The nasal allergen challenge study was conducted in allergic rhinitis patients outside of the local allergy season. MRX-4 was compared with both placebo (arm 1) and an intranasal steroid Rhinocort (as a positive control, arm 2).
Arm 1 of the study consisted of a six-day, twice-daily intranasal administration of placebo or MRX-4 followed by an intranasal dose of allergen on the morning of the seventh day with a clinical follow-up and scoring over the next 24 hours. Blood, urine and pharmacokinetics analyses were also conducted.
MRX-4 efficacy was assessed by its reduction of six clinical categories: rhinorrhea, nasal itching, sneezing, frontal headache, nasal congestion and ear/palate itching. Multivariate analysis demonstrated a statistically significant (p < 0.01) therapeutic effect versus placebo. In addition, no serious adverse effects were noted and the drug was not detected in patients' serum. Yuval Cohen, president of Morria, said: "The clinical data demonstrates that MRX-4 has a statistically significant effect on several key symptom categories of allergic rhinitis: it correlates nicely with the nasal lavage inflammatory marker data. This is a potent indication that MRX-4 functions as an intra-nasal anti-inflammatory drug for allergic rhinitis."