MannKind receives Breakthrough T1D grant for pediatric Afrezza trial

MannKind Corporation (Nasdaq: MNKD) has received a grant from Breakthrough T1D, formerly known as JDRF, to support its INHALE-1ST clinical trial evaluating inhaled insulin Afrezza in pediatric patients newly diagnosed with type 1 diabetes.

The grant was awarded through Breakthrough T1D's Industry Discovery and Development Partnership program. The INHALE-1ST study is a single-arm, multi-center trial assessing the safety and efficacy of Afrezza in combination with once-daily subcutaneously injected basal insulin in patients aged 10 to under 18 years who have been recently diagnosed with type 1 diabetes.

The trial's primary endpoint is the percentage of participants achieving a continuous glucose monitor time-in-range of 70–180 mg/dL at or above 70% during the 14 days prior to the 13-week visit. The main phase runs 13 weeks, followed by an optional 26-week extension phase.

MannKind said it recently completed enrollment of the pilot phase of the INHALE-1ST trial. The FDA approved Afrezza for use in pediatric patients aged 6 and older in May 2026, expanding on its original 2014 approval for adults.

"This collaboration with Breakthrough T1D represents meaningful external support of both Afrezza's potential role in transforming insulin therapy and of the INHALE-1ST trial," said Michael Castagna, Chief Executive Officer of MannKind.

Jonathan Rosen, Breakthrough T1D Director of Research, said the organization's priority is advancing therapies that can reduce the daily burden of living with type 1 diabetes, adding that the trial will assess Afrezza's impact in the new-onset pediatric population.

According to the press release, more than 350,000 children and adolescents in the United States are living with diabetes, the majority with type 1 diabetes requiring lifelong insulin therapy.

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