Orexo announces positive topline data from clinical study of OX640 in subjects with and without allergic rhinitis
Orexo AB (STO: ORX, OTCQX: ORXOY) announced positive topline results from clinical study OX640-002, evaluating their nasal rescue medication OX640, a powder-based epinephrine treatment for allergic reactions including anaphylaxis. The cross-over study involved 30 subjects and compared two doses of OX640 against an intramuscular injection reference product.
Key findings showed that OX640 treatments achieved clinically relevant epinephrine plasma levels faster than the intramuscular reference. Notably, absorption was significantly faster under allergic rhinitis conditions compared to normal conditions, demonstrating efficacy in patients with airway symptoms. The treatment produced more pronounced increases in blood pressure and heart rate compared to intramuscular injection. Safety profiles aligned with known epinephrine pharmacology, with only transient and tolerable local effects reported.
Orexo AB (STO: ORX, OTCQX: ORXOY) ha annunciato risultati positivi dalle prime analisi dello studio clinico OX640-002, che valuta il loro farmaco nasale di emergenza OX640, un trattamento a base di polvere di epinefrina per reazioni allergiche, inclusa l'anaphylassi. Lo studio incrociato ha coinvolto 30 soggetti e ha confrontato due dosi di OX640 con un prodotto di riferimento somministrato tramite iniezione intramuscolare.
I risultati principali hanno mostrato che i trattamenti con OX640 hanno raggiunto livelli plasmatici di epinefrina clinicamente rilevanti più rapidamente rispetto al riferimento intramuscolare. In particolare, l'assorbimento è stato notevolmente più veloce in condizioni di rinite allergica rispetto a quelle normali, dimostrando l'efficacia nei pazienti con sintomi respiratori. Il trattamento ha prodotto aumenti più marcati della pressione sanguigna e della frequenza cardiaca rispetto all'iniezione intramuscolare. I profili di sicurezza erano in linea con la farmacologia nota dell'epinefrina, e sono stati segnalati solo effetti locali transitori e tollerabili.
Orexo AB (STO: ORX, OTCQX: ORXOY) anunció resultados positivos preliminares del estudio clínico OX640-002, que evalúa su medicamento nasal de rescate OX640, un tratamiento a base de epinefrina en polvo para reacciones alérgicas, incluida la anafilaxis. El estudio cruzado involucró a 30 sujetos y comparó dos dosis de OX640 con un producto de referencia administrado por inyección intramuscular.
Los hallazgos clave mostraron que los tratamientos con OX640 lograron niveles plasmáticos de epinefrina clínicamente relevantes más rápidamente que el producto de referencia intramuscular. Notablemente, la absorción fue significativamente más rápida en condiciones de rinitis alérgica en comparación con las normales, demostrando eficacia en pacientes con síntomas respiratorios. El tratamiento produjo aumentos más pronunciados en la presión arterial y la frecuencia cardíaca en comparación con la inyección intramuscular. Los perfiles de seguridad estaban alineados con la farmacología conocida de la epinefrina, reportando solo efectos locales transitorios y tolerables.
Orexo AB (STO: ORX, OTCQX: ORXOY)는 알레르기 반응, 특히 아나필락시스에 대한 파우더 기반 에피네프린 치료제 OX640의 임상 연구 OX640-002의 긍정적인 초기 결과를 발표했습니다. 이 교차 연구에는 30명이 참여했으며 OX640의 두 가지 용량을 근육 주사(reference product)와 비교했습니다.
주요 결과는 OX640 치료가 근육 주사(reference)보다 임상적으로 중요한 에피네프린 혈장 수치를 더 빠르게 도달했다는 점입니다. 특히, 알레르기 비염 상태에서의 흡수는 일반적인 상태보다 현저히 빠른 것으로 나타나 환기의 증상이 있는 환자들에게 효과적임을 보여주었습니다. 이 치료는 근육 주사에 비해 혈압과 심박수의 더 뚜렷한 증가를 가져왔습니다. 안전성 프로필은 알려진 에피네프린 약리학과 일치했으며, 오직 일시적이고 용인 가능한 국소적인 효과만 보고되었습니다.
Orexo AB (STO: ORX, OTCQX: ORXOY) a annoncé des résultats préliminaires positifs de l'étude clinique OX640-002, évaluant leur médicament nasal de secours OX640, un traitement à base d'épinéphrine en poudre pour les réactions allergiques, y compris l'anaphylaxie. L'étude croisée a impliqué 30 sujets et a comparé deux doses de OX640 à un produit de référence administré par injection intramusculaire.
