19-May-2010 - PregLem SA

PregLem announces positive phase III results for Esmya as a treatment for uterine fibroids

PEARL II study meets both primary efficacy and safety endpoints

PregLem announced positive Phase III results of EsmyaTM(ulipristal acetate) for the treatment of symptomatic uterine fibroids (myoma). The PEARL II study assessed the efficacy and safety of EsmyaTMcompared to the only currently approved treatment, a GnRH (gonadotropin-releasing hormone) agonist.

The PEARL II study was designed to assess the efficacy and safety of EsmyaTM, an oral therapy, compared to the injectable GnRH agonist Leuprorelin, for the treatment of symptomatic uterine fibroids in patients eligible for surgery. This randomised, parallel group, double-blind, double-dummy, multi-center study involved a total of 307 patients and compared EsmyaTM 5mg or 10mg orally, once-a-day with Leuprorelin 3.75 mg monthly injections.

The study met its primary efficacy and safety endpoints. EsmyaTM met the pre-defined, non inferiority efficacy endpoint versus Leuprorelin to reduce excessive uterine bleeding caused by uterine myomas. The primary endpoint was change from baseline in the bleeding intensity score. This was measured as a percentage of patients with a reduction of PBAC (Pictorial Blood Assessment Chart) score to lower than 75 after 3 months of treatment. EsmyaTM demonstrated superior safety and tolerance with statistical significance versus Leuprorelin regarding castration-related symptoms and their consequences. The principal parameters were serum oestradiol levels and hot flushes.

Professor Jacques Donnez, from Louvain University (Belgium), the Principal investigator said: “These data are very promising. There has been a lack of innovative and effective products to treat uterine fibroids. This is a significant and distressing problem for many women and has a serious impact on their lives. These results clearly illu

Facts, background information, dossiers
More about PregLem
  • News

    PregLem announces positivie phase III results from Esmya

    PregLem announced positive Phase III data from its second pivotal study (PEARL I) for its lead product Esmya (ulipristal acetate), as an effective treatment for uterine fibroids (myoma). The final set of positive Phase III results, combined with the positive PEARL II results announced in M ... more

    PregLem starts Phase III trials of PGL4001 in Uterine Myoma

    PregLem SA announced the start of an international Phase III clinical trial program for PGL4001 (ulipristal) in symptomatic uterine myoma, a common benign solid tumor of the genital tract in women of reproductive age. PGL4001, an orally active, selective progesterone receptor modulator, was ... more

  • Companies

    PregLem SA

    PregLem is a European speciality biopharmaceutical company, dedicated to the development and commercialization of a new class of drugs for women’s reproductive health conditions. PregLem has an experienced senior management team, with a proven track record in developing, registering and co ... more