Insignis Therapeutics Reports Positive Phase 1 Results for IN-001 Epinephrine Spray

Insignis Therapeutics, a pioneering company in allergy and anaphylaxis treatments, has announced promising Phase 1 results for IN-001, a sublingual liquid epinephrine spray designed for anaphylaxis. The study, A24-1889, showcases that IN-001 is not only effective but also user-friendly, providing a viable alternative to conventional needle-based treatments.

IN-001 boasts a unique formulation that remains potent at extreme temperatures, from as high as 140°F (60℃) to as low as -74°F (-59℃). This resilience makes it a dependable treatment option, regardless of weather conditions. If approved, IN-001 could become the go-to needle-free solution for severe allergic reactions, such as those triggered by food, medications, and insect stings, which can lead to life-threatening anaphylaxis.

The U.S. Food and Drug Administration (FDA) granted Fast Track designation to IN-001 in July 2024, expediting its development and review process.

Dr. Julie Wang, MD, Professor of Pediatrics at Icahn School of Medicine at Mount Sinai, commented on the study's positive results, stating that IN-001 not only shows rapid absorption and sustained efficacy but also addresses issues associated with traditional epinephrine delivery systems, including needle phobia and sensitivity to temperature fluctuations. She emphasized that this needle-free option has the potential to significantly improve patient outcomes.

The Phase 1 study was a single-dose, two-period, sequential crossover involving six healthy adult subjects. Participants received a single 4.53 mg dose of IN-001 spray in the first period and a single 9.06 mg dose in the second period one week later. The results revealed that both doses provided effective pharmacokinetic (PK) profiles akin to those of existing epinephrine injection and nasal spray products.

Remarkably, IN-001 reached the FDA-cited 100 pg/mL plasma epinephrine concentration threshold in less than 9 minutes for both doses. This concentration is crucial for achieving hemodynamic stabilization and halting the progression of anaphylaxis. The higher 9.06 mg dose maintained plasma epinephrine levels above 100 pg/mL for 2 hours post-dose, ensuring extended protection. Furthermore, 100% of subjects treated with the 9.06 mg dose reached or exceeded this threshold within the first 30 minutes after dosing, outperforming other epinephrine products, including the recently approved epinephrine nasal spray Neffy, where 2% to 17% of subjects did not meet the 100 pg/mL threshold within the same timeframe.

IN-001 was deemed safe and well-tolerated, with all adverse events being mild, transient, and self-resolving, requiring no intervention. The absence of severe side effects underscores its potential as a safe and effective alternative to current epinephrine options.

Mingbao Zhang, PhD, MBA, CEO of Insignis Therapeutics, stated that the A24-1889 study's results strongly suggest that IN-001 could be a safer, more reliable needle-free option for epinephrine dosing in treating severe allergic reactions. Zhang noted that if approved, the sublingual spray's ease of use, dependable epinephrine delivery, and resistance to temperature extremes would make it an ideal rescue medication for patients needing immediate access to emergency epinephrine, regardless of their location or the weather.

Given these encouraging results, Insignis Therapeutics is keen to advance IN-001 through further clinical trials and expedite its market entry. The company remains dedicated to enhancing the quality of life for patients with life-threatening allergies.

Anaphylaxis is a severe, potentially life-threatening allergic reaction that can occur within minutes of exposure to an allergen. Common triggers include certain foods, insect stings, medications, and latex. Symptoms include swelling, hives, difficulty breathing, a drop in blood pressure, and, in severe cases, loss of consciousness. Immediate medical treatment, often involving systemic epinephrine administration, is crucial in reversing the symptoms.