Olix (226950), an innovative new drug based on RNA interference technology, announced interim data for OLX702A, which is undergoing phase 1 clinical trials in Australia, on the 4th.
The company said, “We are predicting positive clinical results in the future by confirming better-than-expected results in interim data from the Australian phase 1 clinical trial of OLX702A.”
Olix is conducting a phase 1 clinical trial in Australia aimed at confirming the safety and maximum tolerated dose (MTD) of OLX702A.
In phase 1 clinical trials, it is common to check the safety of a drug on healthy volunteers (HV), but last May, the clinical trial plan was changed to add patients with NAFLD (non-alcoholic fatty liver disease) as subjects.
Ollix stated that this was to ensure the safety and tolerability of OLX702A in the human body of NAFLD patients related to the MASH indication, and further confirm the preliminary efficacy of the drug.
According to Olix, currently, administration has been completed for about 60 subjects across the SAD (single escalating dose) and MAD (multiple escalating dose) cohorts, and after 84 days of follow-up after administration, EoS (End of Study) Interim data that has been completed until inspection was confirmed.
In this clinical trial, which was conducted in a randomized and double-blind manner, in the administration group of healthy volunteers with a BMI of 27 or more, the average abdominal circumference, which is an indicator of the degree of visceral fat accumulation, was about 1 in the situation where no guidelines for diet or exercise were given. Data showing a decrease of approximately inches (2.5 cm) were confirmed (p=0.057, n=12).
One subject who showed the greatest reduction had a decrease in BMI of -6.62% and abdominal circumference of -15.3% after about 3 months of administration.
The current analysis is an average figure including the placebo group, and a higher decrease is expected if only the actual drug administration group is analyzed in the future.
Ollix CEO Lee Dong-gi said, “This is interpreted as a result showing that qualitatively excellent weight loss can be expected through reduction of body fat through OLX702A, as the abdominal circumference reduction effect confirmed in the primate test has also been confirmed in humans. In many subjects, placebo He explained, “Data at a level that greatly exceeds the possible effectiveness has been confirmed.”
CEO Lee Dong-gi said, “We plan to confirm the exact results through detailed analysis studies in the future, but the data is at a level that confirms the trend of drug effectiveness even considering the ratio of drug administration group to placebo group of 3:1.”
The SAD cohort targeting NAFLD patients was designed to measure liver fat content, which is one of the direct indicators of MASH. During the follow-up period after administration, one subject confirmed that liver fat content decreased by up to about 70%.
In particular, in some patients, liver fat content decreased to the normal level of 5% or less (3.4%, 3.9%) within 1-2 months after administration.
CEO Lee said, “Based on the pattern of reduction in liver fat over time after a single dose, it was confirmed that the effect can be maintained and the administration interval for at least 3 months is possible. If left untreated, fatty liver can worsen into steatohepatitis (MASH) and is highly likely to progress to liver cirrhosis, liver fibrosis, and liver cancer. “This interim data suggests the excellent efficacy of OLX702A in improving MASH, and based on this, we have a very positive outlook on the future value of OLX702A as a new drug.”
Regarding safety, which is the primary indicator of this phase 1 clinical trial, the adverse reactions observed in the 60 subjects who have completed the medication to date were mild and did not affect patient tolerance, such as increasing the dose or repeat administration of the drug.
Additionally, no serious adverse events (SAEs) were observed.
CEO Lee said, “I consider it a very encouraging result that such excellent preliminary efficacy results were observed in phase 1 clinical trials, which mainly evaluate safety. “We believe that these preliminary effectiveness results will be of great help in quickly completing the technology transfer currently in progress.”
Previously, Olix announced that technology transfer discussions for its MASH and obesity treatment drug OLX702A with multiple global big pharma companies were underway.
Although the specific level of discussion cannot be disclosed as it is a matter of public reporting, and the specific timing cannot be guaranteed as it is a contract with a partner company, the company said that it is conducting follow-up discussions, including discussions on detailed conditions, with the goal of concluding a contract within the year.
Deputy Director Jaejun Yang [email protected]
