Ollipass "Occurrence of Special Issue Related to 'Unblinding' in Australian Phase 1b Clinical Trial"

[Asia Economy Reporter Minji Lee] Olipass announced on the 8th that in relation to the ‘blinding unmasking’ of the Australian Phase 1b clinical trial of the non-narcotic analgesic new drug OLP-1002, an unusual situation occurred where the pain assessment scores in the placebo group decreased excessively compared to the analgesic administration group, contrary to expectations.

This clinical trial, conducted primarily to evaluate the safety of the non-narcotic analgesic new drug OLP-1002, was a placebo-controlled double-blind study that also included an exploratory preliminary analgesic efficacy evaluation. It was designed to administer OLP-1002 and placebo five times over two weeks to more than 30 patients with chronic arthritis pain, followed by a six-week evaluation of pain changes using the VAS and WOMAC methods.

Based on the ‘blinding unmasking’ data recently received from the clinical trial’s overseeing CRO, Olipass conducted a provisional statistical analysis of pain data by treatment group. The results showed a significant decrease in pain scores in the placebo group compared to the drug administration group. The company explained that this is a very unusual result considering the characteristics of chronic pain experienced by the patient group.

Youngrae Kim, Vice President of Clinical Development at Olipass, stated, “Among the 10 patients in the placebo group, 5 showed more than a 70% reduction in pain, while 4 showed no pain reduction, resulting in no statistically significant difference in pain reduction between the placebo and treatment groups. Considering that changes in VAS and WOMAC pain scores per patient were generally observed to be similar, the reliability of the evaluation methods appears to be high, indicating that a detailed review of the placebo group patients is necessary.”

Since safety has been confirmed through this clinical trial, Olipass plans to proceed as scheduled with the European Phase 2a trial targeting patients with neuropathic pain and the Phase 2a trial targeting patients with chronic arthritis pain within this year. Additionally, until the final results of this clinical trial are obtained, the company intends to thoroughly analyze the causes to ensure thorough preparation for future clinical protocol establishment.