PureIMS subsidiary PIMS-E has announced that a Phase 1 clinical trial of its epinephrine DPI demonstrated that the dry powder epinephrine was well tolerated with no serious adverse reactions and produced peak plasma concentrations at levels that should be effective within 5 minutes post inhalation. PIMS-E is developing the epinephrine inhaler for the treatment of anaphylaxis.
The SAD trial evaluated 0.35, 0.65, and 1.3 mg doses of the dry powder epinephrine delivered via the PureIMS Cyclops inhaler compared to a 0.3 mg EpiPen dose. PureIMS is developing a number of candidates using the preloaded, disposable Cyclops inhaler, including amikacin, which is in Phase 1 development for the treatment of tuberculosis, levodopa, colistin, and tobramycin.
PIMS-E CEO Reinier Schwietert said, “We appreciate the financial support from the federal government for the development of Epinephrine Cyclops, which would offer a significant contribution to the well-being and quality of life of patients at risk of anaphylaxis. Data from this trial and potential future studies could support the inclusion of Epinephrine Cyclops in national and international guidelines that promote the rational prescribing of epinephrine for emergency self-administration in order to prevent worsening of early symptoms of anaphylaxis.”
Read the PIMS-E press release.
