Fast Track designation was recently granted for iCo-008 use in bullous pemphigoid (BP) by the US Food and Drug Administration (FDA).
The FDA has also recently granted orphan drug designation to iCo-008 for the treatment of bullous pemphigoid.
Bertilimumab is a fully human monoclonal antibody with specificity for human eotaxin-1 and inhibits its function.
Eotaxin-1 is a potent activator and chemoattractant of eosinophils (disease fighting human white blood cells). Increased numbers of eosinophils are a feature of a number of diseases including those of allergic origin (for example asthma, rhinitis, inflammatory bowel diseases and more severe conjunctivitis), and in many cases are believed to be the major cells effecting tissue damage.
Eosinophil degranulation products have been shown to have significant toxic effects on tissues, and cytokines known to be released by eosinophils enhance the inflammatory cascade.
Eotaxin-1 has a significant role in the process by which eosinophils are recruited into tissues. It is also involved in eosinophil activation. By blocking eotaxin-1 one may be able to prevent or reduce tissue eosinophil accumulation and as a result prevent subsequent tissue injury.
Favourable results from pre-clinical assessments resulted in three clinical studies of bertilimumab conducted in EU (a total of 126 patients – healthy individuals, patients with a history of seasonal allergic rhinitis and individuals with a history of seasonal allergic conjunctivitis) provided evidence of good safety and tolerability of bertilimumab when administered by the intravenous (IV) or intranasal route as well as topical application to the eye.
More recently, bertilimumab has been investigated in two Phase 2 trials. The first trial targeted patients with a skin condition called bullous pemphigoid and revealed good safety and efficacy results. A second trial has been carried out in patients with an inflammatory bowel disease called ulcerative colitis.
Results from this trial are still pending. A Phase 2 clinical trial for patients with vernal keratoconjunctivitis and/or atopic keratoconjunctivitis (involving cornea and conjunctiva) is in preparation. A number of other indications have also been considered.
Therapy with bertilimumab could be useful in treatments of a number of diseases where steroids and immune-suppressants or other drugs may need to be prescribed chronically (a number of these diseases appears to be seasonal) often resulting in adverse reactions that may become serious over time.