BioWorld International Correspondent
LONDON Alizyme plc said it has received approval for its first Phase III clinical trial of Colal-Pred for maintaining remission in patients with ulcerative colitis (UC), and announced Phase IIb data in patients with the active form of the disease, allowing Phase III trials in the treatment of active UC to start before the end of 2002. The share price rose by 32 percent to 70 pence when the news was released last week.
Alizyme CEO Richard Palmer said the entry of its first product into Phase III development, coupled with the Phase II results, “is an important landmark for the company and reinforces the excellent progress being made across our product portfolio.”
Colal-Pred is a proprietary formulation of prednisolone, a steroid commonly used to treat UC, which is coated to ensure that the drug is not released until it reaches the colon. The Phase II trial demonstrated efficacy without the usual dose-limiting side effects of steroid treatment.
As prednisolone already is approved in several European countries, the Phase III trials are not expected to be as extensive as normally required for a new drug. Nick Staples, an analyst at West LB Panmure, said Alizyme has “both the cash and capability to conduct one, or both, trials before seeking a licensing partner.”
The randomized, double-blind Phase III trial in patients in remission will compare Colal-Pred with mesalazine, the current standard treatment. Patients will be treated for 12 months, during which time about 35 percent would be expected to relapse on mesalazine. Alizyme, based in Cambridge, said products for the maintenance of remission account for at least half of the worldwide market for UC drugs (US$500 million per annum), and that a safer product that reduces the relapse rate would be attractive for this market.
In the Phase II trial in 37 patients with mild to moderate active UC, Colal-Pred showed a similar effect to other formulations of prednisolone, but with no steroid-related side effects. One of the investigators, Christopher Hawkey, consultant gastroenterologist at Queens University Medical Center in Nottingham, said, “Obtaining a clinical response in ulcerative colitis patients without the usual debilitating steroid side effects would be an important advance and these results with Colal-Pred are very promising.”