[약업신문]Olipass, Australia’s Phase 1b placebo group has a huge gap in pain reduction

On the 8th, OLP-1002, a new non-narcotic analgesic drug, was unblinded in the Australian clinical trial phase 1b. It was announced that there was a specific issue, such as a decrease.

This’placebo-controlled double-blind’ clinical trial, which aimed at evaluating the safety of OLP-1002, a new non-narcotic analgesic drug, in more than 30 patients with chronic arthritis pain, conducted a preliminary analgesic efficacy evaluation for exploratory purposes. After administration of OLP-1002 and placebo 5 times over 2 weeks, it was designed to evaluate the change in pain over 6 weeks by VAS and WOMAC methods.

Olipass temporarily statistically processed pain data for each medication group based on the’unblinded’ data recently received from the CRO in charge of the clinical trial. As a result, a significant reduction in pain levels was observed in the placebo group compared to the drug-treated group. This is explained as a very unusual result considering the characteristics of chronic pain experienced by the target patient group.

Young-rae Kim, vice president of clinical development for Olipass, a specialist in pain and rheumatology, said, “It will be clear when the final results of this clinical trial are analyzed, but more than 70% pain reduction was observed in 5 out of 10 placebo patients, whereas there was no pain reduction in 4 patients. “The difference in pain reduction between the placebo group and the treatment group was not statistically significant.” It needs to be reviewed.”

“We had high expectations because eight patients near painlessness were observed in the Australian clinical trial, but it is unfortunate that the pain reduction in the placebo group was observed abnormally large.” “We struggled with patients who were willing to participate in the clinical trial in a corona pandemic situation. I would like to express my great appreciation to one of the clinical staff.”

As the safety was confirmed through this clinical trial, Olipass said that the European phase 2a trial for neurologically damaging pain patients and the phase 2a clinical trial for chronic arthritis pain patients will proceed within this year as scheduled. In addition, the company plans to thoroughly analyze the cause until the final result of this clinical trial is drawn, and make every effort to establish a clinical protocol in the future.