InKine Pharmaceutical Co. Inc. decided to continue its pivotal Phase III program of CBP-1011 following encouraging initial data and discussions with the FDA.
The drug, an orally administered steroid, is being developed to treat the platelet disorder idiopathic thrombocytopenic purpura. The initial data was gathered from 40 patients in the open-label study designed to enroll 100.
The Blue Bell, Pa., company now will move forward in changing the formulation from capsules to tablets, since the product does not lend itself to large-scale capsulation, said Leonard Jacob, InKine's chairman and CEO.
"We were not going to spend half a million dollars on a tablet formulation if we weren't sure the product had a chance of becoming a drug," Jacob said. "And more importantly, if the FDA didn't feel there was a need for this product."
Jacob said early results appeared to show CBP-1011 was working pretty well and had an excellent side-effect profile, which would be a significant advantage over the standard treatment, prednisone. He said the FDA didn't review efficacy data but did see enough to suggest continuation was worthwhile. The agency also supported orphan drug status for CBP-1011, Jacob said.
After conversion to tablet form a pharmacokinetic study will be performed in healthy volunteers. Jacob said it will be run simultaneously to the efficacy study, and be expected to take about three months. He estimated the study might end about six months after that, putting completion next year and about a year behind the company's lead product, Diacol. (See BioWorld Today, April 30, 1999, p. 1.)
InKine plans to file a new drug application for Diacol, a purgative agent, later this year. The idea with both Diacol and CBP-1011 is to improve on existing treatments through better tolerability and side-effect profiles.
InKine's stock (NASDAQ:INKP) closed Monday at $1.593. - Jim Shrine