Orexo begins new OX640 study in allergic rhinitis patients

Orexo AB, a Swedish pharmaceutical company, has initiated a new clinical study involving its intranasal rescue medication, OX640. This medication is designed to treat severe allergic reactions, including anaphylaxis, using powder-based epinephrine. The innovative product leverages Orexo's proprietary drug delivery platform, AmorphOX, which has previously shown promising results in phase 1 clinical trials involving healthy volunteers. The current study aims to evaluate the performance and absorption of OX640 in participants suffering from allergic rhinitis, commonly known as hay fever.

The research underway involves 30 participants in a cross-over study that includes four distinct treatment periods. During one period, a small dose of an allergen will be introduced into the participants’ noses to incite an allergic reaction before administering OX640. This will be compared against administering OX640 without prior allergen exposure, the use of a commercial intramuscular epinephrine product, and documenting the dose proportionality of OX640. Key metrics, such as the absorption of epinephrine and its effects on blood pressure and heart rate, will be measured to understand the drug's efficacy under various conditions.

The study, named OX640-002, is crucial as it explores the absorption of epinephrine from OX640 in conditions where allergic symptoms are present in the nose, a scenario that can occur during anaphylaxis. This aspect of the study addresses significant development and regulatory requirements and is vital for progressing OX640 towards eventual regulatory approval. Orexo’s SVP and Head of R&D, Robert Rönn, highlighted the importance of ensuring OX640's effectiveness even when nasal allergic symptoms are present, noting that this has been a recurring topic in discussions with healthcare providers and potential partners.

The financial investment for this study is estimated at SEK 11 million, with most of the costs being accounted for in 2024. Orexo has included these expenses in its financial outlook for the year. The results from this study are anticipated to be available early in 2025, providing critical insights into the practicality and effectiveness of OX640 for patients who might experience severe allergic reactions.

AmorphOX, the drug delivery platform underpinning OX640, utilizes a unique combination of drug, carrier materials, and other ingredients to form a powder with excellent stability and rapid dissolution properties. This platform is versatile and has been validated in various human clinical studies, demonstrating rapid and extensive drug exposure.

Orexo’s commitment to advancing pharmaceuticals that address significant medical needs is evident in their continuous research and development efforts. With over three decades of experience, the company has developed and commercialized products targeting various therapeutic areas, including innovative solutions for opioid use disorder. Orexo’s presence in the U.S. market and collaborations with leading partners worldwide highlight its ongoing contribution to improving patient health outcomes.

OX640’s development represents a significant step forward in providing a needle-free, convenient, and rapidly acting solution for severe allergic reactions. Its potential for long shelf-life and flexible storage further underscores its suitability for varied environmental conditions, catering to patients' needs more efficiently.

Overall, the current study on OX640 aims to consolidate its effectiveness and safety profile, paving the way for its regulatory approval and subsequent availability to patients in need of a reliable emergency allergy treatment.