- Belhaven Biopharma has launched a new clinical study to evaluate the commercial dose of Nasdepi, an epinephrine product for intranasal administration.
- The company has also completed its oversubscribed $11 million funding round to support the manufacture of NDA registration lots and prepare for FDA interactions.
Belhaven Biopharma has announced the launch of a new clinical study designed to evaluate the commercial dose of Nasdepi, an intranasal epinephrine product aimed at treating severe allergic reactions. The company has secured $11 million in funding through its fourth funding round, exceeding its initial target of $7.5 million. The funds will be used to manufacture NDA registration lots and facilitate interactions with the FDA, advancing Nasdepi closer to regulatory approval.
The new clinical trial will assess the safety, efficacy, and bioavailability of Nasdepi, building on earlier trial results. A nasal allergen challenge will simulate real-world conditions, including nasal congestion or irritation, to provide critical insights into the product’s performance. The study’s primary goal is to confirm the optimal dose of Nasdepi for effective treatment and compare its performance to traditional autoinjectors. Results from this study will inform the pivotal clinical trial required for regulatory approval.
Scott Lyman, CEO of Belhaven Biopharma, emphasized the importance of this study, stating, “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.”
Nasdepi’s dry powder nasal delivery system offers a needle-free, heat-stable, and easy-to-use alternative to epinephrine autoinjectors. It aims to overcome key challenges in anaphylaxis treatment, including needle phobia, temperature sensitivity, and complex administration, while ensuring fast absorption for quick action in critical situations.