Orexo initiates new study of OX640 in participants with allergic rhinitis
Orexo has initiated a new clinical study (OX640-002) for OX640, an intranasal rescue medication for severe allergic reactions using powder-based epinephrine. The study will evaluate OX640's performance in 30 participants with allergic rhinitis through a cross-over design with four treatment periods. This follows positive phase 1 results where OX640 showed comparable absorption and effects to intramuscular auto-injectors.
The study will assess epinephrine absorption with and without allergic symptoms, comparing it to a commercial intramuscular product. The study cost is estimated at SEK 11 million, with completion expected in 2024 and results in early 2025.
Orexo ha avviato un nuovo studio clinico (OX640-002) per OX640, un farmaco intranasale di soccorso per reazioni allergiche severe a base di adrenalina in polvere. Lo studio valuterà le performance di OX640 in 30 partecipanti con rinite allergica attraverso un disegno a crossover con quattro periodi di trattamento. Questo segue risultati positivi della fase 1, dove OX640 ha mostrato un'assorbimento e effetti comparabili agli auto-iniettori intramuscolari.
Lo studio valuterà l'assorbimento di adrenalina con e senza sintomi allergici, confrontandolo con un prodotto intramuscolare commerciale. Il costo dello studio è stimato in 11 milioni di SEK, con completamento previsto nel 2024 e risultati all'inizio del 2025.
Orexo ha iniciado un nuevo estudio clínico (OX640-002) para OX640, un medicamento intranasal de rescate para reacciones alérgicas severas utilizando epinefrina en polvo. El estudio evaluará el rendimiento de OX640 en 30 participantes con rinitis alérgica a través de un diseño cruzado con cuatro períodos de tratamiento. Esto sigue a resultados positivos de la fase 1, donde OX640 mostró una absorción y efectos comparables a los autoinyectores intramusculares.
El estudio evaluará la absorción de epinefrina con y sin síntomas alérgicos, comparándola con un producto intramuscular comercial. El costo del estudio está estimado en 11 millones de SEK, con finalización prevista en 2024 y resultados a principios de 2025.
Orexo는 OX640에 대한 새로운 임상 연구 (OX640-002)를 시작했습니다. OX640은 분말 형태의 에피네프린을 사용하는 중증 알레르기 반응을 위한 비강 응급 약물입니다. 이 연구는 알레르기 비염이 있는 30명의 참가자를 대상으로 한 크로스오버 디자인을 통해 OX640의 성능을 평가할 것입니다. 이는 1상 결과가 긍정적으로 나타났으며, OX640이 근육주사 자가 주입기와 유사한 흡수 및 효과를 보여주었습니다.
연구는 알레르기 증상 유무에 따른 에피네프린 흡수를 평가하여 상업적인 근육주사 제품과 비교할 것입니다. 연구 비용은 1,100만 SEK로 추정됩니다, 2024년 완료 예정이며 2025년 초에 결과가 발표될 예정입니다.
Orexo a lancé une nouvelle étude clinique (OX640-002) pour OX640, un médicament de secours intranasal pour les réactions allergiques sévères utilisant de l'épinéphrine en poudre. L'étude évaluera les performances d'OX640 chez 30 participants souffrant de rhinite allergique à travers un design croisé avec quatre périodes de traitement. Cela fait suite à des résultats positifs de la phase 1 où OX640 a montré une absorption et des effets comparables aux auto-injecteurs intramusculaires.
L'étude évaluera l'absorption d'épinéphrine avec et sans symptômes allergiques, en la comparant à un produit intramusculaire commercial. Le coût de l'étude est estimé à 11 millions de SEK, avec une conclusion prévue en 2024 et des résultats début 2025.
