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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.

Continue reading “Insignis Therapeutics Receives Positive FDA Feedback on IN-001 Clinical Program for Needle-Free Anaphylaxis Treatment”

• Rapid epinephrine absorption with a time to reach the 100 pg/mL threshold concentration in 9 minutes after dosing
• Sustained pharmacokinetics (PK) with plasma epinephrine concentration remaining above 100 pg/mL for 2 hours post-dose, ensuring a durable treatment effect
• Safe and well tolerated, with only mild, transient, and self-resolving adverse events (AEs) reported

NORTH HAVEN, Conn., Oct. 07, 2024 (GLOBE NEWSWIRE) — Insignis Therapeutics, a leader in innovative allergy and anaphylaxis treatments, is excited to announce positive Phase 1 results for IN-001, an investigational liquid epinephrine sublingual spray for anaphylaxis. This study, A24-1889, demonstrated that IN-001 is highly effective and easy to use, offering a promising alternative to current needle-based treatments.

Continue reading “Insignis Therapeutics Announces Positive Results from Phase 1 Clinical Study of IN-001 Liquid Epinephrine Sublingual Spray for Anaphylaxis”

• 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

Continue reading “Insignis Therapeutics Receives FDA Fast Track Designation for IN-001 for Anaphylaxis Treatment”