MannKind Corp. on Friday said that new data indicates its experimental insulin inhaler controls blood sugar levels in diabetics without meaningful, long-term changes in lung function, answering a safety concern of regulators.
The Valencia biotech is awaiting Food and Drug Administration approval of Afrezza, which is designed to deliver more effective rapid-acting insulin than injectable or oral insulin. The FDA last month delayed a decision, saying it needed more safety information on the device before it could complete its review.
Results from two late-stage clinical studies of Afrezza were presented Friday at an American Association of Clinical Endocrinologists meeting in Boston.
MannKind said a two-year study in patients with Type 1 (juvenile) diabetes found that Afrezza provided glucose control similar to standard insulin therapy along with weight loss and reduced incidence of hypoglycemia.
“Our study shows that treatment regimens incorporating Afrezza offer glycemic control comparable to conventional regimens, with the added benefits of weight loss and less incidence of hypoglycemia, making Afrezza a potentially important and useful new treatment option in the diabetes space,” said Dr. Philip Raskin, a Southwestern Medical School-University of Texas clinical investigator on the study.
Another patient study looking at follow-up safety data suggested any changes in lung function associated with the use of Afrezza in patients with Type 1 and Type 2 (adult) diabetes was not likely due to any structural alteration in the lungs, the company said.
“Our findings add to the growing body of clinical evidence that indicates Afrezza is comparable to standard of care insulin therapy in terms of lung safety,” said Peter Richardson, MannKind’s chief scientific officer.
MannKind shares were up 39 cents, or 3.7 percent, to $6.47 in midday trading on the Nasdaq.