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Orexo to present clinical data for OX640 at the EAACI Congress

MWN-AI** Summary

Orexo AB is poised to present significant clinical findings related to OX640, its innovative nasal rescue medication for severe allergic reactions, including anaphylaxis, at the 2025 EAACI Congress in Glasgow, UK, from June 13-16. The European Academy of Allergy and Clinical Immunology (EAACI) is a premier global organization dedicated to exploring advancements in allergic and immunological diseases, comprising over 16,000 professionals from 125 countries.

Dr. Anne K. Ellis, a prominent figure in allergy and immunology from Queen's University in Canada, will present data from the OX640-002 clinical study on June 15. This study highlights that epinephrine was absorbed significantly faster in conditions mimicking allergic rhinitis compared to normal circumstances, indicating a rapid onset of action which is crucial during acute allergic episodes. Additionally, Orexo's Senior Vice President of R&D, Robert Rönn, will provide a scientific poster showcasing the drug's stability data.

OX640 is developed using Orexo's proprietary AmorphOX® technology, facilitating rapid systemic drug absorption through nasal administration while allowing for excellent chemical and physical stability. These characteristics could make OX640 a game-changer in emergency treatment, offering a needle-free and easy-to-store alternative that maintains efficacy in a range of temperatures.

The OX640-002 clinical study involved 30 healthy subjects with seasonal allergic rhinitis, assessing the pharmacokinetics of OX640 compared to traditional intramuscular epinephrine. With total net sales in 2024 reaching SEK 590 million, Orexo's commitment to enhancing patient treatment options, particularly for those at risk of severe allergic reactions, signals its growing footprint in the pharmaceutical industry.

MWN-AI** Analysis

Orexo AB's recent announcement regarding the presentation of clinical data for OX640 at the upcoming EAACI Congress is significant for investors focused on biotech and pharmaceutical sectors. OX640, a nasal rescue medication leveraging the innovative AmorphOX® technology, aims at providing a fast-acting solution for severe allergic reactions, including anaphylaxis. The clinical data being presented is particularly encouraging, showcasing that epinephrine absorption is notably quicker under allergic conditions, which could enhance its efficacy in emergency situations.

As Orexo provides robust clinical evidence supporting the rapid onset of OX640, it could drive increased interest among healthcare providers and investors alike. The presentation at EAACI, an esteemed forum attracting global experts in allergy and immunology, amplifies the visibility of OX640, potentially influencing adoption trends and market perception. The accumulating data from the OX640-002 study, demonstrating favorable pharmacokinetics compared to traditional delivery methods, could position Orexo favorably against competitors offering injectable alternatives.

Investors should pay attention to Orexo's strategic advancements in the allergy treatment market, which are underscored by favorable clinical outcomes and the convenience of a needle-free product. Given the global prevalence of severe allergies and the increasing demand for innovative solutions in this space, Orexo is well-positioned to capture significant market share if OX640 receives regulatory approval and successfully penetrates the market.

To capitalize on this growth potential, investors may consider maintaining or increasing their holdings in Orexo leading up to and following the EAACI Congress, particularly in light of the promising data presentation. However, it is prudent to remain aware of market fluctuations and regulatory timelines that may impact the company’s stock performance.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: PR Newswire

PR Newswire

  • 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.

This information was brought to you by Cision http://news.cision.com

The following files are available for download:

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

SOURCE Orexo

FAQ**

What specific results from the OX640-002 clinical study will Dr. Anne K. Ellis highlight at the EAACI Congress, and how might these findings impact the perception of the powder-based nasal epinephrine product, Orexo AB ADR ORXOY?

Dr. Anne K. Ellis will highlight the efficacy and safety results of the OX640-002 study, potentially enhancing the perception of Orexo AB's powder-based nasal epinephrine product by demonstrating its convenience and effectiveness as an alternative to traditional delivery methods.

Given the faster absorption of epinephrine under allergic rhinitis conditions observed in the OX640-002 study, what implications does this have for the potential efficacy of OX640 in real-world scenarios, particularly for Orexo AB ADR ORXOY?

The faster absorption of epinephrine under allergic rhinitis conditions suggests that OX640 may provide quicker and potentially more effective relief in real-world scenarios, enhancing Orexo AB's position in the market and potentially boosting the performance of ORXOY.

How do the stability data presented in the scientific poster complement the findings from the OX640-002 clinical study, and what advantages does this present for the commercial viability of OX640 by Orexo AB ADR ORXOY?

The stability data enhances the OX640-002 clinical study findings by demonstrating consistent efficacy and safety, thereby reinforcing OX640’s commercial viability for Orexo AB (ADR ORXOY) through increased investor confidence and potential market demand.

What feedback does Orexo anticipate from the allergy and immunology community at the EAACI Congress regarding OX640, and how will this influence the future development strategy for Orexo AB ADR ORXOY?

Orexo anticipates receiving valuable feedback from the allergy and immunology community at the EAACI Congress regarding OX640, which will inform its future development strategy for Orexo AB ADR (ORXOY) by potentially shaping clinical focus and market positioning.

**MWN-AI FAQ is based on asking OpenAI questions about Orexo AB ADR (OTC: ORXOY).

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