Uterine fibroids are benign tumors in the reproductive tract that contain large amounts of collagen which cause pelvic discomfort and pain, decreased fertility, pregnancy complications, increased rate of miscarriage, uterine bleeding, prolonged menstrual bleeding and frequent urination. Uterine fibroids are the leading cause of hysterectomies in the U.S., accounting for approximately 250,000 hysterectomies and 30,000 myomectomies each year. There are up to $9.4 billion in annual direct costs (surgery, hospital admissions, outpatient visits and medications).

BioSpecifics supported preclinical research with highly purified collagenase as an early step in the potential treatment for uterine fibroids. Studies at Duke Medicine indicated that the use of highly purified collagenase can reduce the stiffness of human uterine fibroid tissue in laboratory experiments. Increased tissue rigidity has been implicated as a cause of the morbidity associated with uterine fibroids. Laboratory research showed that treatment of fibroids with determined doses of purified collagenase causes a statistically significant decrease in the stiffness or the tissue and suggests that CCH could potentially be a minimally invasive treatment for this condition.

BioSpecifics conducted a Phase 1 open-label dose escalation study in fifteen subjects treated prior to hysterectomy at the Department of Gynecology & Obstetrics at Johns Hopkins University. The primary endpoint assessed the safety and tolerability of CCH following a one-time injection directly into uterine fibroids at three doses under transvaginal ultrasound guidance. The secondary endpoints assessed symptoms of pain and bleeding, quality of life throughout the study, size, collagen content and rate of apoptosis in CCH treated fibroids. Additional exploratory endpoints measured the tissue elasticity and assess relative stiffness using SWEI (Shear Wave Elasticity Imaging).

In March 2019, BioSpecifics reported positive results from the Phase 1 clinical trial of CCH for the treatment of uterine fibroids at the 66th Annual Scientific Meeting of the Society for Reproductive Investigation in Paris, France. Data from 12 patients demonstrated statistically significant reductions in collagen content (p<0.05) of CCH treated fibroids compared to control fibroids, a 39% (p<0.05) median reduction and an average of 21% reduction in density of collagen bundles in treated tissues vs control and no increases in apoptosis in treated tissues vs placebo. CCH demonstrated favorable safety and tolerability consistent with CCH clinical trials to date. Patients who reported pain at baseline demonstrated pain decreases within 24 to 48 hours, remaining low until the last visit at 60 to 90 days.