LONDON and NEW YORK, Nov. 6 /PRNewswire/ -- Morria Biopharmaceuticals Plc, a biopharmaceutical company focused on novel, anti-inflammatory drugs, today announced positive data from its ICH compliant Phase II equivalent multi-center study of MRX-4 (n=105) in patients suffering from allergic rhinitis. MRX-4 was given as an intranasal spray formulation.
The Nasal Allergen Challenge (NAC) 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(R) (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 (PK) 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 (chi-test) demonstrated a statistically significant (p < 0.01) therapeutic effect versus placebo. In addition, no serious adverse effects (SAEs) were noted and the drug was not detected in patients' serum (PK).
"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," said Morria president, Yuval Cohen. "This is a potent indication that MRX-4 functions as an intra-nasal anti-inflammatory drug for allergic rhinitis."
Morria recently reported the positive results regarding MRX-4 modulating the levels of inflammatory mediators (IL-5, IL-13, MCP-1, TNF-alpha and Eotoxin) as well as eosinophils in the nasal lavage from the same study.
"The results of the ICH compliant Phase II equivalent study represent a
|SOURCE Morria Biopharmaceuticals Plc|
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