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Crofelemer

A proprietary gastro-intestinal compound in clinical development for four distinct product indications

market

Pediatric diarrhea, market (product: CRO-PED)

In 2003, it is estimated that over 5 million children under 5 years of age living in developing countries died of dehydration caused by diarrhea. Because diarrhea can be caused by a variety of infectious agents, these are difficult to treat in the clinical setting. Recent introduction of a rotavirus vaccine may help, but a vaccination approach focusing on just one pathogen does not adequately protect the child from infectious diarrhea.

Three pathogens, (rotavirus, ETEC and V. cholerae) are primarily associated with secretory diarrhea. In developing countries, it is estimated that 4 billion episodes of acute diarrhea occur among children under 5 years of age. Morbidity due to persistent diarrhea is increasing; studies have shown that there is a lasting, long-term impact of early childhood diarrhea (i.e. diarrhea during the first 2 years of life) on:

  • growth
  • fitness
  • cognitive function
  • school performance in children 6-12 years of age

The company believes that optimal anti-diarrheal therapies for the pediatric population are still lacking. Current management of pediatric diarrhea relies on electrolyte and fluid replacement which do not treat the underlying cause of the diarrhea. OTC anti-motility agents, such as Imodium, work by the mechanism of slowing down motility in the intestines. If used too much or for too long, these agents can cause constipation. They cannot be used in children under 6 years of age due to dangers of stopping normal gut function in individuals with immature immune systems. The anti-motility agents are opiate derivatives. Infants and children, who have a varying degree of blood-brain barrier maturation, are at risk of accidental overdosage, which can lead to unacceptable consequences and sometimes fatal intoxication.

The company believes that the development of CRO-PED will lead to a better treatment for secretory diarrhea in the pediatric population, as crofelemer stops the devastating water loss and dehydration without affecting normal intestinal motility causing opiate-like toxicity.