Morria Biopharmaceuticals Plc Announces Positive Clinical Results For MRX-4 In Its Phase II Clinical Study In Allergic Rhinitis Patients

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 morria.



Morria Biopharmaceuticals Plc

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