Morria Biopharmaceuticals Plc Announces The Initiation Of A Phase II Clinical Multi-dose Study Of MRX-4 In Allergic Rhinitis

Main Category: Allergy
Also Included In: Ear, Nose and Throat;  Clinical Trials / Drug Trials
Article Date: 25 Jun 2008 - 2:00 PDT

email to a friend   printer friendly   opinions  

Morria Biopharmaceuticals Plc, a biopharmaceutical company focused on the development of novel anti-inflammatory drugs, today announced that it has initiated a Phase II equivalent study of MRX-4, in a nasal aerosol formulation, in 105 patients suffering from allergic rhinitis (AR). The two-arm, randomized, multi-dose, double-blind, placebo-controlled study includes Rhinocort(R) as the steroid comparator arm. The study is expected to be completed by the end of Q3 2008.

The study is designed to evaluate the safety, tolerability, and efficacy of intranasal MRX-4 in AR patients outside of the local 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 has generated promising pre-clinical efficacy data. In a Phase I equivalent trial completed in Israel earlier this year, it was shown to be well tolerated with no clinical significant adverse effects.

"We are excited about the opportunity to evaluate the safety and efficacy of MRX-4 in a multi-dose trial for treating allergic rhinitis," said Mark Cohen, chairman of the board of Morria. "MRX-4 could provide unique, non-steroidal, first-choice drug treatment for allergic rhinitis."

According to Dr. Yuval Cohen, Morria's president, it is rare for a first-in-man efficacy study in AR (phase II) to include a steroid comparator arm. "Most companies prefer waiting until they have generated substantial clinical efficacy data comparing their drug to a placebo before venturing to compare it to a standard market treatment, such as a nasal corticosteroid. Our decision to include the steroid comparator arm so early in our clinical development is a combination of our confidence in MRX-4's performance as well as the creativity of our clinical team in streamlining and maximizing the efficacy of our clinical development program. We believe that this will substantially increase the value of this data."

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 US$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 US$20 billion anti-inflammatory drug market by developing and commercializing novel drugs for acute pulmonary and gastro-intestinal inflammatory diseases.

Morria Biopharmaceuticals Plc

• Additional
• References
• Citations