Prometheus fires pellets for colon treatment

By encasing a generic steroid (prednisolone sodium metasulfobenzoate) in Alizyme's delivery technology the drug is released only when it reaches the colon as the pellet is broken down solely by bacteria found there.

This protects patient from the side effects of steroids, which include weight gain, mood swings, 'moon face', osteoporosis and immunosuppression.

Roger Hickling, R&D director at Alizyme, explained the delivery system to in-PharmaTechnologist.com: " When the patient swallows a capsule, the capsule is dissolved in the stomach in the usual way releasing the coated pellets. "

The coated pellets pass through the stomach and small intestine intact.

The coat on the pellets is only broken down once the pellets reach the colon, thus releasing the active steroid ."

Alizyme's pellets are composed of ethylcellulose and a form of starch called 'glassy amylose'.

This 'glassy amylose' cannot be broken down by human enzymes throughout the gastrointestinal tract.

Upon reaching the colon its bacterial enzymes begin degrading the 'glassy amylose' in the capsule, releasing the steroid directly into the affected area.

This has an anti-inflammatory effect on the affected region, alleviating the symptoms of abdominal pain, bleeding, cramping, fatigue and diarrhoea associated with the ailment.

The two million who suffer from ulcerative colitis in what Alizyme describes as the "major territories" currently have to use untargeted anti-inflammatory steroids or 5-ASA as treatments.

However, taking untargeted anti-inflammatory steroids can induce the raft of side effects mentioned previously.

5-ASA also has problems with side effects.

In addition Hickling informed in-PharmaTechnologist.com that 5-ASA is suitable only for treating " mild to moderate ulcerative colitis ".

Steroids could be used for all cases of ulcerative colitis if the side effects are negated, according to Hickling.

He said: " T he reason corticosteroids are not used in more mild disease is because of the poor tolerability of systemically absorbed steroids ."

The ability to minimise side effects and target the colon opens up the possibility of Alizyme's technology being used in the treatment of other ailments affecting the region.

Hickling said: " We have done feasibility work with other compounds up to Phase I but none beyond that at present ."

Potential applications could include the treatment of colonic cancer or Crohn's colitis.

For now though, the focus is on Colal-Pred, with a new drug application anticipated in 201l.

Developments are at a later stage in Europe, where the drug may be in the market in the second half of 2009.