Juniper announces enrollment of first patient in COL-1077 Phase II trial to reduce pain during endometrial biopsy

Juniper Pharmaceuticals, Inc.Jun 15 2015

Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper"), a specialty pharmaceutical company focused on the development of therapeutics for women's health, announced today the first patient has been enrolled in a Phase II clinical trial of COL-1077, a 10% lidocaine bioadhesive gel that is intended as an acute-use anesthetic during minimally invasive gynecologic procedures.

This clinical trial will evaluate the safety and efficacy of COL-1077 to reduce pain experienced during and after an endometrial biopsy. This common gynecological procedure helps in the diagnosis of conditions such as abnormal menstrual bleeding, pelvic tenderness, endometrial hyperplasia, and uterine cancer.

"An estimated five to six million minimally invasive gynecological procedures are performed annually in the U.S. alone, and the pain and discomfort patients experience when undergoing these procedures is real and significant. COL-1077 is potentially an elegant solution that we expect will effectively reduce women's pain during gynecologic procedures and improve their clinical experience," said Bridget Martell, M.A., M.D., Juniper's Chief Medical Officer.

The multicenter clinical trial will study 150 patients undergoing pipelle-directed endometrial biopsy with tenaculum placement at 15 research sites across the United States. Through, random, double-blind assignment, the study will compare a single dose of COL-1077 (10% lidocaine bioadhesive gel) versus a placebo. COL-1077 is a sustained-released proprietary gel that is self-administered vaginally.

The study will assess the reduction in pain intensity during the endometrial biopsy and time points up to 24 hours after the procedure as compared to placebo. Safety assessments, use of "rescue" pain medications, and patient-related outcome measures, such as time to return to work following the biopsy will be also examined. Study results are expected in mid-2016.

Juniper's research and development program is guided by its Scientific Advisory Board comprised of internationally renowned physicians and scientists including Dr. Robert Langer (Massachusetts Institute of Technology), Dr. William Crowley (Massachusetts General Hospital/Harvard Medical School), Dr. Ginger Constantine and Dr. Daniel Shames, under the chairmanship of Dr. Martyn Davies (University of Nottingham School of Pharmacy).

COL-1077 is the first in a series of value-creating drug compounds Juniper expects to advance into clinical development; announcement of the next product candidate is expected later this year. The specialty pharmaceutical company plans to use cash flow generated by its CRINONE^® franchise and service business to substantially fund its drug development.