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Argen x nav1.75/3/2023 ![]() OLP-1002 is being evaluated to pin down the therapeutic dose in OA patients which is translated further into the therapeutic dose for peripheral pain in general. "Given that OLP-1002 possesses disease-modifying activity to down-regulate neuropathic hypersensitization, the analgesic efficacy of OLP-1002 shall increase upon repeated dose," added Dr. "The ongoing Phase 2a study has been estimated to be statistically fully powered, once the study is completed in 90 patients as initially planned," said Dr. Taken these interim findings together, 2 mcg is the therapeutic dose eliciting strong efficacy with an injection frequency of once every two months. VAS scores showed a similar trend to WOMAC Pain scores. The current sample size (10 patients per group) of this interim analysis would be too small for OA pain trials to draw reliable conclusions by statistical analysis. The difference was either slightly short of significance (p-value 0.07 by t-test) or significant (p-value 0.011 by Wilcoxon test). The observed difference between 2 mcg OLP-1002 and placebo in day 43 is regarded quite large compared to conventional pain killer's efficacies in OA pain studies. Consequently, 2 mcg group and placebo started differentiating from day 22 (3 weeks) post dose. In the meantime, placebo effect peaked in day 15 (2 weeks) post dose and then gradually subsided to a decrease of 26% from the baseline in day 43. The observed % decrease in day 43 was 55% from the baseline. The average WOMAC Pain score of 2 mcg group gradually decreased and reached the lowest in day 43 (6 weeks) post dose. An interim analysis was carried out for the first 30 patients (10 patients per group) completed the pain assessment primarily by WOMAC Pain and VAS. In the Phase 2a study designed to evaluate 90 osteoarthritis (OA) patients in total, patients are subjected to pain assessment for 6 weeks following a single subcutaneous injection of 1 microgram (mcg) OLP-1002, 2 mcg OLP-1002 or placebo (vehicle only). SEOUL, South Korea, Ma/PRNewswire/ - OliPass Corporation, an RNA therapeutics platform company, disclosed that OLP-1002, a selective inhibitor of Nav1.7 sodium ion channel, showed strong analgesic efficacy and long therapeutic duration according to interim findings from a placebo-controlled double blind multicenter Phase 2a study in chronic osteoarthritis patients with moderate to severe pain in Australia.
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