Just as a whole host of drugmakers have abandoned inhaled insulin, the USA’s MannKind Corp has presented some promising late-stage data which suggests that Afresa is as safe and effective as injection therapy.
MannKind it has met the primary endpoints of its final two of three Phase III studies of Afresa, an ultra-rapid-acting, inhaled insulin product. The company did not disclose much detail about the trials, limiting itself to saying that the first (study 030) compared the pulmonary safety of meal-time inhalation of Afresa versus usual care in over 2,000 patients with type 1 and type 2 diabetes. After two years of treatment, no adverse effects were observed on patients’ lungs in the Afresa-treated group.
The second study (102) compared the efficacy of meal-time Afresa in combination with a long-acting basal insulin versus twice daily injections of pre-mixed insulin. The data revealed comparable improvements in HbA1c levels over 52 weeks between the two treatment groups.
Peter Richardson, MannKind’s chief scientific officer, confirmed that the more complete data, including analyses of secondary endpoints, are expected before the end of this year. He added that “our next step is to finalize a New Drug Application for Afresa (formerly known as Technosphere Insulin) which we expect to submit to the Food and Drug Administration in early 2009″.
MannKind’s news comes in the wake of Eli Lilly (AIR) and Novo Nordisk (AERx) pulling their inhaled insulin programmes, while Pfizer withdrew Exubera last year from the US market due to weak demand. In April this year, the New York-based giant issuing a warning concerning possible cancer risks linked to the latter inhaled insulin drug.
Analysts were not overly-enthusiastic about the prospects for Afresa. Cory Kasimov at JPMorgan issued a research note saying that he was maintaining a more cautious view “given our general lack of confidence in the murky regulatory environment, and more importantly, our belief that investors will remain sceptical about the daunting commercial marketplace thanks to the Exubera experience”.
