Belhaven Biopharma Reveals Promising Nasdepi Trial Outcomes: A Needle-Free Epinephrine Solution for Severe Allergies

Belhaven Biopharma announced promising results from its Phase 1 clinical trial of Nasdepi, a nasal dry powder epinephrine device for treating anaphylaxis due to severe allergic reactions. The study highlights Nasdepi's potential as a needle-free, user-friendly, and cost-effective alternative to traditional epinephrine injections, with added benefits of extended shelf life and heat resistance.

Key points from the trial include:

A single dose of Nasdepi achieved the same drug levels as FDA-approved treatments for severe allergies.
Nasdepi was safe and well tolerated, with no serious adverse events reported.
Clinical data suggest Nasdepi may deliver epinephrine into the bloodstream faster and at sustained concentrations, potentially making it more effective than injections in treating anaphylaxis.
The device offers a safe, user-friendly, and cost-effective alternative to intramuscular injection autoinjectors, with a longer shelf life and potential for global accessibility.
Following an oversubscribed $3.6 million financing round, Belhaven is preparing for a $12-15 million Series A round to further develop Nasdepi. CEO Scott Lyman emphasized the significance of the trial results, noting Nasdepi's potential to revolutionize emergency anaphylaxis treatment and improve accessibility for patients worldwide.

The trial involved 12 healthy volunteers and compared two dose levels of Nasdepi to 0.3 mg and 0.5 mg intramuscular injections. Both dose levels of Nasdepi were rapidly absorbed, achieving clinically relevant epinephrine levels faster than the IM injections, with corresponding effects on heart rate and blood pressure.

Belhaven Biopharma specializes in developing life-saving medications using a dry powder, single-use nasal device, aiming to revolutionize emergency epinephrine delivery and expand global access. Nasdepi is their lead program for treating life-threatening allergic reactions.

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