Originally filed in 2009, this patent will cover inecalcitol doses higher than one milligram (mg) per day until 2029. Currently-marketed vitamin D analogues for their usual indications such as rickets, osteoporosis or chronic kidney disease do not exceed 10 microgram per day, i.e. 100 times lower doses. The maximal tolerated dose of inecalcitol has been established at four mg per day in hormone-refractory prostate cancer patients. The ability to treat patients with a vitamin D analogue in the milligram dose range is totally new. This makes inecalcitol uniquely suited to reach efficacious levels without side effects in new challenging indications such as cancer or psoriasis by oral administration.
The same patent application is still under examination by the United States Patent and Trademark Office and by the World Intellectual Property Organization under the Patent Cooperation Treaty (PCT) procedure, to get full worldwide protection. “This patent stems from proprietary findings generated by Hybrigenics and will be further strengthening the existing intellectual property position of inecalcitol for 20 years,” said Rémi Delansorne, Hybrigenics’ CEO.