Press Release 27 February 2023

Brisbane, Australia 27 February 2023

De Motu Cordis reports progress on the development of its dry powder inhaler (DPI) containing epinephrine (adrenaline) for inhaled anaphylaxis treatment.

After a successful presentation of the project at JP Morgan in January 2023, De Motu Cordis (DMC) is reporting progress on its first product, DMC-IH1, currently in Phase 1 clinical development.

  • In Phase 1 clinical studies testing inhalation delivery of DMC’s proprietary epinephrine formulation, plasma epinephrine concentrations reached Cmax 8 times faster compared to a widely used autoinjector.

  • FDA has indicated that the 505(b)(2) regulatory pathway is applicable for the DMC-IH1 drug- device combination product for anaphylaxis.

Emergency treatment of anaphylaxis and severe allergic reactions is an underserved and rapidly growing medical need, with a projected market size of $6B by 2025. Adrenaline is the only proven treatment for anaphylaxis and the only available treatments are needle-based autoinjectors. This technology has many flaws, not least, storage, administration failures and needle phobia and yet it has been dominant for 30 years. Now this dominance is being challenged by the advent of a new therapeutic option capable of delivering the same efficacy less invasively and more rapidly.

DMC-IH1 is an emergency specific proprietary dry powder inhaler containing epinephrine (adrenaline) for inhaled anaphylaxis treatment, as an alternative to intramuscular delivery via epinephrine autoinjector. Oral inhalation and the subsequent route of administration through the lungs is the most rapid means of epinephrine delivery in a community setting. This method achieves faster peak absorption compared to the other routes of administration intranasal, transdermal and transmucosal. 40 to 60% of anaphylaxis sufferers also suffer from Asthma, inhalers will be familiar to many of them. DMC expects to complete proof of concept and pivotal clinical trials by 2024.

The dry powder inhaler form enables longer product lifecycle, storage and handling across a much broader temperature range and geographies. Worldwide rights to this transformative technology including the platform technology, device and epinephrine formulations are exclusively held by DMC.

Our drug-device combination has the potential to become the basis for a new platform technology as it lends itself to many emergency medicine sectors beyond anaphylaxis.

About DMC

DMC was founded in Brisbane, Australia by Professor John Fraser, an Intensivist and groundbreaking clinician, researcher and company founder. John is also founder of the Critical Care Research Group and is a co-founder of BIVACOR. John co-founded the COVID-19 Critical Care Consortium that facilitated collecting over 35 million data points from ICU units worldwide and aided in the development of treatment pathways.

Since inception, DMC has raised over US $21m in Seed rounds in Australia. All funding to date has been secured via Queensland Business Development Fund, HNW and Australian Family Offices. We propose to undertake a Series A capital raise in 2H 2023.

This press release contains forward-looking statements, which are based on our current expectations and beliefs. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in such statements.

Peter O’Neill
Chief Executive Officer
De Motu Cordis Pty Ltd

P +61 417 787 274
E [email protected]

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