MannKind Announces Completion of Cohort 1 and Opens Enrollment for Cohort 2 of Afrezza® Safety and Pharmacokinetics Study in Pediatric Patients
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,
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
For additional information about the study, please contact
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.
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