Orexo Phase IIa allergic rhinitis trial fails endpoint

The program is intended to produce therapeutic molecules for the treatment of inflammatory airway diseases including rhinitis, asthma and chronic obstructive pulmonary disease (COPD).

The trial data showed that treatment with 15mg or 50mg per day of OX914 did not show a statistically significant reduction in patient symptom scores after allergen provocation, compared with placebo treatment. OX914 was safe and well-tolerated and, unlike most other phosphodiesterase 4 (PDE4) inhibitors, did not show any increased evidence of nausea or vomiting compared with placebo, the company said.

While this result shows that oral treatment with OX914 is not likely to be an effective therapy in allergic rhinitis, no assessment can be made from this result in respect of its efficacy against COPD.

In light of the preclinical in vivo evidence of efficacy and the molecule’s strong safety and tolerability profile, Orexo said that it will continue its ongoing discussions with several potential development partners for OX914 and the suite of back-up molecules in this series for COPD and other non-respiratory inflammatory indications.

Charlotte Edenius, chief scientific officer and head of preclinical R&D at Orexo, said: “Although we are disappointed that the lead molecule did not meet its primary endpoint after oral treatment in this rhinitis study, we remain confident that the PDE4 program contains very potent and targeted inhibitors of PDE4, a clinically validated target for both COPD and asthma. We will continue with our partnering discussions for OX914 and the program for various inflammatory indications.”