Insignis Therapeutics Receives Positive FDA Feedback On IN-001 Clinical Program For Needle-Free Anaphylaxis Treatment

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• FDA feedback confirms clear pathway to approval for IN-001
• Key trial focus: PK/PD in healthy subjects, with PK bracketed by standard epinephrine injections
• No placebo-controlled efficacy studies required
  

NORTH HAVEN, Conn., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Insignis Therapeutics, a leader in innovative allergy and anaphylaxis treatments, announced today that it has received positive feedback from the U.S. Food and Drug Administration (FDA) with regard to its clinical development program for IN-001, a needle free epinephrine sublingual spray designed for the emergency treatment of anaphylaxis. IN-001 is based on an FDA-approved epinephrine prodrug that enhances stability and absorption.

The positive regulatory response marks a pivotal step forward for Insignis and comes after a successful phase I study demonstrating that IN-001 achieves epinephrine pharmacokinetic (PK) profiles comparable to traditional epinephrine injections but with the convenience and ease of needle-free administration.

The proposed PK/PD trials in healthy human subjects, if successful, could lead to an NDA submission and the potential FDA approval of IN-001 for the emergency treatment of severe allergic reactions (Type I) to insect stings or bites, foods, drugs, and other allergens as well as anaphylaxis of unknown cause (idiopathic anaphylaxis) or exercise induced anaphylaxis.

The U.S. Food and Drug Administration (FDA) granted IN-001 Fast Track designation for anaphylaxis in July 2024. This designation allows for a faster regulatory review process, supporting Insignis' goal of expediting the availability of this innovative therapy.

"This favorable FDA feedback is a significant milestone in our journey to transform anaphylaxis treatment," said Mingbao Zhang, PhD, MBA, CEO of Insignis Therapeutics. " IN-001 offers a potentially life-saving, user-friendly alternative to injectable epinephrine, helping reduce the fear and complexity associated with traditional autoinjectors. We are excited to continue working with the FDA to bring this groundbreaking product to market."

Unlike the existing epinephrine products, IN-001's unique formulation remains stable at temperatures as high as 140°F (60°C) and resists freezing down to -74°F (-59°C), positioning it as a reliable treatment option in any climate. If approved, IN-001 could become the preferred, needle-free solution for treating severe allergic reactions.

For more information about Insignis Therapeutics, please visit .

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.

About Insignis Therapeutics
Insignis Therapeutics is dedicated to developing cutting-edge treatments for severe allergies and anaphylaxis. By leveraging advanced technology and scientific expertise, Insignis aims to improve the quality of life for patients worldwide through innovative, effective, and accessible medical solutions.

Company Contact:
Mingbao Zhang, PhD
CEO, Insignis Therapeutics
203-570-8879
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This press release contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those expressed or implied in these statements.

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