Quadmedicine Applies for Phase 1 Clinical Trial Plan for Emergency Anaphylaxis Treatment
Quadmedicine has submitted an Investigational New Drug (IND) application for its emergency treatment for severe allergic reactions, "EpiQ Patch," to the Ministry of Food and Drug Safety.
According to Quadmedicine on September 15, the clinical trial will be conducted at Korea University Anam Hospital, where healthy adult participants will receive a single dose of both EpiQ Patch and the conventional epinephrine injection, EpiPen. The study aims to compare the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as evaluate safety and tolerability. The trial period is set for 12 months from the date of initial approval by the institutional review board (IRB).
EpiQ Patch is being developed as a patch-type pharmaceutical that delivers epinephrine through micro-sized microneedles into the skin. By providing a non-intranasal administration route and a compact patch form, the goal is to enhance portability and ease of use in emergencies. The company also aims to ensure the stability of the solidified drug formulation for storage and distribution, pursuing development as an emergency treatment that can be carried regularly. Through this trial, Quadmedicine plans to secure data on initial drug absorption and pharmacodynamic responses, which will be necessary for its partner companies' subsequent development and commercialization decisions. The company also intends to accumulate experience in applying the platform within the emergency treatment field.
Improvements in epinephrine delivery methods have previously led to large-scale contracts overseas. For example, ARS Pharmaceuticals, the developer of Neffy, signed an overseas commercialization contract with ALK in 2024 worth up to $465 million, including an upfront payment of $145 million and additional milestone-based payments. Royalties from sales were stipulated separately. This is recognized as a precedent demonstrating the commercial value of innovative delivery technologies.
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A Quadmedicine representative stated, "This IND submission is part of a step-by-step process to fulfill development tasks agreed upon with our partner company, highlighting how pharmaceutical development demands are translating into the microneedle platform business. As we accumulate development outcomes, we expect this to boost our partner's global commercialization potential and draw greater interest from international pharmaceutical companies, while also having a positive impact on further platform collaborations and milestone-based business expansion."
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