Morria Biopharmaceuticals Plc Announces Positive Clinical Results for MRX-4 in its Phase II Clinical Study in Allergic Rhinitis Patients
LONDON and NEW YORK, November 06, 2008 /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 significant milestone for Morria in advancing its anti-inflammatory program," stated Mark Cohen, Morria chairman. "We look forward to partnering our allergic rhinitis program as well as our dermatology and inflammatory bowel disease (IBD) programs with potential companies interested in these markets as well as our platform based lipid technology."
ABOUT ALLERGIC RHINITIS
Allergic rhinitis is a common condition that affects 20%-25% of people in the industrialized world with a market of close to $10 billion. Allergic rhinitis is characterized by inflammation of the nasal membranes accompanied by symptoms that may include sneezing, nasal congestion, nasal itching and rhinorrhea.
ABOUT MORRIA BIOPHARMACEUTICALS Plc
Morria Biopharmaceuticals Plc is a biopharmaceutical company focused on the development of novel, anti-inflammatory pharmaceuticals termed multi-functional anti-inflammatory drugs (MFAIDs). This class of drugs uniquely combines two promising approaches to preventing and reversing inflammation: first, they control the phospholipase A2 (PLA2) enzyme family, a known anti-inflammatory drug target. At the same time, they also enrich the cell surface glycosaminoglycans thereby protecting the cell against inflammatory agents. Morria is determined to become a pivotal player in the anti-inflammatory drug market by developing and commercializing novel drugs for respiratory, dermatology, pulmonary, gastro-intestinal and allergic inflammatory diseases. For more information, please visit http://www.morria.com.
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Posted: November 2008