Olipass, an RNA therapeutics platform company, revealed that the pain evaluation value of the placebo group unexpectedly decreased excessively compared to the analgesic group in relation to the’unblinding’ of the Australian clinical trial 1b of the new non-narcotic analgesic drug OLP-1002 on the 8th. Announced that this has occurred. However, as safety has been confirmed, the phase 2 clinical trial, which evaluates the efficacy and safety of patients, will be conducted in the second half of this year as scheduled.
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.
It was designed to evaluate the change in pain over 6 weeks by the VAS and WOMAC methods after administering OLP-1002 and placebo 5 times over 2 weeks.
Olipass temporarily statistically processed pain data for each medication group based on the unblind data 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 a very unusual result considering the characteristics of chronic pain experienced by the target patient group.
Dr. 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% of pain reduction was observed in 5 out of 10 people in the placebo group, whereas there was no pain reduction in 4 people in the placebo group. “There was no statistically significant difference in pain reduction between the and administration groups,” he said. “Considering that the changes in VAS and WOMAC pain levels for each patient were generally observed, the reliability of the evaluation method was high, so a detailed review of the patients in the placebo group. “I need it.”
“It is regrettable that 8 patients near painlessness were observed in the Australian clinical trial, but the decrease in pain in the placebo group was observed abnormally large,” he said. “It is struggling with the patient who willingly participated in the clinical trial in the situation of the Corona 19 pandemic. I am very grateful to one of the clinical staff,” he said.
“Basically, phase 1 clinical trial is to verify the tolerability and safety of new drugs, and in the process, we conducted a’preparatory analgesic efficacy evaluation’ for future clinical trials,” said an official from Olipass. Phase 2a clinical trials in Europe for patients with impaired pain and Phase 2a clinical trials for patients with chronic arthritis pain are scheduled to be conducted within the year as planned. I will do it,” he said.