(MFAIDs) combine two promising approaches to preventing and reversing inflammation:
- Novel control of the key inflammatory enzyme family Phospholipase A2 and;
- Enrichment of naturally occurring anti-inflammatory components of the cell surface.

PLA2 has long been recognized as a high-value target for anti-inflammatory therapy but despite numerous attempts, no drug has yet to reach the market. Morria's approach is radically different to past attempts and current pharmaceutical indications are promising.

Morria has demonstrated the potential efficacy of MFAIDs in diverse in vitro and in vivo systems applicable to inflammation of the skin, airways, intestines, CNS and Severe Inflammatory Response Syndrome ( SIRS).

A recently published pilot study in contact dermatitis patients yielded promising data, providing a first-in-man efficacy demonstration.

Safety and efficacy clinical studies (Phase I/IIa) in contact dermatitis (topical) are scheduled for the winter of 2008. An allergic rhinitis (nasal) Phase II study (n=105) is currently underway in South Africa.

Morria Product Development 

 Collaborative R&D programs  

Inflammatory diseases of the skin (Contact Dermatitis)
Skin allergic/inflammatory diseases are a $5bn market dominated by topical corticosteroids. Dermatology is a market characterized by low development costs coupled with low risk of failure. Several topical drugs are selling in excess of $250m a year. Novartis’s Elidel® was predicted to surpass the $1bn mark before concerns regarding toxicity affected its sales.

• 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 completed successfully and demonstrating marked efficacy compared to placebo.  

Respiratory inflammatory diseases: (Allergic Rhinitis, Asthma & COPD)
Respiratory inflammatory/allergic diseases include allergic rhinitis (AR), asthma and COPD. AR has the lowest development costs and a market valued at $9bn. Anti-inflammatory steroids given intranasally to AR patients is also given by inhaler to asthma patients ($12bn market). There are few effective treatments for the inflammatory component of COPD, a disease affecting 600m patients worldwide. Singulair®, the only non-steroidal drug in these markets has annual sales in excess of $2.5bn despite limited efficacy.  

• Morria’s MFAIDs uniquely target key events in respiratory inflammation. MFAIDs have shown promising efficacy in animal studies exhibiting a clear Preventer-like drug functionality as well as an unexpected Reliever-like functionality.
• MFAIDs could offer patients the convenience and potency of the best current treatments without the usual severe side effects and at an affordable price.
• MFAIDs are administered by inhaler (asthma) or nasal spray (allergic rhinitis).

Inflammatory Bowel Disease
Inflammatory bowel disease (Crohn’s disease and ulcerative colitis) is a $3bn market characterized by high expenditure per patient ratios and commonly treated by steroids. Apart from being a lucrative market in its own right, IBD is also a recognized stepping stone to other severe chronic inflammatory diseases such as arthritis.  

• 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.

Cystic Fibrosis

CF is an “orphan” disease and as such can receive market exclusivity for a period of 10 years from the FDA. CF drug sales in the US in 2003 were $300m with only two drugs available, neither one an anti-inflammatory. With 30,000 patients in the US , annual sales for an efficient inhaled drug could potentially reach in excess of $250m.

A scientific collaboration was launched by Morria Biopharmaceuticals with Professor Alice Prince of Columbia University to evaluate promising MFAID candidates for treatment of cystic fibrosis. The study was sponsored by a grant from the Cystic Fibrosis Foundation of America (CFF). Data clearly showed efficacy in CF cells and promising indications in animal models. An accelerated pre-clinical development plan aimed at submitting an IND with the FDA is being prepared.