Pharmaprojects R&D Pipeline News Feed
Breathing new life into inhaled insulin?
11 Jun 2009
Mannkind Corporation has presented new data on its inhaled insulin propect, Afresa, indicating that it may be comparable to the injectable standard of care. Presented at the American Diabetes Association's (ADA) 69th annual Scientific Sessions meeting, Mannkind hopes the results from three Phase III trials in Type I and II diabetics will support the NDA for Afresa, which was accepted by the US FDA in May.
In the first trial in 589 Type I diabetics, Afresa was determined to be non-inferior to Novo Nordisk's Novolog, a rapid-acting insulin analogue, as measured by the change in HbA1C levels. At 52 weeks, these dropped from 8.48 to 8.20 for patients on Afresa, compared with 8.48 to 7.99 for Novolog. In the second trial, which was in 1554 Type II diabetics, Afresa achieved an HbA1C level of less than 7% (the figure recommended by the ADA) in 22% of patients, comparable to the 27% seen for those in the comparator group receiving Sanfofi-Aventis' insulin glargine. The final trial was a two year safety trial in both types of diabetes necessary to address the potential effects on pulmonary function raised by the use of an inhaled therapy. Using one-second FEV1 as the primary measure, no difference was observed between Afresa and those on standard insulin therapy.
Inhaled insulin has long been a goal of the industry due to the obvious inconvenience of self-injection. The first and only inhalable insulin to reach the market was Nektar Therapeutics' Exubra, although this was subsequently withdrawn in the US after failing to meet customer needs or financial expectations. Afresa is leading the rest of the pack as it is currently awaiting approval in the US; beyond this Pharmaprojects lists eight inhaled antidiabetic products ranging from preclinical to Phase II development, of which half are insulin formulations.
