Insignis Therapeutics has announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding its IN-001 clinical program. IN-001 is an epinephrine sublingual spray designed for the emergency treatment of anaphylaxis, offering a needle-free alternative to traditional injectable epinephrine. This positive response from the FDA could potentially pave the way for a New Drug Application (NDA) submission, bringing the innovative treatment closer to market.
The FDA-approved epinephrine prodrug used in IN-001 is designed to enhance both stability and absorption, addressing key limitations of existing treatments. This needle-free approach aims to provide a more convenient and less intimidating option for patients and caregivers in emergency situations.
Phase I Study Results
The positive feedback follows a Phase I study that demonstrated IN-001 achieved comparable epinephrine pharmacokinetic (PK) profiles to injections. Notably, the company is not required to conduct placebo-controlled efficacy studies, streamlining the development pathway. The proposed PK/pharmacodynamic (PD) trials in healthy individuals could further support FDA approval.
Data from Phase I study A24-1889 highlighted the effectiveness and ease of use of IN-001. The study, involving six healthy adults, showed that IN-001 rapidly achieved the FDA’s required plasma epinephrine concentration threshold of 100 pg/mL.
Potential Impact on Anaphylaxis Treatment
If successful, IN-001 could be used to treat critical allergic reactions, including anaphylaxis of unknown causes and exercise-induced anaphylaxis. Anaphylaxis is a serious, rapid allergic reaction that can be life-threatening, characterized by symptoms such as swelling, hives, and difficulty breathing. The availability of a needle-free option could significantly improve the speed and ease of treatment administration, potentially saving lives.
In July 2024, the FDA granted IN-001 fast track designation, expediting the review process and supporting the company’s aim to quickly bring this therapy to market.
Management Perspective
Insignis Therapeutics CEO Mingbao Zhang stated, “This favorable FDA feedback is a significant milestone in our journey to transform anaphylaxis treatment. IN-001 offers a potentially life-saving, user-friendly alternative to injectable epinephrine, helping reduce the fear and complexity associated with traditional autoinjectors. We are excited to continue working with the FDA to bring this groundbreaking product to market.”
