Insignis Therapeutics announced positive Phase 1 results for IN-001, an investigational liquid epinephrine sublingual spray for anaphylaxis. The study (A24-1889) demonstrated rapid absorption and sustained efficacy, offering a potential needle-free alternative to current epinephrine delivery systems.
Key Findings from the Phase 1 Study
The Phase 1 study, a single-dose, two-period, sequential crossover study, involved six healthy adult subjects who received a single 4.53 mg IN-001 spray in Period I and a single 9.06 mg IN-001 spray in Period II one week later. The results indicated that both doses produced efficacious pharmacokinetic (PK) profiles comparable to those of epinephrine injection and nasal spray products.
Notably, IN-001 achieved the FDA-cited 100 pg/mL plasma epinephrine concentration threshold within 9 minutes or less for both doses. The 100 pg/mL concentration is a target considered important to achieve hemodynamic stabilization and halt the progression of anaphylaxis. The higher 9.06 mg dose sustained plasma epinephrine levels above 100 pg/mL for 2 hours post-dose. 100% of subjects treated with the 9.06 mg dose reached or exceeded this threshold within the clinically relevant first 30 minutes after dosing, outperforming existing epinephrine products including the recently approved epinephrine nasal spray Neffy, where 2% to 17% of subjects failed to reach 100 pg/mL within the same timeframe based on publicly available data.
Safety and Tolerability
IN-001 was safe and well-tolerated, with all treatment-emergent adverse events being mild, transient, and self-resolving without any need for intervention. The absence of severe side effects further supports the potential of this product to offer a safe and effective alternative to existing epinephrine options.
Addressing Unmet Needs in Anaphylaxis Treatment
Traditional epinephrine delivery systems often face challenges such as needle phobia and temperature sensitivity. IN-001's unique formulation remains potent 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 under any weather conditions. If approved, IN-001 could become the preferred, needle-free solution for treating severe allergic reactions to food, medications, and insect stings that can lead to life-threatening anaphylaxis.
Expert Commentary
"The results from this Phase 1 study are very encouraging," said Dr. Julie Wang, MD, Professor of Pediatrics at Icahn School of Medicine at Mount Sinai. "IN-001 not only demonstrates rapid absorption and sustained efficacy, but it also addresses many of the concerns with traditional epinephrine delivery systems, such as needle phobia and temperature sensitivity. This needle-free option has the potential to greatly improve patient outcomes."
Regulatory Status and Future Plans
The U.S. Food and Drug Administration (FDA) granted IN-001 Fast Track designation in July 2024. Insignis Therapeutics is eager to advance IN-001 through further clinical trials and bring this groundbreaking solution to market as quickly as possible.