Les résultats clés ont montré que les traitements par OX640 ont atteint des niveaux plasmatiques d'épinéphrine cliniquement pertinents plus rapidement que le produit de référence intramusculaire. Notamment, l'absorption était significativement plus rapide dans des conditions de rhinite allergique par rapport à des conditions normales, montrant une efficacité chez les patients présentant des symptômes respiratoires. Le traitement a entraîné des augmentations plus marquées de la pression artérielle et de la fréquence cardiaque par rapport à l'injection intramusculaire. Les profils de sécurité étaient conformes à la pharmacologie connue de l'épinéphrine, avec seulement des effets locaux transitoires et tolérables signalés.
Orexo AB (STO: ORX, OTCQX: ORXOY) gab positive vorläufige Ergebnisse aus der klinischen Studie OX640-002 bekannt, die ihr nasales Notfallmedikament OX640, eine pulverbasierte Epinephrin-Behandlung für allergische Reaktionen, einschließlich Anaphylaxie, bewertet. Die Kreuzstudie umfasste 30 Probanden und verglich zwei Dosen von OX640 mit einem intramuskulären Referenzprodukt.
Wichtige Ergebnisse zeigten, dass OX640-Behandlungen klinisch relevante Plasmaspiegel von Epinephrin schneller erreichten als die intramuskuläre Referenz. Besonders bemerkenswert war, dass die Absorption unter Bedingungen der allergischen Rhinitis deutlich schneller war als unter normalen Bedingungen, was die Wirksamkeit bei Patienten mit Atemwegssymptomen unter Beweis stellte. Die Behandlung führte im Vergleich zur intramuskulären Injektion zu ausgeprägteren Erhöhungen des Blutdrucks und der Herzfrequenz. Die Sicherheitsprofile stimmten mit der bekannten Pharmakologie von Epinephrin überein, wobei nur vorübergehende und tolerable lokale Effekte berichtet wurden.
- OX640 achieved faster clinically relevant plasma levels compared to intramuscular injection
- Enhanced absorption rate during allergic rhinitis conditions
- More pronounced therapeutic effects (blood pressure and heart rate) versus intramuscular injection
- No severe or serious adverse events reported
- Study results enable final commercial formulation and dose selection
- None.
- OX640 is a nasal rescue medication with powder-based epinephrine for the treatment of allergic reactions (incl. anaphylaxis) and is based on the proprietary AmorphOX® technology.
- The clinical study, OX640-002, evaluated both pharmacokinetic and pharmacodynamic effects of OX640 in subjects with and without allergic rhinitis.
- OX640 treatments achieved clinically relevant plasma levels of epinephrine more rapidly than the intramuscular reference product.
- Absorption from OX640 under allergic rhinitis conditions was significantly faster than under normal conditions, supporting rapid onset of effect also in patients with airway symptoms.
UPPSALA, Sweden, Jan. 10, 2025 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces positive topline results from the clinical study OX640-002. The study evaluated the performance in subjects with and without allergic rhinitis when treated with Orexo´s nasal rescue medication including powder-based epinephrine, OX640.
The study was a cross-over study in 30 subjects assessing absorption and pharmacodynamic effects of epinephrine from two doses of OX640, with one of the doses also administered during ongoing allergic rhinitis symptoms. Exposure was compared to a commercial intramuscular injection.
Topline data analysis demonstrates that OX640 treatments achieved mean epinephrine plasma levels associated with clinical efficacy more rapidly than the intramuscular injection, with dose-dependent exposure levels. Absorption under allergic rhinitis conditions was significantly faster than under normal conditions, supporting rapid onset of effect also in patients with significant airway symptoms. OX640 formulations typically produced more pronounced increases in blood pressure and heart rate than the intramuscular injection, which are key effects for treatment of anaphylaxis.
Systemic safety was in line with the known pharmacology of epinephrine and local effects were transient and tolerated. There were no severe or serious adverse events.
Robert Rönn, SVP and Head of R&D, said: "We are pleased with the outcome of the study which further support the utility of our OX640 epinephrine nasal powder for treatment of anaphylaxis, even in case of allergic rhinitis symptoms. Importantly, the study results allow us to decide on the final commercial formulation and dose, which is critical to advance the project towards regulatory approval. The data further reinforces our view that OX640 has the potential to be a unique and differentiated needle-free epinephrine product."
For further information please contact:
Nikolaj Sørensen, President and CEO
Lena Wange, IR & Communications Director
Robert Rönn, SVP and Head of R&D
Tel: +46 (0)18 780 88 00
E-mail: 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 U.S. 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 2023 amounted to
For more information on Orexo, visit www.orexo.com. Follow Orexo on X, LinkedIn, and YouTube.
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 study OX640-002
The study was a 4-period cross-over study in 30 otherwise healthy subjects with seasonal allergic rhinitis. The study was conducted off 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.
The information was submitted for publication at 2.00 pm CET on January 10, 2025.
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SOURCE Orexo
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