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

• 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.

IN-001’s unique formulation remains potent at temperatures as high as 140°F (60℃) and resists freezing down to -74°F (-59℃), 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.

The U.S. Food and Drug Administration (FDA) granted IN-001 Fast Track designation in July 2024.

“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.”

This 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. Results showed that both doses produced efficacious pharmacokinetic (PK) profiles comparable to those of epinephrine injection and nasal spray products reported in literature.

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, ensuring long-lasting protection. Importantly, 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.

Table 1 illustrates the proportion of subjects who failed to reach 100 pg/mL following a single dose across various epinephrine products from previous and published studies.

Table 1. Proportion of Subjects Who Failed to Reach 100 pg/mL Following a Single Dose

_{¹ARS Study EPI 15 cited by FDA in Briefing Material (Table 8, page 30) for Pulmonary-Allergy Drugs Advisory Committee Meeting held on May 11, 2023 (https://www.fda.gov/media/167986/download). File name: 20230511-PADAC Backgrounder-FDA. ²Aquestive Therapeutics Form 8-K Dated March 14, 2024. Pivotal Study and FDA Meeting Supplemental Slides: Slide 13}

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.

“The results of the A24-1889 study provide compelling evidence that IN-001 could be a safer and more reliable needle-free option for epinephrine dosing in treating severe allergic reactions,” said Mingbao Zhang, PhD, MBA, CEO of Insignis Therapeutics. “We believe that, if approved, IN-001’s simplicity of sublingual spray dosing, reliable epinephrine delivery, and resistance to temperature extremes will make it an ideal rescue medication for patients who need immediate access to emergency epinephrine medication, regardless of their location or the weather conditions.”

With these promising results, Insignis Therapeutics is eager to advance IN-001 through further clinical trials and bring this groundbreaking solution to market as quickly as possible. The company remains committed to improving the quality of life for patients with life-threatening allergies.

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 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
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.