Nasulin™

Bentley’s permeation technology has been validated with Testim for small molecules and dermal applications and the Company has been working to extend the technology to more complex molecules – especially therapeutic peptides for treatment of chronic diseases. The first therapeutic target in this area is insulin, and there is potential for non-injectable forms of insulin to reshape the 8 billion dollar market for diabetes. Nasulin is Bentley’s patented intranasal insulin spray incorporating CPE-215 as a permeation facilitator that addresses the need for an improved delivery method for insulin.

Diabetic patients are generally dissatisfied with currently available injectable insulin treatments. As a result, poor compliance and under treatment can cause serious diabetic complications. Nasulin is specifically designed to facilitate compliance and avoid long-term consequences brought on by inconsistent treatments.

In general, drugs entering the nasal cavity are readily absorbed across the highly vascularized nasal mucosa directly into the circulatory system avoiding first-pass metabolism in the liver. The speed of absorption affords a fast onset of action comparable to the very rapid-acting, injectable insulin formulations. With the benefit of Bentley’s CPE-215 drug delivery platform technology, initial studies have indicated that Nasulin passes quickly through the nasal mucosa, delivering a larger payload compared to other non-injectable delivery systems. In addition, Nasulin provides a non-invasive nasal administration in a commercially available multi-dose delivery device, which is convenient to carry and discreet to use. Nasulin is stable under refrigerated conditions for 2 years and stable at room temperature for 1 month or more.

Global Phase II trials are now under way for Nasulin. Two earlier studies conducted in Ireland with normal subjects and Type I diabetic patients demonstrated rapid absorption from the nasal spray with the expected glucose response.