According to Dance Biopharm, a 12-patient, randomized, semi-blinded Phase 1/2 pharmacokinetic study of its Adagio inhaled insulin in patients with Type 1 diabetes demonstrated the safety of the product and showed that it did not cause coughing. The Samba 01 study also showed consistent delivery of insulin, comparable to delivery by injection. Adagio is an inhalation solution delivered using an Aerogen portable vibrating mesh nebulizer.
Dance Chairman and CEO John Patton commented, “Hundreds of my colleagues and I spent decades of our lives in the 90s and 00s showing that inhaled insulin is safe, reliable and effective. It is a damn shame that despite US and EU approval, inhaled insulin is still not available, but we learned so much from the first-generation products and now there are two improved second-generation products in development. Dance has carefully selected a delivery system that is small, patient friendly and efficient that addresses issues with the first-generation efforts. With Phase 2 trials under way and active discussions with the EMA and FDA, we believe we are on a clear path to delivering this product to the many patients around the world who are in great need of an alternative to injectable insulin.”
The next study of the product, Samba 02, is a PK/PD study in Type 2 diabetes patients. According to Dance, the initial trial involved Type 1 patients “based on the ability to obtain a more precise measurement due to their lack of endogenous insulin.”
Read the Dance Biopharm press release.
