The News

Preglem SA inititates saphir study - a phase Ib clinical trial for its steroid sulfatase inhibitor

12/03/2008

Geneva, Switzerland, March 12th,  2008 –PregLem, the Swiss biopharmaceutical company specialized in reproductive medicine, announced that the German Health Authorities (BfArM) have granted Clinical Trial Authorisation for the company’s SAPHIR (Safety, tolerability, Pharmacokinetics and pharmacodynamic study in healthy pre-menopausal women with PGL2001) study. The 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.
PGL2001 is the company's lead NCE Steroid Sulfatase Inhibitor and represents a new concept for the treatment of endometriosis. Women in the SAPHIR study receive single or multiple (for 4 weeks) doses of PGL2001. Enrolment in the study will be completed by the end of 2008.
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.

Dr Ernest Loumaye, CEO of PregLem, said “This is the first of several important clinical milestones for the company. We are progressing according to targets in our four ambitious research and development programmes. The SAPHIR study is an important step for advancing PGL2001 towards a novel, once-a-week, oral medication for endometriosis.” 
Endometriosis affects tens of millions of women across the globe and is estimated to occur in one in five females, particularly those who have not yet had children. It is a major cause of pelvic pain and infertility in women. The disease is still poorly understood, most treatments have unpleasant side effects, and there is no cure. Endometriosis is caused by tissue similar to the lining of the uterus (the endometrial stroma and glands, which should only be located inside the uterus) migrating elsewhere in the body.

PregLem SA is a Swiss specialty biopharmaceutical company, founded in Geneva in 2006, by Ernest Loumaye and Eric Rolin. PregLem is focused on the development and commercialization of innovative therapeutic compounds for improving the treatment of significant benign gynecological conditions and infertility. PregLem has products at pre-clinical and clinical stages of development.

Solveig Hole  
PregLem CEO office
Tel.: +41.22.884.03.40
Email: Solveig.hole@preglem.com