Insignis Therapeutics has announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding its clinical development program for IN-001, a needle-free epinephrine sublingual spray intended for the emergency treatment of anaphylaxis. This positive regulatory response marks a significant advancement for Insignis, potentially offering a more convenient and accessible alternative to traditional epinephrine injections. The treatment is based on an FDA-approved epinephrine prodrug designed to enhance stability and absorption.
Clinical Trial Pathway
The FDA's feedback confirms a clear pathway to approval for IN-001, focusing on pharmacokinetic (PK) and pharmacodynamic (PD) trials in healthy subjects. These trials will involve bracketing the PK of IN-001 with standard epinephrine injections. Notably, the FDA has indicated that no placebo-controlled efficacy studies will be required. Successful completion of these trials could lead to a New Drug Application (NDA) submission and potential FDA approval for the emergency treatment of severe allergic reactions, including those caused by insect stings or bites, foods, drugs, and idiopathic or exercise-induced anaphylaxis.
Fast Track Designation and Development
IN-001 received Fast Track designation from the FDA in July 2024, which is expected to expedite the regulatory review process. This designation underscores the urgent need for innovative anaphylaxis treatments. According to Mingbao Zhang, PhD, MBA, CEO of Insignis Therapeutics, this positive feedback represents a significant milestone in transforming anaphylaxis treatment, offering a potentially life-saving, user-friendly alternative to injectable epinephrine, thereby reducing the fear and complexity associated with traditional autoinjectors.
Unique Formulation and Stability
One of the key advantages of IN-001 is its unique formulation, which remains stable at temperatures as high as 140°F (60°C) and resists freezing down to -74°F (-59°C). This stability positions IN-001 as a reliable treatment option in diverse climates, potentially making it the preferred needle-free solution for treating severe allergic reactions if approved.
About Anaphylaxis
Anaphylaxis is a severe, potentially life-threatening allergic reaction that can occur rapidly, often within minutes of exposure to an allergen. Common triggers include certain foods, insect stings, medications, and latex. The condition is characterized by a sudden release of chemicals in the body, leading to symptoms such as swelling, hives, difficulty breathing, a drop in blood pressure, and, in severe cases, loss of consciousness. Immediate medical treatment is crucial, typically involving systemic epinephrine administration, which can reverse the symptoms.
