Research & Development

With the vision of becoming a leading biopharmaceutical company in the field of women’s reproductive medicine, PregLem is focusing its research and development activities on developing non-invasive medical treatments for common, underserved gynaecological conditions that have a severe impact on the sufferers, in which current treatments remain unsatisfactory, and in many cases, have severe side effects.

Information about PregLem-Sponsored Clinical Trials: PregLem is committed to providing information about clinical trials sponsored by the Company. We register our company-sponsored ongoing Phase III clinical trials on the National Institutes of Health's (NIH) web site (www.clinicaltrials.gov).

Uterine Fibroids

Uterine fibroids (myoma) are the most common benign, solid tumours of the female genital tract in women of reproductive age, affecting over 40 million women of reproductive age in Europe and USA. Cardinal symptoms:

Heavy menstrual bleeding and anemia
Abdominal pain and pressure
Increased urinary frequency
Infertility

It is a leading cause of hysterectomy.

Esmya^®
(Ulipristal Acetate / PGL4001)
European Marketing Authorization received in February 2012

Endometriosis

Endometriosis is a benign gynaecological disease characterised by the presence of functional endometrial tissue fragments growing outside the uterus cavity, most frequently on the peritoneum, the ovaries, and the bowel. Endometriosis affects over 20 million women of reproductive age (EU & USA) with 5 million suffering from chronic pelvic pain.

Main symptoms:

Chronic pelvic pain
Painful menstruations
Dyspareunia (painful sexual intercourse)
Infertility

PGL2001
(Steroid Sulfatase Inhibitor, STS-I)
Phase IIa

PGL5001
(c-Jun-N-Terminal Kinase Inhibitor (JNK-I), Bentamapimod)
Phase IIa / Proof of Concept (POC)

Infertility

Infertility is a condition described as the failure to conceive after regular unprotected intercourse during at least one year for couples below 35 years and during 6 months for couples above 35 years. It affects 10 million couples in the EU, 6 million in the USA and 80 million worldwide.

PGL1001
(Somatostatin Antagonist, SST-ATG)
Ovarian Reserve Modulation: Pre-Clinical Development

Post-Surgical Adhesions

Adhesion formation is a common outcome of surgery, occurring in 90-95% of patients. Approximately 4 million pelvic and abdominal surgery procedures are performed each year in the EU, and a similar number in the US. There can be an adhesion between organs in the pelvis, bowel to bowel, bowel to uterus, bowel to the ovary, or to the abdominal wall. At their most extreme, they can result in infertility, pain and bowel obstructions. Endometriosis and Endometriosis-related pelvic surgery are leading causes of abdominal adhesions.