Orexo AB has announced the dosing of the first participants in a new study evaluating OX640, an intranasal rescue medication containing powder-based epinephrine, for severe allergic reactions including anaphylaxis. The study, designated OX640-002, focuses on subjects with allergic rhinitis (hay fever) and aims to assess the absorption of epinephrine when allergic symptoms are present in the nose. Results are anticipated in early 2025.
Evaluating Epinephrine Absorption Under Allergic Conditions
The OX640-002 study is a cross-over trial involving 30 participants with allergic rhinitis. The study design includes four treatment periods. In one period, participants will receive a small dose of an allergen sprayed into the nose to induce an allergic reaction before administration of OX640. This aims to mimic conditions during anaphylaxis, where nasal allergic symptoms can occur. The absorption of epinephrine from OX640 under these conditions will be compared to its absorption without the allergen, as well as to a commercial intramuscular epinephrine product. A fourth period will assess the dose proportionality of OX640. Blood pressure and heart rate will also be monitored to evaluate the overall effect of OX640.
Addressing Regulatory and Healthcare Provider Needs
According to Robert Rönn, SVP and Head of R&D at Orexo, ensuring OX640's effectiveness even with nasal allergic symptoms is crucial due to the life-threatening nature of anaphylaxis. The study is designed to meet key regulatory requirements and is an important step toward regulatory approval. The performance of OX640 under allergic rhinitis conditions has been a frequent topic in discussions with healthcare providers and potential partners.
Financial Implications and AmorphOX Technology
The study is projected to cost SEK 11 million, with the majority of these costs being recognized in 2024, aligning with the company's financial outlook for the year. OX640 utilizes Orexo's proprietary AmorphOX drug delivery platform, which enhances drug absorption and stability. AmorphOX is a powder composed of drug, carrier materials, and other ingredients, presented as an amorphous composite that ensures chemical and physical stability, as well as rapid dissolution. This technology has demonstrated rapid and extensive drug exposure in multiple clinical studies.
About OX640
OX640 is designed as a needle-free, convenient, and rapidly acting rescue medication for severe allergic reactions, including anaphylaxis. Its unique properties offer the potential for long shelf-life and flexible storage across varying temperatures.
