Brisbane, QLD – 16 August 2024 – De Motu Cordis (DMC) is pleased to acknowledge and enthusiastically commends the recent U.S. FDA approval of ARS Pharma's Neffy®, the first-ever needle-free intranasal epinephrine delivery device for the treatment of anaphylaxis. This groundbreaking approval, announced on August 9, represents a significant step forward in expanding emergency treatment options for patients at risk of severe allergic reactions.
DMC views this approval as a pivotal confirmation of the applicability of the 505(b)(2) regulatory pathway for anaphylaxis treatments. This pathway is especially critical for emergency indications like anaphylaxis, where extensive Phase 3 clinical studies may not be feasible. This development not only strengthens our commitment to advancing our own clinical program, which is designed to realise the potential for more rapid epinephrine absorption through inhalation (IH) administration, but also underscores the importance of providing more patient-friendly alternatives.
"We are pleased to see the approval of a needle-free treatment alternative," said Professor John Fraser, Founder, CMO, Director at DMC. "The approval of Neffy® strengthens the motivation for DMC and the broader drug delivery community to continue pushing the boundaries of innovation. We believe that faster epinephrine absorption via inhalation may prove to be a valuable alternative delivery mode not only for anaphylaxis but also for other emergency medical treatments."
As we continue our development work, the approval of Neffy® enhances our commitment to providing cutting-edge solutions to improve patient care and safety in critical situations.
"We expect further growth in approvals of improved treatments for anaphylaxis indications over the next 3 to 5 years, primarily driven by continuing innovation in and approvals of improved delivery technologies," said Peter O'Neill, Chief Executive Officer, DMC. "With these advancements, we expect the addressable patient market to expand by a factor of 2 to 3. Currently, in the U.S. alone, only 8% of individuals with type 1 severe allergic reactions have an active auto-injector prescription, highlighting a significant unmet need."
DMC is actively developing DMC-IH1, a proprietary drug-device inhaler platform technology specifically designed for emergency medicine in community settings. This platform is being tailored to be easily used by non-medically trained patients and caregivers, providing a more accessible and effective treatment option, particularly in situations where a rapid response is critical.
About DMC
"DMC is a clinical stage pharma company". 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 Pty Ltd. 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 primarily in Australia. The majority of funding to date have been secured via the Queensland Business Development Fund, high net worth individuals and Australian family offices. A Series A financing round is planned for H1 2025, which will ideally be anchored by a US based VC.