Orexo hat eine neue klinische Studie (OX640-002) für OX640 initiiert, ein intranasales Notfallmedikament für schwere allergische Reaktionen mit pulverbasierter Epinephrin. Die Studie wird die Leistung von OX640 bei 30 Teilnehmern mit allergischer Rhinitis durch ein Kreuzübertragungsdesign mit vier Behandlungsperioden bewerten. Dies folgt auf positive Ergebnisse der Phase 1, bei denen OX640 eine vergleichbare Absorption und Wirkung wie intramuskuläre Autoinjektoren zeigte.
Die Studie wird die Absorption von Epinephrin mit und ohne allergische Symptome bewerten und mit einem kommerziellen intramuskulären Produkt vergleichen. Die Kosten der Studie werden auf 11 Millionen SEK geschätzt, mit Abschluss im Jahr 2024 und Ergebnissen Anfang 2025.
- Previous phase 1 study showed positive results with absorption and effects equivalent to standard auto-injectors
- Study addresses key development and regulatory requirements for future approval
- Additional SEK 11 million investment required for the new study
- Results won't be available until early 2025, extending development timeline
- OX640 is an intranasal rescue medication for the treatment of severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine.
- OX640 is based on Orexo´s proprietary drug delivery platform, AmorphOX®, and has demonstrated positive data in a phase 1 clinical study in healthy volunteers.
- The new study will investigate the performance of OX640 in participants with allergic rhinitis.
UPPSALA,
Following the positive results from the phase 1 clinical study, OX640-001, where OX640 showed absorption of epinephrine and effects on blood pressure and heart rate equivalent to an epinephrine intramuscular auto-injector, Orexo now advances the development of OX640. In the new study, OX640-002, the epinephrine absorption from OX640 will be investigated in participants with and without allergic symptoms in the nose. As patients may experience allergic symptoms in the nose during anaphylaxis, it is critical to understand the absorption of epinephrine from Orexo's unique powder formulation under these conditions.
The study is a cross-over study in 30 participants with allergic rhinitis and involves four treatment periods. In one of the periods, a small dose of an allergen will be sprayed into the nose of the participants to trigger an allergic reaction before being treated with OX640. This will be compared with absorption of epinephrine from OX640 without the allergen, and a commercial intramuscular epinephrine product. The fourth period will be used to document dose proportionality of OX640. In addition to the absorption of epinephrine, effects on blood pressure and heart rate will be measured as relevant parameters to understand the effect of OX640 in case of an anaphylaxis.
Robert Rönn, SVP and Head of R&D, said: "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."
The study is expected to cost
For further information:
Robert Rönn, SVP and Head of R&D
Lena Wange, IR & Communications Director
Nikolaj Sørensen, President and CEO
Tel: +46 (0)18 780 88 00
E-mail: ir@orexo.com
About AmorphOX®
Orexo's proprietary drug delivery platform, AmorphOX, is a powder made up of particles which 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 an intranasal rescue medication for the treatment of severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine. The product is based on Orexo´s proprietary drug delivery platform AmorphOX 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 long shelf-life and allows for flexible storage, both in hot and cold temperatures.
About OX640-001
OX640-001 is a randomised sequence, single-centre, open label, 5-period crossover, phase 1 comparative bioavailability study with the primary objective to determine the relative bioavailability and absorption characteristics of four investigational formulations of OX640 versus an intramuscular auto-injector of epinephrine.
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 and adjacent diseases. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2022 amounted to
For more information about Orexo please visit, www.orexo.com. You can also follow Orexo on X, LinkedIn, and YouTube.
The information was submitted for publication at 3 pm CET on October 25, 2024.
This information was brought to you by Cision http://news.cision.com.
The following files are available for download:
https://mb.cision.com/Public/694/4056931/846c76cc14c009b4_org.png | OX640 Open vial device 1 |
https://mb.cision.com/Public/694/4056931/870104a5df4c9faa_org.png | Orexo amorphOX technology |
https://mb.cision.com/Public/694/4056931/be090a3a4f0e6805_org.png | Nasal Epinephrine Product |
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SOURCE Orexo
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