Rapid-acting insulin specialist MannKind Corp. (NSDQ:MNKD) has enrolled the first pediatric patient in its INHALE-1 study evaluating its Afrezza (Technosphere Insulin) with basal insulin versus multiple daily injections of insulin. The study will enroll participants aged four to 17 with type 1 or type 2 diabetes.
Afrezza first won FDA approval in 2014, and MannKind initially partnered with Sanofi (NSDQ:SNY) to market the drug. Sanofi pulled out of the partnership in 2016.
The INHALE-1 is a 26-week open-label, randomized study with a 26-week extension.
The primary endpoint of the study will be the average HbA1c level after 26 weeks. Secondary endpoints include changes in fasting plasma glucose and the rate of hypoglycemic events at the same interval.
Earlier this year, MannKind CEO Michael Castagna said that the company has focused on increasing the number of presentations and publications related to Afrezza to boost its sales.
MNKD shares, which were briefly trading above $100 apiece in 2004, have fallen considerably since then. They closed at $4.50 today.
In 2017, it entered a deal with a group of unnamed investors for a registered direct offering worth $61 million.
In September, it announced that it had entered into a sale-leaseback transaction that it expects to generate $102.25 million in gross proceeds.