Orexo has announced that the first participants have been dosed with OX640, an intranasal rescue medication designed for severe allergic reactions, including anaphylaxis, using powder-based epinephrine.
The study, OX640-002, focuses on subjects with allergic rhinitis (hay fever) and will be completed in 2024, with results expected in early 2025.
Orexo, a Swedish pharmaceutical company, is advancing the development of OX640 following positive results from the Phase 1 clinical study OX640-001.
This study demonstrated that the intranasal rescue medication absorbs epinephrine and has similar effects on blood pressure and heart rate equivalent to an epinephrine intramuscular auto-injector.
In OX640-002, researchers will investigate the absorption of epinephrine in participants with and without nasal allergic symptoms in the nose.
Understanding this absorption of epinephrine from Orexo’s powder formulation is crucial, as patients may experience nasal symptoms during anaphylaxis.
The study is a cross-over design involving 30 participants with allergic rhinitis and includes four treatment periods.
In one period, a small dose of an allergen will be sprayed into participants’ noses to trigger an allergic reaction before treatment with nasal medication.
This will be compared to the absorption of epinephrine from OX640 without the allergen and a commercial intramuscular epinephrine product.
The fourth period will assess the dose proportionality of OX640. Alongside epinephrine absorption, the study will measure blood pressure and heart rate to evaluate OX640’s effects during anaphylaxis.
Orexo R&D senior vice president and head Robert Rönn said: “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.”
OX640 utilises Orexo’s proprietary AmorphOX drug delivery platform, which ensures rapid systemic drug absorption after nasal administration, along with physical and chemical stability.
AmorphOX consists of particles made from a blend of a drug, carrier materials, and optional ingredients.
In February this year, the Swedish pharmaceutical company and Swedish Orphan Biovitrum (Sobi) partnered to advance an exploratory feasibility study with the AmorphOX platform.
Last year, Orexo announced that its New Drug Application (NDA) for OX124 was accepted for review by the US Food and Drug Administration (FDA). OX124 is a nasal rescue medication designed for opioid overdose.
