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Morria Biopharmaceuticals Plc. is a based biopharmaceutical drug development company focused on the development of novel, non-steroidal anti-inflammatory drugs.

Lead products include first-in-class, synthetic drugs termed Multi-Functional Anti-Inflammatory Drugs (MFAID). These unique drugs target a known well characterized pathway in the inflammation process, upstream of current competitors, and simultaneously protect cells and tissues against inflammatory damage.

Morria has two lead products in development: MRX-4 (allergic rhinitis) and MRX-6 (contact dermatitis) and a number of back up compounds developed from its technology platform which are in pre-clinical phase.

Morria completed a fully ICH-compliant double blind placebo controlled Phase II study in allergic rhinitis (n=105) showing promising clinical efficacy and modulation of inflammatory mediators and eosinophils in the nasal lavage of patients treated with MRX4 (a nasal spray preparation) versus placebo.

A first-in-man academic study in contact dermatitis (preliminary efficacy and tolerability) demonstrated efficacy of MRX6 (a topical cream) versus placebo. Neither study showed any serious adverse effects.

Follow-up studies are underway (academic dermatology Phase II study on n=80) and Q2 2010 (Vienna Challenge Chamber in allergic rhinitis).

Market Opportunity
Opportunities lie in three major pathology areas: inflammatory diseases of the skin (a $3 billion market), respiratory inflammatory markets (allergic rhinitis, asthma and cystic fibrosis, a combined $20 billion market) and gastro-intestinal inflammatory diseases (Inflammatory Bowel Disease, a $3 billion market).

Unmet medical need
Corticosteroids are still the preferred first-choice therapeutics in the anti-inflammatory drug market. This is due to their broad-ranged potency and the diverse routes of administration available. However, steroids have severe side-effects, providing an urgent incentive to find equivalent alternatives. Biological drugs are often prohibitively expensive and severely restricted in terms of route of administration, insurance coverage and patient population. MFAIDs possess the potential to provide said alternatives.

  • 1. MFAIDs are first-in-class products - unique and potent technology.
  • 2. MFAIDs have shown low toxicity coupled with broad-ranged efficacy confirmed by animal trials and in human clinical studies (topical and nasal).
  • 3. MFAIDs are synthetically produced and affordable to manufacture.
  • 4. Multiple administration routes available (topical, inhaled, nasal, systemic)
  • 5. Issued and pending patents and applications in the United States and worldwide covering the lead products and indications.

Morria Product Development 

Indication Name Status and Estimated Schedule
Allergic rhinitis MRX4 (nasal spray) Phase IIa (n=105) completed
Next Study: Phase II Vienna Chamber (2011)
IND Target date: 2011
Dermatology (eczema) MRX6 (topical cream) First-in-man (n=11) completed
Next Study: Phase II (n=80) underway
IND Target Date: 2011
Ophthalmology OPX1 Allergic conjunctivitis animal model completed
Next Study: Dry Eye animal model
Phase I Target Date: 2011
IBD MRX5 (oral dosing) Pre-clinical standard animal models completed
Next Study: Animal PK studies
Phase I Target Date: 2012
Cystic fibrosis CFX1 Pre-clinical screening completed
Next Study: Pre-clinical toxicology and formulation
Phase I Target Date: 2012

Respiratory inflammatory diseases (Allergic Rhinitis, Asthma & COPD)

  • Morria's MFAIDs uniquely target key events in respiratory inflammation. MFAIDs have shown promising efficacy in animal studies exhibiting preventer-like drug functionality and an unexpected reliever-like functionality.
  • MFAIDs could offer patients the convenience and potency of the best current treatments without the usual severe side effects at an affordable price.
  • MFAIDs are administered by an inhaler (asthma) or nasal spray (allergic rhinitis).
  • Phase I and II were successfully completed with no SAEs and with excellent blood and PK safety profiles.MRX-4 showed statistically significant clinical efficacy versus placebo in the fully ICH-compliant Phase II study (n=105) and reduced levels of inflammatory mediators and eosinophils in the nasal lavage.

Inflammatory skin diseases (dermatitis)

  • Morria's MFAIDs target inflammatory mediators that play a key role in skin inflammation.
  • MFAIDs potentially offer efficacy and safety which are currently unmet in the market, at an affordable cost.
  • Pilot studies in patients suffering from contact dermatitis have been successfully completed and demonstrate marked efficacy compared to a placebo.
  • An 80 patient academic follow-up study has been issues with regulatory approval and is underway.

Inflammatory bowel disease (IBD)

  • Morria's MFAIDs have shown in vitro and in vivo data in both the DSS and TNBS-based IBD animal models.
  • Convincing results for injection and oral routes.
  • Phase I (oral drinking solution) in planning stages

Ophthalmology

  • Promising animal safety and efficacy data from independent third parties on conjunctivitis and dry eye models.
  • Eye drop formulation underway to be followed by further animal tox.

Cystic Fibrosis
A Cystic Fibrosis Foundation of America (CFF) grant sponsored scientific collaboration was launched by Morria Biopharmaceuticals and Columbia University to evaluate promising MFAID candidates for the treatment of cystic fibrosis. An accelerated pre-clinical development plan aimed at submitting an IND with the FDA is being prepared.

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