LONDON ¿ Cortecs plc, of Deeside, said it has ¿unequivocal evidence¿ that its oral formulation of insulin can deliver biologically active insulin through intestinal absorption, following a preliminary analysis of a Phase IIa study of the product, Macrulin, in Type I diabetics.
Phil Gould, CEO of Cortecs, told BioWorld International, ¿In Type I patients, insulin was absorbed by four out of six, and there was a reduction in glucose levels in four out of six.¿ Why Macrulin was not absorbed in two of the six subjects is being investigated.
A previous trial with Type II diabetics showed intestinal uptake had occurred, but Gould said the trial was ¿awkward¿ because of the difficulty of determining what level of insulin was absorbed and how much had been produced naturally.
¿This study [in Type I] is unequivocal, because Type I diabetics don¿t produce any insulin,¿ he said.
The new data come from a series of studies currently under way to confirm a commercial dosage. Single-dose studies were conducted in Type I diabetics, and an initial multiple-dose, one-day study was conducted in Type II diabetics. The full analysis will be available at the end of May.
Macrulin was reformulated in 1998 to make it easier to manufacture and provide a longer shelf life. Cortecs is aiming for equivalence (in terms of the product¿s physical characteristics) with existing insulin formulations.
Gould said he expects to find a partner for the drug in the second half of 1999. Cortecs believes Macrulin is the only oral insulin in development, and it is aimed at Type II diabetics. The previous clinical trial in Type II diabetics indicated successful hepatic delivery, which is believed to reduce side effects in these patients.
Cortecs published this data as it released interim financial results for the six months ended Dec. 31, 1998, showing earnings down 18 percent, to #3.2 million (US$5.2 million), on the same period in 1997. The company recorded a loss of #11.5 million, up from #9.1 million. Research and development costs rose by 8 percent, to #8.1 million. Most of the increase was due to the formation of a separate subsidiary, OraTol Ltd. As of Dec. 31, the company had #20 million in cash, of which #4.6 million was available only for OraTol activities.
Cortecs also disclosed further restructuring plans following 90 layoffs, the closure of three offices and the ending of scientific collaborations, made public in January. In order to focus the company group further, Cortecs said it will dispose of its food diagnostics, laboratory services and pharmaceutical sales and marketing businesses. ¿They are cash-neutral, and have sufficient value that it is worth doing,¿ Gould said. The sale is expected to raise less than #10 million.
The overall aim of the restructuring is to reduce the annual cash burn to less than #10 million.