Orexo to present clinical data for OX640 at the EAACI Congress

Rhea-AI Summary

Orexo (ORXOY) announced its participation in the 2025 EAACI Congress in Glasgow, where clinical data for OX640, their nasal rescue medication for severe allergic reactions, will be presented. Dr. Anne K Ellis from Queen's University will present findings from the OX640-002 study on June 15, which showed significantly faster epinephrine absorption under allergic rhinitis conditions. The powder-based epinephrine treatment, utilizing Orexo's proprietary AmorphOX technology, demonstrated promising results for rapid onset of action in patients with airway symptoms. Additionally, SVP and Head of R&D Robert Rönn will present a poster showcasing OX640's stability data, expressing confidence in the product's potential as a convenient and reliable rescue medication for severe allergic reactions.

Positive

• Clinical study OX640-002 showed significantly faster epinephrine absorption under allergic rhinitis conditions
• Product demonstrates promising stability data profile
• Technology shows potential for rapid onset of action in patients with airway symptoms

Negative

• None.

• OX640 is a nasal rescue medication with powder-based epinephrine for the treatment of severe allergic reactions (including anaphylaxis) and is based on the proprietary AmorphOX® technology
• EAACI is a leading global association devoted to allergic and immunology diseases
• Orexo´s advisor Dr. Anne K Ellis, Professor and Chair of the Division of Allergy & Immunology at Queen's University, Ontario, CA, will present data from the OX640-002 clinical study.

UPPSALA, Sweden, June 2, 2025 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), announces the company will attend the 2025 EAACI Congress in Glasgow, UK, on June 13-16. The European Academy of Allergy and Clinical Immunology (EAACI) is a leading global association for the treatment of allergic and immunology diseases, including members representing over 16,000 clinicians, researchers, and health professionals from 125 countries.

On June 15, Dr. Anne K. Ellis, Professor and Chair of the Division of Allergy & Immunology at Queen's University (Kingston, Ontario, Canada) and advisor to Orexo will present on behalf of the company. Dr. Anne K. Ellis will present data from the OX640-002 clinical study, which, among other findings, demonstrated that epinephrine was absorbed significantly faster under allergic rhinitis conditions compared to normal conditions. These results support a rapid onset of action, even in patients experiencing airway symptoms.

In addition to the oral presentation, Orexo's SVP and Head of R&D, Robert Rönn, will present a scientific poster demonstrating detailed stability data for OX640.

"We look forward to attending this important congress. Thanks to our powder-based drug-delivery technology, AmorphOX®, we are able to present strong data from the second clinical study of OX640, along with a leading stability profile. I am confident that OX640 has the potential to become a convenient, effective, and reliable rescue medication for people at risk of severe allergic reactions," said Robert Rönn, SVP and Head of R&D.

For further information contact:
Nikolaj Sørensen, President and CEO
Lena Wange, IR & Communications Director
+46 (0)18 780 88 00
ir@orexo.com

About Orexo

Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs.
On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2024 amounted to SEK 590 million, and the number of employees 110. Orexo is listed on Nasdaq Stockholm's main list and is available as ADRs (ORXOY) on the OTCQX market in the US.

For more information on Orexo, visit www.orexo.com. You can also follow Orexo on X, LinkedIn, and YouTube.

About AmorphOX^® 

Orexo's proprietary drug-delivery platform, AmorphOX, is a powder made up of particles that are built using a unique combination of a drug, carrier materials and, optionally, other ingredients.
The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure. 

About OX640

OX640 is a nasal epinephrine powder-based product for the acute treatment of severe allergic reactions, including anaphylaxis. The product is based on the proprietary AmorphOX drug-delivery platform providing rapid and extensive systemic drug absorption after nasal administration as well as excellent physical and chemical stability. Thanks to its unique properties, OX640 has the potential to provide allergic patients with a needle-free, convenient, and rapidly acting allergy rescue product that also has a long shelf-life and allows for flexible storage, both in hot and cold temperatures.

About the OX640-002 study

The study was a 4-period cross-over study in 30 otherwise healthy subjects with seasonal allergic rhinitis. The study was conducted during allergy season with no ongoing allergy symptoms in subjects. Epinephrine plasma levels, blood pressure and heart rate were collected after administration of two different doses of OX640 and 0.3 mg intramuscular epinephrine. In one treatment period, one of the OX640 doses was administered following nasal administration of allergens, producing acute allergic rhinitis symptoms in the subjects.

#EAACI2025 #TogetherForAllergy

The information was submitted for publication at 8.00 am CET on June 2, 2025. 

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https://mb.cision.com/Public/694/4157914/bfa52c641a0f7a55.pdf

Orexo PR Orexo to present clinical data for OX640 at the EAACI Congress Publ June 2

 

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SOURCE Orexo

FAQ

What are the key findings of Orexo's OX640-002 clinical study for ORXOY stock?

The study showed that epinephrine was absorbed significantly faster under allergic rhinitis conditions compared to normal conditions, supporting rapid onset of action in patients with airway symptoms.

What is Orexo's OX640 drug and what is it used for?

OX640 is a nasal rescue medication containing powder-based epinephrine, based on AmorphOX technology, designed for treating severe allergic reactions including anaphylaxis.

When and where will Orexo present the OX640 clinical data?

Orexo will present the OX640 clinical data at the 2025 EAACI Congress in Glasgow, UK, on June 15, 2025.

Who will present Orexo's OX640 clinical data at EAACI?

Dr. Anne K Ellis, Professor and Chair of the Division of Allergy & Immunology at Queen's University, will present the clinical data on behalf of Orexo.

What technology does Orexo's OX640 use?

OX640 uses Orexo's proprietary AmorphOX technology, which enables a powder-based epinephrine delivery system for nasal administration.