Cambridge-based Alizyme says it has completed patient recruitment in a late-stage trial of its ulcerative colitis agent Colal-Pred, and that headline results are now expected in June.

If the trial is successful, the company plans to submit a Marketing Authorisation Application to the European authorities in the second half of the year, it said, which could see the product on the market in 2009.

Colal-Pred, which combines Alizyme's proprietary colonic drug delivery system Colal with the steroid prednisolone sodium metasulfobenzoate, has a starch coating that is only broken down in the gut by bacteria in the colon, allowing for topical rather than systemic delivery of the agent.

Towards the end of last year, Alizyme signed up two co-development and marketing partners for Colal-Pred - TSD in Japan and Prometheus in the USA – to facilitate the drug’s entry onto these markets, and the company said it expects “concluding additional territorial transactions during 2008”.

Meanwhile, the firm is also making progress in other areas of its pipeline:

- a Phase III development programme for obesity drug cetilistat has been agreed with US regulators, and is ready to kick off as soon as a development and commercialisation partner found;
- headline trial results from Study 038, the first pivotal efficacy Phase III study of renzapride in constipation-predominant irritable bowel syndrome, are on track to be unveiled in April; and
- a second Phase II study of ATL-104 is scheduled for the second half of 2008, assessing the agent in patients with solid cancer tumours suffering from mucositis, which could expand the drug’s commercial potential.

The company is obviously pleased with its achievements, and chief executive Tim McCarthy confirmed that the group is in a number of “ongoing discussions with potential partners for the commercialisation of our products, and this activity, together with results from our two Phase III clinical studies and further clinical development progress, will provide for significant news flow through 2008."