Shares in MannKind were trading up nearly 20% yesterday after its inhaled insulin smashed goals in two late-stage studies, pushing it closer to approval.
The US biotech, which is yet to get one of its products to market, said it plans to resubmit an application for Afrezza in the US in the Autumn on the back of data from two Phase III trials in patients with diabetes.
Findings from Study 175 in patients with type II diabetes showed that Afrezza - a fast-acting, mealtime insulin powder delivered via the Dreamboat inhaler - induced superior reductions in A1c levels and helped more people reach their blood sugar targets compared to an oral therapy alone.
The data show that, after 24 weeks of treatment, 37.7% of patients in the Afrezza group achieved A1c levels below 7% compared to only 19% of patients in the comparator oral-therapy group, while 15.9% had levels below 6.5% versus just 4.2% of the control group.
According to Alfred Mann, MannKind's chairman and chief executive, the results indicate that Afrezza can be used "to improve glycaemic control in insulin-naive type II diabetes patients that are not adequately controlled on conventional oral medications – a potentially large and underserved patient population.”
In addition, data from Study 171, in patients with type I diabetes, showed that its drug was non-inferior compared to insulin aspart at reducing levels of A1c, but crucially it was also linked with significantly less hypoglycaemia and a significant weight advantage, the firm said.
"Based on the results of this study , we believe that Afrezza can be used to achieve glycaemic control that is comparable to the current standard of care while at the same time offering potential advantages in terms of lower fasting blood glucose levels, weight neutrality and a lower overall risk of hypoglycaemia," said Mann.
Importantly, a head-to-head comparison of pulmonary safety data for the Dreamboat inhaler and its predecessor, the MedTone inhaler, also threw up no concerns.
Investors will be particularly pleased with the news given Afrezza's rocky road to market thus far; following a rejection by the US Food and Drug Administration in 2010, the agency turned it down again in 2011 requesting more trials, significantly delaying its potential approval.