LONDON ¿ Drug-delivery company Cortecs plc, of Deeside, said it will conclude its European Phase III trials of Macritonin, oral calcitonin for the treatment of postmenopausal osteoporosis, after one year, rather than after the two originally scheduled, at a savings of #60,000 (US$96,000) per week.
The company said it is now in a position to collect and analyze full one-year bone-mineral density data and bone-marker data for 400 patients to supplement the dossier already submitted. It is seeking approval in a number of European countries on the basis of equivalence with nasal calcitonin and believes that the one-year trial will provide sufficient data for registration in those countries where the nasal form of calcitonin is registered.
Following consultation with commercial partners and regulatory advisers, Cortecs is now planning a three-year trial in the U.S., which will commence once the company has found a partner. It is in the process of recruiting a U.S. adviser to assist with the development of clinical protocols, and will submit the U.S. data in those countries in Europe that will not approve the drug on the basis of equivalence with nasal calcitonin.
A spokesman told BioWorld International that the European trial was being stopped not to save costs, but because ¿the clinical objectives will be better served by setting up a U.S. trial based on the findings to date.¿ There is no progress to report on the search for a U.S. partner.
This was seen as good news by investors, and the share price rose 2.25 pence to 22.75 pence.
In January, Cortecs said it was laying off 75 of its 270 staff members, scaling back research collaborations and closing its London headquarters and New York office to cut the burn rate from #17 million per annum to less than #10 million. This followed the admission in December that two of the company¿s three leading compounds ¿ Macritonin, and Pseudostat for the treatment of chronic bronchitis ¿ were not as advanced as previously described. n