Uppsala 6th Sep 2017

 

Important results from animal studies with PharmaShell® as parenteral depot preparation

 

During the current quarter, Nanexa has conducted a comprehensive animal study aimed at demonstrating the potential for using PharmaShell® in a parenteral depot preparation.

Nanexa has now obtained results from a PK study* in rats where multiple doses of a drug substance coated with PharmaShell® of different shell thicknesses were compared with substance without PharmaShell®. The study was conducted at Charles River Laboratory’s plant in Scotland. It lasted for three weeks, which is significantly longer than the previous PharmaShell® study that lasted six days.

The results from the measurements of the substance in blood plasma showed that the levels after initial higher concentrations rapidly decreased to a constant level, maintained throughout the remainder of the study without tendency to declination. From this we can conclude that the depot function lasts longer than the three weeks we followed the rats in this study. In addition, the results showed that plasma levels were dependent on both dose and shell thickness, giving us important tools for designing drug depots based on specific medical needs. The work on the next animal study is underway with the aim of being able to follow how long the depots continue to be active.

 

The company’s CEO David Westberg comments:

The result presented above are very valuable to the company. When developing a depot preparation, there is sought to achieve optimal treatment effect by having a constant plasma level of drug substance. The development work with the PharmaShell® platform, which is taken place at the company’s laboratory in Uppsala, has now created the opportunities needed to further advance the technology into the development of a future commercial pharmaceutical product. It is obviously very pleasing and important for the development of the company.

The documentation of the company’s PharmaShell® platform was further strengthened by the study as we found out that PharmaShell® did not affect the tissue where the depot was placed, which is also a very important parameter in the production of a commercial product.

Overall, I would like to emphasize that we have taken a big step forward in the development of PharmaShell® and that we approach a very exciting phase in the company’s development.

* A pharmacokinetic study (PK study) is a study on how a drug substance is affected when administered to a living organism. In a pharmacokinetic study, the drug substance is usually monitored by taking blood samples from the organism at several times in order to measure the concentration of drug substance over time.

 

For further information:

Nanexa AB (publ)

David Westberg, VD

Phone: +46 709 42 83 03

E mail: david.westberg@nanexa.se

www.nanexa.com

 

About Nanexa AB (publ)

Nanexa AB is a nanotechnology drug delivery company focusing on the development of PharmaShell®, which is a new and groundbreaking drug delivery system that is expected to have great potential in a number of medical indications. Within the framework of PharmaShell®, Nanexa has partnership agreements with among others, AstraZeneca.