OliPass Discloses Painful but Hilarious Clinical Findings from a Phase 2a Trial in OA Patients with Nav1.7 Selective Inhibitor OLP-1002

13 Nov 2023
www.prnewswire.com
Clinical ResultPhase 2Phase 1OligonucleotidesiRNA
SEOUL, South Korea, Nov. 13, 2023 /PRNewswire/ -- OliPass Corporation, an RNA therapeutics platform company, disclosed uncanny clinical findings from a multi-center Phase 2a trial with Nav1.7 selective OLP-1002 in osteoarthritis (OA) patients with moderate to severe pain in Australia with Novotech. The Phase 2a trial consists of an open label dose range finding study (stage 1) and a placebo-controlled double blind study (stage 2).
1. Stage 1 Open Label Study
In this dose range finding study, patients were administered with a single subcutaneous injection of 1, 3, 10, 25, 50 or 80 microgram (mcg) OLP-1002, and then subjected to pain assessment for 4 weeks. 1 mcg OLP-1002 turned out to be most effective, showing average pain reductions of 50 ~ 70% by WOMAC Pain and 60 ~ 80% by VAS over the period of 4 weeks. All the five patients on 1 mcg OLP-1002 effectively responded to the medication. Other doses were also effective but with large inter-subject variability. OLP-1002 shows a bell-shape dose-response pattern in cells and higher dose may not be translated into stronger analgesic efficacy.
2. Stage 2 Placebo-controlled Double Blind Study
Patients received a single subcutaneous injection of placebo, 1 mcg or 2 mcg OLP-1002, and then were subjected to pain assessment primarily by WOMAC Pain and VAS for 6 weeks post dose. An interim analysis was conducted for the first 30 patients (10 patients per group) to estimate due statistical power for efficacy. The interim analysis suggested that the study be properly powered for efficacy if evaluated in 60 to 90 patients. The study was extended to evaluate 59 additional patients.
3. Executive Summary of Phase 2a Studies
The stage 2 placebo-controlled double blind study was overrun by excessive placebo effect for the two primary end points of efficacy. Excessive placebo effect would not be unusual in many trials for drug candidates with marginal efficacy. Even in such cases, however, the efficacy of the placebo group is hardly more effective than the treatment group with statistical significance (p 1b study with OLP-1002.", said Dr. Shin Chung, CEO of OliPass Corporation. "Although OLP-1002 was found inferior to placebo in this Phase 2a trial, there are still hundreds of reasons to believe that OLP-1002 is the most effective pain killer ever developed. In order to develop OLP-1002, we would need an extremely sensitive detection method for OLP-1002 in plasma to block the loophole of bioanalysis while implementing clinical trials. The exposure to OLP-1002 is hardly traceable for now due to the infinitesimal therapeutic dose level. In this regard, we should be serious about a collaboration early on with a big pharma with strong bioanalysis capability. We are certainly destined to serve people with refractory pain.", added Dr. Chung.
Provided below are the observed clinical findings of excessive placebo effect from the Phase 2a studies as well as the Phase 1b study conducted in the middle of the Covid19 pandemic.
4. WOMAC Pain Findings from Interim Analysis
The 2 mcg group showed a pattern of pain reduction gradually increasing to reach 55% in Day 43. In case of the placebo group, pain reduction reached its maximum of 43% in Day 15 and then gradually decreased to 26% in Day 43. The 1 mcg group showed a pain reduction of 18% in Day 43, and was the least effective among the three groups. The difference in Day 43 was slightly short of significance (p 1b Study
Overt placebo effect has not been unprecedented with OLP-1002. In a Phase 1b study in OA patients conducted in Australia again with Novotech, patients were subcutaneously administered with placebo, 5 mcg OLP-1002 or 10 mcg OLP-1002 two times per week for two weeks, and then subjected to pain assessment for six weeks post the first dose. At the end of the study, i.e., Day 45, the observed pain reduction by WOMAC Pain was 21% for the 5 mcg group (n = 13), 32% for the 10 mcg group (n = 11), and 55% for the placebo group (n = 10). The placebo group was significantly (p -18M) in vitro potency and broadly distributes to tissues, which would be responsible for its very small therapeutic dose and long therapeutic duration. Unlike small molecule inhibitors of Nav1.7, OLP-1002 possesses disease-modifying activity by down-regulating neuropathic hypersensitization. OLP-1002 would be the first Nav1.7 selective inhibitorNav1.7 selective inhibitor manifesting strong efficacy and good safety.
[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 to show good cell permeability and ultra-strong affinity for RNA. 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.
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