Delivery via inhaler could dramatically expand Epinephrine’s clinical utility for emergency self-administration to prevent worsening of early symptoms of anaphylaxis
Roden, The Netherlands — August 4th, 2020 — PIMS-E, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for allergic reactions and anaphylaxis, announced the completion of the dosing of 10 subjects in 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 were evaluated and compared with one intramuscular Epi-Pen™ injection.
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 mean 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 to individuals at high risk of anaphylaxis, 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. It was previously demonstrated that sufficient epinephrine can be inhaled during an anaphylactic reaction in order to increase plasma epinephrine concentrations promptly and significantly (i.e. to the same extent as achieved after 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. The dominant epinephrine standard-of-care (SOC) product – the Epi-Pen™ – currently caters to a 1$billion+ market. If authorized, Epinephrine Cyclops™ will provide patients and healthcare payers access to a lower cost, safe and effective generic alternative for currently overpriced epinephrine (SOC) products.
About PIMS-E, PureIMS and Cyclops™
PIMS-E, a subsidiary of PureIMS, has global rights to Epinephrine Cyclops™, a dry powder inhalation device 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. The Cyclops™ DPI is an easy-to-use, pre-filled, disposable DPI that is developed for high-dose drugs and emergency applications. It 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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