Hybrigenics develops new oral formulations of inecalcitol

Hybrigenics seeks patent protection until 2030 for innovative oral formulations optimized for the delivery of high doses of inecalcitol

04-Nov-2010 - France

Hybrigenics announced the filing of a patent application covering new soft gelatin capsules, tablets or drinking solutions optimized for the delivery of high doses of inecalcitol. This pharmaceutical optimization followed the demonstration of safety and the presumption of efficacy of oral doses as high as 4 milligrams (mg) of inecalcitol per day in a Phase IIa clinical tolerance study in hormone-refractory prostate cancer patients. By contrast, currently marketed vitamin D analogues are prescribed in other indications at doses in the microgram range only. The superior tolerability of inecalcitol allows patient treatment at 1,000-fold higher dose levels. This higher dosing required innovative formulations.

All microdosed vitamin D analogues are currently marketed as oily solutions in soft gelatin capsules. The first formulations of inecalcitol were also soft gel capsules of different increasing concentrations and strengths, up to a maximum of 1 mg unit dose. The patients treated at the highest tolerated dose had to swallow four such relatively big capsules. The new capsules are more concentrated in inecalcitol and contain a fixed 2 mg amount. Treatment will therefore be more convenient with a maximum of two small capsules to swallow, favoring compliance.

Pharmaceutical stability and human bioavailability studies in healthy volunteers are ongoing. The objective is to start Phase IIb efficacy clinical trials in hormone-refractory prostate cancer and severe psoriasis with an already optimized formulation suitable for future commercialization.

https://www.bionity.com/en/news/125445/hybrigenics-develops-new-oral-formulations-of-inecalcitol.html