Belhaven Biopharma to Present Phase 1 Needle-Free Epinephrine Powder Data at ACAAI Meeting

Belhaven Biopharma, a prominent player in the field of nasal drug delivery technologies and emergency allergy treatments, is gearing up to unveil pivotal clinical data from its Phase 1 study on Nasdepi®, an innovative intranasal epinephrine powder. This significant presentation is slated for October 25, at the 2024 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, taking place at the Boston Convention & Exhibition Center.

The Phase 1 study, titled “Phase 1 Study Evaluating the Pharmacokinetics, Bioavailability, Safety, and Tolerability of Intranasally Administered Epinephrine Powder,” will showcase findings that position Nasdepi® as a pioneering alternative to traditional intramuscular epinephrine injections, particularly in emergency scenarios where speed and efficacy are paramount.

The key findings from this study underscore Nasdepi®'s potential. The study demonstrated that Nasdepi® (administered in 3.5 mg and 5.5 mg doses) resulted in greater overall drug exposure compared to the standard 0.3 mg and 0.5 mg intramuscular epinephrine. Moreover, Nasdepi® achieved effective and peak concentrations in the bloodstream significantly faster than FDA-approved intramuscular epinephrine, making it a highly responsive option for urgent treatment needs. Specifically, Nasdepi® reached required bloodstream levels 48% faster and peak concentrations 22% quicker than intramuscular injections.

Belhaven Biopharma's CEO, Scott Lyman, emphasized the significance of these findings, highlighting the company's commitment to developing groundbreaking treatments. He noted that Nasdepi® offers an easy-to-use, temperature-resistant, and needle-free alternative for emergency allergy care, which could revolutionize the current methods of administering epinephrine.

The study compared Nasdepi® to conventional intramuscular epinephrine in healthy subjects, revealing rapid increases in plasma concentration and meaningful plasma levels such as the time to achieve a 100 pg/mL increase above baseline and equivalent or higher peak concentration (Cmax) versus intramuscular injections. These factors are crucial in managing time-sensitive allergic reactions. Additionally, the study confirmed moderate increases in heart rate and systolic blood pressure, indicating effective systemic distribution of the drug. Treatments were generally safe and well tolerated, with no serious adverse events reported, and all treatment-related events were resolved by the end of the study.

Belhaven Biopharma plans to present further research on Nasdepi®'s dry powder formulation at the Drug Delivery to the Lungs (DDL) Conference on December 12 in Edinburgh, Scotland. This presentation will shed light on Nasdepi®'s reliable deposition under real-life conditions, such as nasal congestion, and its stability under extreme heat. Chief Operations Officer Brian Taubenheim will discuss these findings, emphasizing Nasdepi®'s potential as a reliable, needle-free emergency allergy treatment.

Belhaven Biopharma is a clinical-stage pharmaceutical research company dedicated to developing life-saving medications that can be delivered quickly, effectively, and painlessly through a simple, dry powder, single-use nasal device. The company's flagship program, Nasdepi®, represents a major advancement in emergency-use epinephrine delivery, aiming to broaden global access to this critical treatment.