January 10, 2022 (COPENHAGEN, Denmark). The Danish drug development company, Zerion Pharma A/S (ZERION) has completed a new animal study (in dogs) that clearly demonstrates the potential of its patented Dispersome® technology for reducing the amount of drug in tablet formulations. The Dispersome® technology is a leading drug solubility enhancing technology for tablet formulations, resulting in improved bioavailability. ZERION believes that this technology can be applied to a major part of all new oral drugs in development as well as many marketed drug products that suffer from low solubility and as a result low bioavailability. Low solubility is one of the biggest challenges in drug development and the Dispersome® technology provides an innovative solution.
ZERION’s lead program ZN002 is aimed at improving the formulation of a currently marketed cancer treatment by obtaining bioequivalence to the originator product but with a substantial reduction in the amount of active drug, and consequently number of tablets per administration. In the animal study, where ZERION tested Dispersome® tablet formulations against a marketed reference tablet formulation, it was shown that the amount of active drug could be reduced by 75% while maintaining the same plasma concentration as the originator product. This corresponds to 4 times increase in bioavailability.
“These are remarkable results that prove that the drug solubility increase provided by our Dispersome® technology translates into significant improvements in bioavailability. This is not the first time we have demonstrated this critical link, but these results are the most convincing to date and exceeded our expectations”, says Dr. Korbinian Löbmann, Chief Scientific Officer in ZERION.: “We are now further optimizing our formulations to select the most promising Dispersome® tablet formulation in a follow up animal study. Our goal is to confirm the results in a human bioequivalence study as soon as possible during 2022.”
The study results are positive news for the patients, according to Ole Wiborg, ZERION’s CEO:
“More than anything, this is good news for the millions of patients that struggle with having to take a large number of tablets every day. Many elderly patients suffering from cancer and/or chronic diseases need to take several different medications. This can run up to dozens of tablets daily and in addition to the logistical nightmare, difficulties in swallowing the tablets makes this a real burden for many patients, says Ole Wiborg. “We cannot solve all the challenges associated with complex medications, but we are convinced that the reduction in the amount of active drug ingredient and the number of tablets enabled by our Dispersome® technology is an important step on the way.”
On a global scale, cancer patients are annually taking more than 100 million tablets containing the originator drug that is improved in ZERION’s ZN002 program. The study results indicate that, everything else equal, this could potentially be reduced to as little as 25 million tablets with a new Dispersome® product that is patent protected.
In addition to the benefits to the patients, there will be significant positive environment impact. Cancer drugs are most often very toxic and can be poorly degradable in the environment. The reduction in amount of active drug will therefore result in a lower environmental burden both at the site of manufacture as well as in wastewater, since less unabsorbed drug will be excreted from the patients. In addition, the Dispersome® technology is based on using beta-lactoglobulin, which is produced from a sustainable source of whey protein, a by-product from cheese production.
ZERION has pioneered the Dispersome® technology that greatly enhances the solubility of poorly soluble, oral drugs and improves bioavailability and the therapeutic options for patients. The Dispersome® technology is based on preparing stable amorphous formulations by mixing high loads of the drug compound with beta-lactoglobulin. ZERION develops proprietary drug formulations and offers the Dispersome® technology to established pharma companies as a means to solve their most challenging drug solubility problems. The Dispersome® technology is patent protected and offers in connection with any pharmaceutical drug many additional years of IP protection.
ZERION was established in 2019 as a spinout from the University of Copenhagen based on almost a decade of research. (Dispersome® is a trademark of Zerion Pharma A/S)
For more information, please visit www.zerion.eu or contact:
Ole Wiborg, CEO Mobile: +45 40 96 80 18
