Results from ICH compliant Phase II study of MRX-4 presented at EAACI Congress

Jun 16 2010

Morria Biopharmaceuticals Plc, a biopharmaceutical company focused on novel, anti-inflammatory drugs, announced today the results from its ICH compliant Phase II study of MRX-4>th EAACI Congress (European Academy of Allergy and Clinical Immunology) in London. The study's principal investigators were Drs. Eric Bateman, Mary Bateman and Paul Potter.

“I look forward to the next clinical study and to further investigating the clinical potential of this drug.”

Study design: the Nasal Allergen Challenge (NAC) study was conducted in allergic rhinitis patients outside of the local allergy season. The double blind placebo-controlled 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. A separate single blind placebo controlled intranasal steroid arm was also carried out using a budesonide nasal spray.

Study endpoints: The primary objective of the study was to assess safety by examining usual clinical, physiological and biochemical measures. The secondary end-points of the study were (1) levels of inflammatory mediators (IL-5, IL-13, MCP-1, TNF-alpha, IL-8 and Eotoxin) as well as eosinophils in the nasal lavage and (2) assessment of clinical symptoms of rhinorrhea, nasal itching, sneezing, frontal headache, nasal congestion and ear/palatal itching.

Results: The study achieved its primary and secondary objectives. MRX-4 was well tolerated and safe with treatment emergent adverse events being similar in Control and MRX-4 groups. MRX-4 reduced eosinophil numbers, and levels of IL-5, IL-13, eotaxin, MCP-1 and TNF-alpha in nasal lavage fluid were lower during NAC compared to Control. Subjects treated with MRX-4 recorded fewer clinical symptoms than those in the Control group. In particular, MRX-4 significantly reduced symptoms of nasal congestion and frontal headaches, symptoms associated with the late phase of the allergic response that are responsive to controller treatments like corticosteroids.

This favourable safety profile coupled with supportive preliminary efficacy data provides grounds for optimism that MRX-4 will be a useful addition to the class of controller therapies for allergic rhinitis. "For a first-in-patient study in rhinitis, these are promising results," said Dr. Eric Bateman. "I look forward to the next clinical study and to further investigating the clinical potential of this drug."

The study was supported by the Flight Attendants Medical Research Institute (FAMRI).