Oversubscribed Seed Round Accelerates Nasdepi®'s Journey as the First Dry Powder Nasal, Heat-Stable Treatment for Anaphylaxis
RALEIGH, NORTH CAROLINA / ACCESS Newswire / January 21, 2025 / Belhaven Biopharma, a leader in dry powder nasal drug delivery systems, announces the launch of a new clinical study designed to evaluate the commercial dose of Nasdepi®, an epinephrine product for intranasal administration, and further establish its potential as a transformative treatment for severe allergic reactions.
Belhaven also announces the completion of its fourth funding round, which closed oversubscribed at $11 million, exceeding the company's initial goal of $7.5 million for this round. This milestone will fund the manufacture of NDA registration lots that will support the remaining clinical program as well as drive FDA interactions to prepare for the pivotal biocomparability study for Nasdepi®.
"This next clinical study is a crucial step in confirming the safety, efficacy, and bioavailability of Nasdepi® as demonstrated in our earlier trial and in comparison to traditional autoinjectors," said Scott Lyman, CEO of Belhaven Biopharma. "By testing the product under real-world conditions, including a nasal allergen challenge, we aim to confirm its potential as a reliable, easy to use solution for anaphylaxis, bringing us closer to addressing critical gaps in allergy care."
By introducing a nasal allergen challenge, the study will simulate real-world conditions, providing critical insights into the product's performance in the presence of nasal congestion or irritation. The study's primary goals are to determine the amount of epinephrine absorbed into the bloodstream when administered nasally versus intramuscularly and confirm the optimal dose to ensure effective and consistent treatment. These results will lay the groundwork for the pivotal clinical trial and regulatory approval, bringing Nasdepi® one step closer to the market.
The company's innovative dry powder nasal approach aims to address critical barriers in anaphylaxis treatment, including needle phobia, temperature sensitivity, and complex administration, while offering a faster, simpler, and more reliable alternative to epinephrine autoinjectors. Nasdepi® offers a needle-free, heat-stable, and easy-to-use alternative. Its innovative delivery system ensures fast absorption, making it a life-saving option in critical situations where time is of the essence.
About Belhaven Biopharma
Belhaven Biopharma is a clinical stage pharmaceutical research company specializing in developing life-saving medications delivered quickly, effectively, and painlessly with a simple, dry powder, single-use nasal device. They are at the forefront of developing nasal dry powder epinephrine, which is revolutionizing emergency-use epinephrine delivery and expanding global access. Nasdepi®, Belhaven's lead program, is the first dry powder nasal device for treating life-threatening allergic reactions.
For more information, visit https://belhavenbio.com.
Contact Information
Janie Mackenzie
Vice President of Public Relations
janie@ascendantgroupbranding.com
267.969.4992
SOURCE: Belhaven Biopharma
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