This study is a Phase Ib clinical trial in healthy pre-menopausal women. PregLem’s investigational product (PGL2001) has already been administered to the first women. Women in the Saphir study will receive single or multiple (for four weeks) doses of PGL2001. Enrollment in the study will be completed by the end of 2008.
PGL2001 is the company’s lead NCE steroid sulfatase inhibitor and represents a new concept for the treatment of endometriosis. To date, over 170 women of post-menopausal age have been exposed to PGL2001 in Phase I studies at different doses and with different regimen of administration. The drug is active and has shown to be safe and well tolerated at all tested doses.
Ernest Loumaye, CEO of PregLem, said: “The Saphir study is an important step for advancing PGL2001 towards a novel, once-a-week, oral medication for endometriosis.”