Kipspharma Oral Platform, 40 Times Higher Absorption Rate in Primates Compared to Novo Nordisk's 'Oral Wegovy'

[Financial News]  Kipsbiopharma (hereafter Kipspharma)'s subsidiary Kipsbiomed is developing an oral peptide drug delivery platform 'Oraloid™', which recorded more than 40 times the absolute bioavailability (oral absorption rate) in a non-clinical trial on primates compared to 'Oral Wegovy' (product name Rybelsus), reaffirming its overwhelming technological prowess compared to competitors.
Kipspharma announced on the 14th that it confirmed an average absolute bioavailability of 6.7% (maximum 11.3%) in a non-clinical trial on primates conducted by a global Contract Research Organization (CRO) with an 'oral insulin' capsule applied with the oral platform technology Oraloid.
This figure is more than 40 times superior compared to the 0.16% absolute bioavailability in primates of Novo Nordisk's Rybelsus, the only oral GLP-1 ingredient medicine on the market. Rybelsus, which applies the platform technology called 'SNAC', also showed an absolute bioavailability of only 0.4~1% in human clinical trials.
'Absolute Bioavailability' is an analysis of oral absorption rate compared to intravenous injection (IV), and it has the advantage of allowing a more accurate absorption rate evaluation than 'Relative Bioavailability', which is usually compared with subcutaneous injection (SC). Absolute bioavailability is also an important criterion when entering human clinical trials.
A Kipspharma representative said, “In previous experiments on rodents and beagle dogs, it was repeatedly confirmed that the relative bioavailability was the highest in the world, so in this non-clinical trial on primates, we confirmed the absolute bioavailability for more accurate absorption rate measurement and rapid clinical entry,” adding, “As we confirmed overwhelmingly superior absorption rates compared to oral products on the market by global big pharma with data, we believe the success potential of the Oraloid platform has also increased.”
Previously, the Oraloid platform recorded a relative bioavailability of 35.1% in rodents and an absolute bioavailability of 8.6% and a relative bioavailability of 37.7% in a non-clinical trial on beagle dogs. In this non-clinical trial on primates, the relative bioavailability was not confirmed, but the company explained that clinical utility has already been sufficiently secured.
Hwang Yonghwa, director of Kipsbiomed Research Institute, explained the background of the non-clinical trial, saying, “All oral absorption rate announcements submitted by Novo Nordisk when approving Rybelsus are absolute bioavailability,” and “To ensure successful clinical trials in the future, we have secured more accurate data in various large animal trials, including the absolute and relative bioavailability of beagle dogs and the absolute bioavailability of primates.”
Regarding the reason for applying oral insulin for absorption rate measurement, Director Hwang said, “The molecular weight of insulin reaches 5800 Dalton (Da), and when the molecular weight is this large, it is difficult to be absorbed in the stomach or intestines, and the sensitivity to digestive enzyme degradation inevitably increases,” adding, “The significance is great in that insulin with a large molecular weight is much more difficult to develop compared to GLP-1 (semaglutide) with a relatively smaller molecular weight.” The molecular weight of semaglutide, the main ingredient of Novo Nordisk's obesity treatment Wegovy, is about 4100 Dalton.
As high absorption rates have been confirmed in successive oral insulin animal experiments, positive results are expected in GLP-1 ingredient medicines, which are recently gaining attention as obesity treatments, with the Oraloid platform. Kipsbiomed is currently conducting various non-clinical trials on primates with different doses, aiming for rapid entry into the main clinical trials of oral obesity treatment (GLP-1). The company stated that it is focusing on technology advancement and sufficient data acquisition, keeping in mind future presentations at international conferences related to diabetes and obesity and partnering meetings.
Lee Yongkyu, CEO of Kipsbiomed, said, “We expect to confirm the results of the non-clinical trial of oral GLP-1 in primates soon,” adding, “If world-class absorption rates are proven in GLP-1 following insulin, we are drawing various development roadmaps to enable independent clinical entry or joint development with big pharma as soon as possible.”





kakim@fnnews.com Kim Kyunga Reporter