A liquid formulation delivered via a soft-mist inhaler has shown an increase in insulin exposure and a rapid onset of action, according to data from recently completed phase 2 studies.
The soft-mist inhaler developed by Aerami Therapeutics for its inhaled insulin product product AER-501 (formerly Dance-501) is “unique” compared with other ways of delivering insulin through inhalation, Melissa Rhodes, PhD, chief development officer of Aerami Therapeutics (the new name for Dance Biopharm), told MD+DI. “It is special technology powered by a mesh that vibrates 128,000 times per second to aerosolize the liquid,” she said. The design of the inhaler itself also allows the aerosol flow to be laminar, instead of turbulent, so more particles are delivered to the lungs rather than to the back of the throat, she said.
Such a design results in a “record-breaking amount of material delivered to the deep lung,” she said. “A lot of inhalers get about 30 to 40% of a formulation to the lung, but our device gets closer to 80%.”
Using the inhaler may also be a “pleasant experience” when compared with other means of insulin delivery. “There is no needle,” Rhodes said, and “there is no coughing” associated with inhalation, as the inhaler delivers a “very gentle mist,” she said.
The inhaler also utilizes “smart technology” that senses whether patient inhalation is optimal for insulin delivery. It sends light signals to the patient as they are breathing in—a constant green light indicates optimal breathing, and the light flashes quickly or slowly if breathing is too fast or too slow, she said.
The soft-mist inhaler for AER-501 (formerly Dance-501) insulin is ready for phase 3 trials in the United States, Europe, and China, Rhodes reported. The company is looking for strategic partners for the phase 3 program. Phase 2 data were shared at the 55th annual meeting of the European Association for the Study of Diabetes.
Rhodes is hopeful Aerami’s technology can make an impact in patients’ lives. “Fifty percent of diabetes patients have uncontrolled [disease], so we are providing them a noninvasive option to get their levels stable.”