Delivery via single-inhaler could dramatically expand epinephrine’s clinical utility for emergency self-administration to prevent worsening of early symptoms of anaphylaxis
Roden, The Netherlands — October 29th, 2020 — PIMS-E announces the results of a randomized, placebo-controlled phase 1 clinical trial to evaluate inhaled epinephrine in healthy volunteers.
The main goal of this trial was to evaluate the (pulmonary) safety, tolerability and pharmacokinetics of escalating doses of inhaled epinephrine in healthy subjects. Three inhaled, escalating single-doses (0.35, 0.65 and 1.3 mg) were evaluated and compared with one intramuscular Epi-Pen™ injection (0.3 mg). Epinephrine Cyclops™ was well tolerated and no serious adverse reactions were reported. Furthermore, theoretically effective peak plasma concentrations were measured within five minutes after inhalation which supports the idea of a fast relief remedy to stop the “mast cell – leucocyte cytokine cascade”, which otherwise may result in fainting, shock, and even death.
The inhaled epinephrine development program is substantially funded with federal funds from a public-private partnership (PPP) allowance by the Top Consortium Knowledge & Innovation (TKI) of the Sector Life Sciences & Health (LSH), part of the Dutch Ministry of Economic Affairs and Climate Policy.
“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”, said Reinier Schwietert, CEO of PIMS-E.
About Epinephrine Cyclops™ and Anaphylaxis
Epinephrine Cyclops™ (epinephrine dry powder for inhalation) is a non-invasive, user-friendly alternative or substitute for an epinephrine injection. Although the incidence of anaphylaxis is relatively low, recent data suggest that episodes of anaphylaxis, particularly those triggered by food or drugs, are increasing thus promising an attractive market for Epinephrine Cyclops™.
About PIMS-E, PureIMS and Cyclops™
PIMS-E, a subsidiary of PureIMS, has global rights to Epinephrine Cyclops™, an epinephrine-pre-filled dry powder inhaler for intervention in allergic reactions and anaphylaxis. PureIMS is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of respiratory and systemic diseases with significant unmet medical needs. Cyclops™ is an easy-to-use, pre-filled, disposable dry powder inhaler that has been developed for high-dose drugs and emergency applications. This patent-protected inhaler is cheap to produce because of its simple yet sophisticated design. Upon inhalation it uses the patient’s breath to circulate and disperse the dry powder formulation into small particles appropriately sized for inhalation. Cyclops™ has several advantages compared to standard-of-care products across key therapeutic areas. These attributes enable the hygienic and effective use on a worldwide scale.
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