Evolutec confirms protocol was correct in failed Ph IIb allergy trial

UK biopharmaceutical firm Evolutec says that its quality assurance review of the unsuccessful Phase IIb study of rEV131 in the treatment of allergic rhinitis confirmed that the drug and protocol were as specified in the original trial design (Marketletter December 4).

Evolutec said that patients who enrolled in the assessment were exposed to levels of ragweed pollen that were substantially higher than those used in previous trials. The firm went on to say that participants had showed around twice the allergic symptom score that was displayed in prior assessments, and added that the lack of efficacy may have been due to the greater quantity of histamine that was released, exceeding the binding capacity of the drug. The group said that it has no plans to "make further investment in rEV131 in allergic rhinitis."

Evolutec also said that the ongoing Phase II trial of rEV131 as a treatment for post-cataract surgery inflammation is expected to report early next year.