You are here
MannKind Announces Completion of Cohort 1 and Opens Enrollment for Cohort 2 of Afrezza® Safety and Pharmacokinetics Study in Pediatric Patients
WESTLAKE VILLAGE, Calif., Sept. 24, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) announced today that Cohort 2 of the Afrezza® safety and pharmacokinetics study in pediatric patients is now open for enrollment.
The first group of individuals participating in the ongoing pediatric study of Afrezza, which included adolescents with type 1 diabetes aged 13-17 years old, was recently completed. The study findings to date support that the single‑dose pharmacokinetic (PK) profile of insulin levels for this age group is consistent with patterns seen in adult patients. In addition, dosing over a one‑month period demonstrated a safety profile consistent with that observed in adults. As a result of these findings, MannKind and the study investigators are proceeding with enrollment of the second cohort of subjects.
The second cohort will study Afrezza in children aged 8-12 years and will assess PK, as well as the short-term safety and tolerability of multiple doses of Afrezza.
“We are pleased to open enrollment for the next group of children and progress to the next phase of this study,” said David Kendall, M.D., Chief Medical Officer of MannKind. “As is well known, type 1 diabetes is often diagnosed in children and adolescents, and these individuals will continue to require insulin therapy throughout their lives. Evaluating the potential use of Afrezza in children and adolescents as quickly as possible is a top priority for MannKind.”
For additional information about the study, please contact John Krueger, Vice President, Clinical Development, MannKind Corporation at (317) 967‑0794 or email@example.com.
Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.
About MannKind Corporation
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
This press release contains forward-looking statements that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties detailed in MannKind's filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2017. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
SVP, Investor Relations