Orexo announces the initiation of the OX640-002 trial of OX640 epinephrine nasal powder in people with allergic rhinitis, with results expected in early 2025. The new trial is expected to enroll 30 people with allergic rhinitis and includes a test with a nasal allergen introduced prior to the epinephrine in order to compare the absorption of epinephrine with and without nasal allergy symptoms.
In October 2022, the company announced positive results from the Phase 1 OX640-001 study of OX640, which demonstrated that the nasal powder could achieve epinephrine plasma levels comparable to EpiPen. Orexo is developing OX640, which is based on its AmorphOx technology, as a rescue treatment for anaphylaxis and other severe allergic reactions.
Orexo Senior VP and Head of R&D Robert Rönn commented, “Anaphylaxis is a serious and life-threatening condition, making it essential to ensure that OX640 remains effective even in the presence of nasal allergic symptoms. The study addresses key development and regulatory requirements and is an important step in advancing the project towards regulatory approval. The performance of OX640 under allergic rhinitis conditions has also been requested in many discussions with health care providers and with potential partners.”
Read the Orexo press release.