MannKind says phase 2b studies of Technosphere inhaled insulin yield promising results

By E. Janene Geiss

Philadelphia, Jan. 17 - MannKind Corp. said Tuesday that results from a phase 2b dose-ranging study of Technosphere insulin, an inhaled insulin formulation delivered via the company's proprietary inhaler, showed improved glycemic control in diabetes patients.

Technosphere insulin was observed to improve glycemic control in a dose-dependent manner as measured by decreases in HbA1c levels (a measure of the average amount of blood sugar over the preceding three to four months) and in glucose excursions following a meal, according to a company news release.

Importantly, there was no indication of a negative effect on pulmonary function and no weight gain at any dose of Technosphere over 12 weeks of treatment, officials said.

"The reduction in post-prandial glucose excursions is becoming of much greater interest due to the finding that these excursions may be involved in the pathogenesis of diabetic vascular disease. This study clearly showed that Technosphere insulin produced the desired effect on glycemic control," Irl Hirsch, an internationally-recognized expert on diabetes, said in the release.

The phase 2b dose-ranging study was designed to evaluate the effect of different mealtime doses of Technosphere added to a single, fixed daily injection of basal insulin glargine (Lantus) in patients with type 2 diabetes.

In total, 227 patients were followed on their existing therapy for four weeks, then transferred to insulin glargine and subsequently randomized to receive, in a double-blind fashion, either inhaled placebo (consisting of Technosphere particles only) or Technosphere insulin at dosages of 14, 28, 42 and 56 units, officials said.

Patients who received Technosphere insulin were force-titrated to their preassigned dose and remained on that dose for the duration of the study. HbA1c levels and post-prandial glucose excursions were assessed at the initial visit, at the start of randomized treatment and at the end of the study.

Comparisons were made between the groups receiving Technosphere insulin and the group receiving placebo. Pulmonary safety was assessed by serial measurements of lung function, including forced expiratory volume and carbon monoxide lung-diffusing capacity, officials said.

The study demonstrated that the addition of Technosphere insulin to insulin glargine produced a statistically significant, dose-dependent reduction in HbA1c levels and in post-prandial glucose excursions, officials said.

In patients treated for eight weeks at 56 units, the mean reduction in percent HbA1c levels was 0.79 below that observed in the placebo group, officials said.

Also, at 56 units, the maximal post-prandial glucose excursion was reduced to only 34 mg, a 63% reduction compared to the placebo group.

No reduction of pulmonary function was observed over 12 weeks, officials said, and no change in weight was observed at any dose in the group receiving Technosphere insulin. No severe hypoglycemic episodes were seen throughout the study.

"This study met its primary objective and further supports the Technosphere insulin dosing regimen currently being evaluated in our phase 3 trials. The results are consistent with the company's previous studies on Technosphere insulin," Peter Richardson, chief scientific officer of MannKind, said in the release.

MannKind, based in Valencia, Calif., focuses on development and commercialization of therapeutic products for diseases such as diabetes and cancer.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.