Morria Biopharmaceuticals Plc Announces Regulatory Approval To Commence Phase II Clinical Study Of MRX-4 In Allergic Rhinitis

Main Category: Allergy
Also Included In: Respiratory / Asthma;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 12 Jun 2008 - 3:00 PDT

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Morria Biopharmaceuticals Plc, a biopharmaceutical company focused on the development of novel anti-inflammatory drugs, announced that it has obtained regulatory approval from the South African Medicines Control Council (MCC) to initiate a Phase II study of MRX-4 in 105 patients suffering from allergic rhinitis (AR). The two-arm, randomized, multi-dose, double-blind, placebo-controlled study includes a steroid comparator arm.

The study will evaluate the safety, tolerability, and preliminary efficacy of intranasal MRX-4 in AR patients outside of allergy season as compared with both placebo and an intranasal steroid. An experimental multi-functional anti-inflammatory drug (MFAID), MRX-4 is a non-steroidal potential treatment for AR that was shown to be safe and well tolerated in a Phase I equivalent trial completed in Israel earlier this year.

"This study will provide valuable data regarding its potential in allergic rhinitis, including efficacy, tolerability and pharmacokinetic data," said Dr. Yuval Cohen, president of Morria. "We are excited to be taking this significant step toward testing a potentially safer, more effective, and more affordable treatment option for the significant commercial opportunity in the multi-billion dollar allergic rhinitis market".

ABOUT ALLERGIC RHINITIS

Allergic rhinitis is a common condition that affects nearly 59 million people in the United States (nearly 20 percent of the population) with a market of close to $4 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, but previously elusive anti-inflammatory drug target. At the same time, they also protect cells and tissues against inflammatory damage. Morria is determined to become a pivotal player in the $20 billion anti-inflammatory drug market by developing and commercializing novel drugs for acute pulmonary and gastro-intestinal inflammatory diseases. For more information, please visit http://www.morria.com.

This is not an invitation nor is it an offer to purchase or subscribe for shares. This release is only intended for persons falling within the exception set out in regulation 47 of the Financial Promotion order - Persons in the business of disseminating information.

Morria Biopharmaceuticals Plc
http://www.morria.com