Hybrigenics acquires worldwide rights to inecalcitol, a vitamin D analogue

Hybrigenics SA announced that it has acquired a license for the worldwide exclusive rights to inecalcitol, a synthetic analogue of vitamin D, for all clinical indications.

Hybrigenics intends to focus on an oral formulation to develop inecalcitol in cancer indications, such as advanced androgen-independent prostate cancer, and expects this acquisition to rapidly move its R&D pipeline towards clinical development.

Vitamin D analogues are well known for their antiproliferative properties on psoriatic skin cells, but also on a wide variety of cancer cells. However, their therapeutic use has often been limited by hypercalcemia, a major physiological effect of natural vitamin D. The big advantage of inecalcitol is that it has a much lower hypercalcemic activity in vivo (100-200 times less than calcitriol, the active metabolite of vitamin D), and yet shows a more than 10-fold stronger inhibition of cancer cell growth in vitro.

Inecalcitol was discovered by a team of Belgian scientists from the Catholic University of Leuven, led by Professor R. Bouillon, and from the University of Gent led by Professors M. Vandewalle and P. De Clercq. Inecalcitol was then developed up to Phase II in psoriasis by topical administration by Theramex, an affiliate of Merck KGaA, Darmstadt, a company specialized in women’s health based in Monaco. Continuation of the psoriasis development or the use of inecalcitol in other indications, such as hyperparathyroidism, will be partnered, while cancer indications will be pursued by Hybrigenics.

“I am proud to see the development of inecalcitol widened to cancer by Hybrigenics, because inecalcitol really has the potential to be effective and well tolerated, thanks to its unique dissociation factor between hypercalcemia and cellular activity,” said Professor Roger Bouillon from the Catholic University of Leuven.

“Inecalcitol is a wonderful opportunity for Hybrigenics to have a product in clinical development in the near future,” said Remi Delansorne, Hybrigenics’ Chief Executive Officer. “More importantly, it may well bring an additional therapeutic benefit to refractory prostate cancer patients when combined with Taxotere(R), because calcitriol, the natural metabolite of vitamin D, has already shown some signs of efficacy in this clinical setting.”

Detailed financial terms of the licensing agreement between University of Gent, Catholic University of Leuven, Theramex and Hybrigenics were not disclosed.