Insignis Therapeutics Receives FDA Fast Track Designation for IN-001 for Anaphylaxis Treatment

August 13, 2024

  • Convenient, needle-free, and simple-to-use liquid epinephrine sublingual spray
  • Suitable for all patients, including those with dry mouth conditions, as it does not require saliva for dissolution or absorption
  • Unprecedented stability under extreme temperature conditions from -20℃/-4°F to 60℃/140°F, making it the first rugged real-world epinephrine product that can endure extreme heat and cold
  • Considerably Longer shelf life than competition products, reducing the need for frequent replacements and ensuring product integrity and performance

NORTH HAVEN, Conn., Aug. 13, 2024 (GLOBE NEWSWIRE) – Insignis Therapeutics, a pharmaceutical company focused on developing innovative allergy and anaphylaxis treatments, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational drug, IN-001, a novel needle-free epinephrine delivery system utilizing a sublingual spray in a disposable device.

The FDA’s Fast Track program is designed to expedite the product review and facilitate the development of drugs that treat serious conditions and address unmet medical needs. This designation for IN-001 underscores the critical need for innovative solutions in the management of severe allergic reactions and anaphylaxis and offers hope for millions of patients worldwide who are at risk of life-threatening allergic events seeking a more convenient and durable alternative to needle-based epinephrine products.

IN-001 represents multiple significant advancements in the field of anaphylaxis treatment. Unlike traditional epinephrine auto-injectors, IN-001 utilizes an FDA-approved epinephrine prodrug sprayed under the tongue, providing rapid and effective epinephrine administration without the use of needles. This breakthrough addresses common barriers associated with needle-based devices, such as needle phobia and the risk of incorrect administration, making emergency treatment more accessible, reliable and less intimidating for patients.

In addition, unlike the epinephrine auto-injectors and epinephrine nasal spray products, IN-001 sublingual spray is not temperature sensitive and remains stable and usable under extreme temperature conditions from -20℃/-4°F to 60℃/140°F. This makes IN-001 the first rugged epinephrine product that can be carried and used under any temperature conditions without risking potency loss or product failures. This breakthrough addresses the issues of temperature sensitivity, poor stability, and short shelf life plaguing traditional epinephrine auto-injectors, reducing the need for frequent replacements and providing significant long-term financial benefits to patients and their families.

“We are thrilled to receive Fast Track designation from the FDA for IN-001,” said Mingbao Zhang, PhD, MBA, CEO of Insignis Therapeutics. “This recognition validates the urgent need for a needle-free epinephrine delivery system and brings us one step closer to providing a safer, less temperature-sensitive, more stable, and user-friendly option for patients at risk of anaphylaxis. We look forward to working closely with the FDA to accelerate the development and review process, ensuring that IN-001 can reach those in need as quickly as possible.”

The Fast Track designation allows for more frequent interactions with the FDA, eligibility for priority review, and the possibility of accelerated approval, all of which can significantly shorten the time to market for IN-001. Insignis Therapeutics is committed to advancing the development of IN-001 through rigorous clinical trials and regulatory milestones to demonstrate its safety and efficacy.

For more information about Insignis Therapeutics, please visit www.insignisrx.com.

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 an injection of epinephrine, which can reverse the symptoms. Individuals at risk of anaphylaxis are often advised to carry an epinephrine auto-injector and wear medical identification to alert others to their condition.

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
mzhang@insignisrx.com

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.