HRA and PregLem drug improves QoL in UF

HRA Pharma, a privately-held French pharmaceutical company that designs products, devices and supporting services in reproductive health and  endocrinology, and PregLem, a Swiss biopharmaceutical firm specializing  in women's reproductive medicine, have successfully completed a Phase  IIb study of the compound ulipristal acetate for the treatment of  uterine fibroids. The protocol was a follow-on to the recently-published  Phase IIa trial, which demonstrated in a placebo-controlled design that  the drug is effective in rapidly controlling bleeding and reducing  fibroid volume in women with symptomatic uterine fibroids.

Ulipristal acetate (also known as CDB-2914 and PGL4001) is a  first-in-class, orally-active selective progesterone receptor modulator  that reversibly blocks such receptors in target tissues. The Phase IIb  trial was a double-blind, placebo-controlled, dose finding study of 40  patients with symptomatic uterine fibroids. Ulipristal acetate or a  matching placebo was administered for 12 weeks. The primary outcome  measures were shrinkage of fibroids and patient quality of life.

PregLem chief executive Ernest Loumaye said: "PGL4001 is the first  potential medical treatment for uterine fibroids that rapidly controls  the bleeding and effectively reduces the size of fibroids. We are  pleased to observe the excellent efficacy of PGL4001 in quickly and  sustainably controlling the symptoms related to fibroids."