Morria Reports Encouraging Results From Phase II Allergic Rhinitis Study
Morria Biopharmaceuticals, a developer of novel, anti-inflammatory drugs, has announced the preliminary results from its recently completed Phase II equivalent study of MRX-4, in a nasal aerosol formulation, in 105 patients suffering from allergic rhinitis.
The two-arm, randomized, multi-dose, double-blind, placebo-controlled study included Rhinocort as the steroid comparator arm. A secondary efficacy endpoint of this study was the effect of MRX-4 on inflammatory mediators or markers in the nasal lavage of selected patients following allergen stimulus. The patients were pre-treated by either a placebo or MRX-4 for seven days twice per day beforehand.
MRX-4 demonstrates an overall trend of reducing the levels of five inflammatory mediators – interleukin-5 (IL-5), IL-13, tumor necrosis factor alpha (TNF-alpha), monocyte chemoattractant protein-1 (MCP-1) and eotoxin.
These mediators have been shown to play an important role in various inflammatory diseases such as allergic rhinitis, asthma, skin and intestinal inflammation and arthritis. All have previously been shown to be modulated by MRX-4 in vitro and in vivo in preclinical models. This is the first time that such modulation has been observed in patients, the company said.
In addition, the levels of eosinophils were tested in the nasal lavage. Eosinophils are white blood cells that play a key role in the allergic response. MRX-4 reduced the levels of these cells compared to placebo-treated patients.
Yuval Cohen, president of Morria Biopharmaceuticals, said: “We are pleased by the wide range of divergent inflammatory mediators that we are modulating, several of which have been covered in the scientific literature recently. Mediators, such as IL-5, IL-13 and TNF-alpha, are currently targets of R&D in the pharmaceutical field for treating respiratory inflammatory diseases, and MRX-4 modulates them in these patients.”