LONDON - Shares in Cortecs plc fell by more than a quarter last week, to 14.5 pence (US$0.23), when the company announced it was dropping its lead product, Macritonin, oral calcitonin for the treatment of osteoporosis, after it failed in Phase III trials.
This is a blow for the company, which is in the process of a massive retrenchment, following the departure last year of its founding CEO and other directors, and the admission that two of its three lead programs were not as advanced as previously indicated.
Following a review, the new CEO, Phil Gould, said in February 1999 that the Macritonin Phase III European trial would be evaluated after one year, rather than the two originally scheduled, saving #60,000 per week. At the same time, the company said it was seeking a partner for Macritonin and was planning a three-year, Phase III U.S. trial.
The aim of the European trial was to show equivalence with orally delivered calcitonin. However, last week Cortecs said analysis of bone-mineral density data from 388 patients who received study treatment for one year and 193 who completed two years of study had failed to show this. Comparison of the effects of Macritonin on bone-mineral density against placebo in both groups showed no significant effect at the three doses evaluated. This is in contrast to an interim analysis based on 189 patients, announced in October 1998, which suggested a dose-related effect on bone-mineral density.
The trend of effects seen in patients who received Macritonin was lower than that seen in the intranasal administration of calcitonin. Furthermore, a concurrent analysis of biochemical markers of bone turnover failed to show any significant effect of Macritonin on bone turnover.
Cortecs has already made regulatory submissions in the seven European countries where nasal calcitonin is registered, and signed up distribution partners in several European countries on the basis of bone-marker data. The company said it is now assessing its position in relation to the submissions and the partners.
Gould said Cortecs has now completed the shift from being a fully integrated company focussed on commercialization, to one specializing in early-stage research and development. "We are now satisfied with the rigor of our existing clinical trial programs and development priorities," he said.
He noted the decision to discontinue the Macritonin program will enable the company to reduce its expenditures further. "We are rebuilding a vigorous company based on programs with robust science and commercial potential," he said.
Cortecs now has two compounds in clinical trials: Pseudostat, an oral mucosal vaccine for respiratory diseases, which is in Phase I/II trials; and Macrulin, an oral formulation of insulin for the treatment of Type II diabetics. Clinical trials in diabetic patients assessing multiple doses with food are now complete. The results will be released in June and, the company said, if the results are positive, it will look for a partner. It stressed that Macrulin is not based on the Bridge-lock delivery system used in Macritonin.