De Motu Cordis (DMC) Applauds ARS Pharma's FDA Approval of Neffy, Expanding Patient Options to Needle-Free Epinephrine Delivery and Inspiring Confidence in Our Own Development Efforts
De Motu Cordis (DMC) Applauds ARS Pharma's FDA Approval of Neffy, Expanding Patient Options to Needle-Free Epinephrine Delivery and Inspiring Confidence in Our Own Development Efforts
BRISBANE, Australia, Aug. 16, 2024 /PRNewswire/ -- 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.
De Motu Cordis(DMC)非常高興地承認和熱情地讚揚ARS Pharma的Neffy,這是美國FDA首次批准用於治療過敏反應的無針鼻內腎上腺素輸送裝置。這一具有開創性的批准於8月9日宣佈,是擴大危及嚴重過敏反應患者應急治療選擇的重要一步。
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.
DMC認爲這一批准是對505(b)(2)法規途徑在過敏反應治療領域的適用性的關鍵確認。對於像過敏反應這樣的緊急症狀,可能無法進行廣泛的三期臨床研究,因此這種途徑尤其關鍵。這一進展不僅加強了我們推進我們自己的臨床計劃的承諾,該計劃旨在通過吸入(IH)給藥實現更快的腎上腺素吸收的潛力,而且還強調了提供更加患者友好的選擇的重要性。
"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."
「我們很高興看到無針治療的批准,」DMC的創始人、CMO、董事John Fraser教授說。「Neffy的批准加強了DMC和整個藥物輸送社區推動創新邊界的動力。我們認爲,通過吸入更快到達的腎上腺素可能不僅對過敏反應而且對其他緊急醫療治療都有價值。」
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.
隨着我們繼續開發工作,Neffy的批准增強了我們致力於提供尖端解決方案以改善危急情況下的患者護理和安全的承諾。
"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首席執行官Peter O'Neill表示:「在未來3至5年內,我們預計將有更多更新型治療過敏反應的批准,這主要是由於不斷創新和更新技術的批准所推動。隨着這些進展,我們預計可尋址的患者市場將擴大2至3倍。單在美國,只有8%的I型嚴重過敏反應患者擁有活動的自動注射器處方,凸顯出了重要的未滿足需求。」
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.
DMC正在積極開發DMC-IH1,這是一種專門設計用於社區緊急醫學的專有藥物輸送器平台技術。該平台正在被量身定製,以便非醫療訓練有素的患者和護理人員能夠更輕鬆地使用,特別是在需要快速反應的情況下,可以提供更易於接近和更有效的治療選擇。
About DMC
關於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.
「DMC是一家臨床階段的製藥公司」。DMC由John Fraser教授在澳大利亞布里斯班創立,他是一位重症醫學專家、開創性的臨床醫生、研究人員和公司創始人。John也是重症監護研究小組的創始人,並是BIVACOR Pty Ltd的聯合創始人。John共同創立了COVID-19重症監護協會,該協會促進了全球ICU收集了超過3500萬數據點並協助制定治療路徑。
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.
自成立以來,DMC在澳大利亞主要通過種子輪融資籌集了超過2100萬美元。迄今爲止,大部分資金都是通過昆士蘭州業務發展基金、高淨值個人和澳大利亞家族辦公室獲得的。預計將在2025年上半年進行A輪融資,這將是由美國VC牽頭的理想融資。
SOURCE De Motu Cordis
資料來源:De Motu Cordis