Approval and Funding Granted for a Phase II Clinical Trial of Inecalcitol in Psoriasis

Hybrigenics announced recently that AFSSAPS, the French drug agency, has granted authorisation for a Phase II  clinical trial with oral inecalcitol in patients with moderate-to-severe psoriasis under an Investigational Medicinal Product Dossier (IMPD) procedure. Hybrigenics also announces it has received a zero interest loan of EUR 650,000 from OSEO, the French financial institution supporting innovation, to cover 45% of the overall costs of the study.

The study will be conducted by professor Jean-Paul Ortonne in the Dermatology Department of the University Hospital of Nice, France. It will be a double-blinded and placebocontrolled trial comparing inecalcitol in 40 patients vs. placebo
in 20 patients. Inecalcitol will be given orally at four milligrams per day for 16 weeks.

"We are delighted to investigate the full anti-proliferative potential of inecalcitol in psoriasis, a second indication in
addition to prostate cancer. This study could extend the therapeutic potential of inecalcitol to non-cancerous
proliferative diseases," said Dr Jean-François Dufour- Lamartinie, head of clinical R&D.

"We are also grateful to OSEO for its support to finance nearly half the cost of this Phase II trial. Oral treatment of  moderate-tosevere psoriasis by inecalcitol would be a major breakthrough as compared with older oral drugs such  as cyclosporin, methotrexate or retinoids which are immunosuppressant or teratogenic. The convenience of oral  dministration of inecalcitol would also represent an alternative of choice to more recent but injectable biological  treatments."