Belhaven Biopharma Announces Groundbreaking Clinical Results for Nasdepi, the Revolutionary Nasal Dry Powder Epinephrine Product

RALEIGH, N.C., February 8, 2024 (Newswire.com) - Belhaven Biopharma, a leader in innovative treatments for severe allergic reactions, today shared promising results from its Phase 1 clinical trial of Nasdepi, a nasal dry powder epinephrine device for the treatment of anaphylaxis due to severe allergic reactions. This successful study underscores its potential to revolutionize the management of severe allergic reactions by offering a needle-free alternative that is more accessible, user-friendly, and cost-effective. With its extended shelf life and heat resistance, Nasdepi promises to be a reliable option over liquid treatments with the additional advantage of being readily available on demand, breaking down barriers to epinephrine access and changing the landscape of emergency anaphylaxis treatment on a global scale.

Key Takeaways:

• A single dose of Nasdepi administered to healthy human subjects achieves the same drug levels as FDA-approved treatments for anaphylaxis associated with severe allergies.
• Nasdepi was safe and generally well tolerated by subjects with no serious adverse events.
• Clinical data supports that Nasdepi may be a superior alternative to injections by delivering epinephrine into the bloodstream faster at sustained concentrations which may prove more effective in alleviating the allergic response which leads to anaphylaxis.
• Research data continues to support that Nasdepi offers a safe, user-friendly, cost-effective alternative to intramuscular injection (IM) autoinjectors, with a longer shelf life and potential for global accessibility.
• Belhaven's Next Steps: After raising an oversubscribed $3.6 million round against a target of $3 million in their most recent financing, Belhaven is preparing for a $12-15 million Series A financing round to complete the development of Nasdepi.

Scott Lyman, CEO of Belhaven Biopharma, expressed enthusiasm about the results, stating, "The successful outcomes of the Nasdepi Phase 1 study marks a significant milestone in our mission to innovate and improve emergency treatment for severe allergic reactions. The study confirms Nasdepi’s potential to replace traditional autoinjectors and the potential to revolutionize how we approach anaphylaxis treatment, making it more accessible and less intimidating for patients worldwide."

The study was a comparative bioavailability study performed in 12 healthy volunteers assessing two different dose levels compared to 0.3mg and 0.5mg intramuscular (IM) injections. Both dose levels of Nasdepi were rapidly absorbed and achieved clinically relevant epinephrine levels faster when compared to both IM injections. In addition, both doses showed corresponding effects on heart rate and blood pressure, a pharmacodynamic response relevant for the treatment of anaphylaxis and natural biologic response to epinephrine. There were no severe adverse events (SAEs) and safety findings were generally consistent with known effects of epinephrine and nasal administration.

Alongside this clinical milestone, Belhaven Biopharma has successfully closed its bridge financing round, raising just over $3.6 million against a target of $3 million, marking a 20% oversubscription. This financial achievement reflects strong investor confidence in Belhaven's vision and its lead product, Nasdepi.

Looking ahead, Belhaven is preparing to launch a Series A financing round, with a target of raising between $12 and $15 million. These funds will support the further development of Nasdepi, including advancing through subsequent clinical trials and towards commercialization, as well as expanding the company's pipeline of innovative treatments for severe allergic reactions and other emergency medicines.

About BBP01-CLN-101 

BBP01-CLN-101 is a Phase 1, Open Label, Single Sequence, Dose Finding Study to Evaluate the Pharmacokinetics, Bioavailability, Safety, and Tolerability of Single Doses of BBP01 (Epinephrine) Intranasal Powder at 2 Dose Levels versus 0.3 mg and 0.5 mg Intramuscular Injection Doses of Epinephrine in Healthy Subjects.

About Belhaven Biopharma

Belhaven Biopharma is a 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 is Belhaven’s lead program being developed to treat life-threatening allergic reactions.

Source: Belhaven Biopharma