Evolutec / recomb. tick saliva PII from yesterday -
POSITIVE PHASE II CLINICAL RESULT FOR rEV131 IN SEASONAL ALLERGIC RHiNITIS (HAY FEVER)
Trial meets primary endpoint; rEV131 shows efficacy and rapid onset of action Conference call for analysts today at 3pm BST
Evolutec Group plc (AIM: EVC), the biopharmaceutical company developing novel products for the treatment of allergic, inflammatory and autoimmune diseases, is pleased to announce, ahead of schedule, a positive clinical trial result for its lead molecule, rEV131, in a 112 patient Phase II study in allergic rhinitis (hay fever).
rEV131 is a recombinant version of a naturally occurring molecule identified in ticks, parasites whose saliva contains immuno-suppressive and immuno-modulatory molecules over which Evolutec has strong patent protection.
This Phase II dose-ranging nasal allergen challenge study of rEV131 administered as a nasal spray was undertaken at two centres in San Antonio, Texas, under the leadership of Dr Paul Ratner. The trial was conducted in accordance with the Food & Drug Administration's Guidance for Industry recommendations.
The trial comprised four cohorts of 20 patients (16 active, 4 placebo), with the active patients on ascending single doses of rEV131, followed by a fifth cohort of 32 patients (16 active, 16 placebo) at the optimum dose. The ragweed pollen extract was administered 30 minutes after dosing.
The trial met its primary endpoint, a statistically significant difference (p< 0.05) in the mean sum of symptom scores at 15 minutes post allergen challenge in the 62 patients who completed the trial according to the protocol. rEV131 showed a dose dependent drug effect enabling Evolutec to select the optimum dose for further work to determine the onset of action and the duration of effect. There were no significant adverse events and rEV131 was comfortable and well-tolerated.
This result shows that rEV131 has an onset of action of 45 minutes or less - quicker than steroid nasal sprays which have an onset of action of approximately 8 hours. The main effects of rEV131 were against congestion and mucus production, symptoms that patients find the most troublesome and which are not well addressed by oral antihistamines. The rapid onset of action and efficacy against congestion and mucus underpin the potential commercial advantages of rEV131.
Mark Carnegie Brown, Evolutec's Chief Executive Officer, commented: 'This result highlights the potential of rEV131 in the $6 billion allergic rhinitis market. We now intend to undertake a multi-dose Phase II study to define further the onset and duration of action which will guide commercial positioning. We will also continue our dialogue with potential partners.'
Dr. Paul Ratner, principal study investigator and Fellow of the American Academy of Asthma, Allergy & Immunology, commented: 'I am excited about the prospect of a novel therapeutic agent for the treatment of allergic rhinitis that is safe, effective within 45 minutes and delivered via the intranasal route.'...
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