undisturbed. Since the SCN9A gene encodes Nav1.7 sodium ion channel subtype, a selective inhibitor of Nav1.7 has been implicated to effectively and safely treat pain. Unfortunately, there are ca 10 sodium ion channels structurally indistinguishable with small molecule inhibitors. Although small molecule inhibitors of Nav1.7 have been avidly evaluated, none have manifested strong analgesic efficacy and good safety.
“OLP-1002 is an SCN9A antisense peptide nucleic acid (PNA) and selectively inhibits the expression of Nav1.7 sodium channel, and therefore expected to replicate much of the phenotype of people with SCN9A channelopathy. Early readouts from the ongoing Phase 2a trial are consistent with our expectations for OLP-1002 as a selective inhibitor of Nav1.7 sodium channel.”, said Dr. Shin Chung, CEO of OliPass Corporation. “Even though the early readouts may look very promising, the therapeutic profile of OLP-1002 has yet to be validated by a placebo-controlled evaluation in a larger number of patients.”, added Dr. Chung.
(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.