Ollipass Fails to Secure Efficacy in Interim Results of Painkiller Phase 2a Clinical Trial

[Asia Economy Reporter Myunghwan Lee] OligoPulse, an RNA therapeutic platform company, announced on the 30th that the non-opioid analgesic new drug 'OLP-1002' failed to achieve statistical significance in the interim analysis of the ongoing Phase 2a clinical trial in Australia. However, the company described the results as "encouraging" and plans to continue the trial until completion.

This interim evaluation is based on the first 30 patients who completed the assessment out of a total of 90 participants in the ongoing clinical trial. OligoPulse designed the trial by dividing 90 patients with chronic arthritis pain into three groups: experimental groups receiving 1㎍ and 2㎍ doses of OLP-1002, and a placebo group. The analgesic efficacy for each patient was tracked over six weeks using a placebo-controlled double-blind method. The interim results pertain to the initial 10 patients in each group, totaling 30 patients.

According to OligoPulse's internal analysis, the 2㎍ dose group showed higher analgesic effects compared to the 1㎍ dose group and the placebo group. However, statistical significance was not achieved in the primary pain assessment endpoints.

Statistical significance, commonly represented by the 'P-value,' refers to the probability that the observed difference in efficacy between the treatment and control groups is due to chance rather than a true effect. Typically, a P-value threshold of 5% (0.05) is set; if the P-value is greater than 5%, it is difficult to confirm whether the drug's effect is genuine or a coincidental finding. Therefore, a P-value less than 5% is required to provide evidence of the drug's efficacy. In this interim analysis, OLP-1002 failed to demonstrate scientifically valid evidence of its effect.

OligoPulse stated that, for most analgesics, achieving statistical significance beyond placebo effects in chronic pain clinical trials generally requires evaluation of more than 100 to 200 patients per treatment group. Accordingly, the company plans to complete the clinical evaluation of all 90 patients as originally planned to enhance statistical significance. Through this, they aim to secure a sufficient level of statistical significance.