Juniper’s COL-1077 fails to achieve primary, secondary goals

Juniper Pharmaceuticals Inc. announced last week its Phase 2b clinical trial for COL-1077, which was recently completed, did not meet either its primary or secondary goals.

COL-1077, a 10% lidocaine bioadhesive vaginal gel, was designed to reduce the intensity of pain in women undergoing an endometrial biopsy with tenaculum placement.

"We are disappointed that COL-1077 did not achieve the desired effect in this clinical trial.  We believe the study was well designed and conducted, and has adequately tested our hypothesis," Juniper CMO Dr. Bridget A. Martell said.  "On behalf of the Juniper team, I want to thank the patients and investigators who participated in this study."

COL-1077’s safety and pharmacokinetic (PK) profiles were consistent with the observations of the lidocaine bioadhesive vaginal gel from before the clinical trials.

"Based on the results of this trial, we are discontinuing development of COL-1077," Juniper CEO Alicia Secor said. "We will focus Juniper's resources on our differentiated intravaginal ring (IVR) technology to advance our pipeline of product candidates to address unmet needs in women's health. We expect to fund our operations and planned R&D activities with cash flows generated by our core business. We expect ongoing strong performance from the Crinone franchise and Juniper Pharma Services.”