Juniper Pharma (JNP) to Discontinue Development of COL-1077 After Phase 2b Trial Fails

August 17, 2016 5:27 PM EDT

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Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) today announced that a recently completed Phase 2b clinical trial evaluating its 10% lidocaine bioadhesive vaginal gel, COL-1077, for the reduction of pain intensity in women undergoing an endometrial biopsy with tenaculum placement did not achieve its primary and secondary endpoints. The safety and pharmacokinetic (PK) profiles of COL-1077 were consistent with what has been observed in prior clinical trials of the lidocaine bioadhesive vaginal gel.

"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," said Dr. Bridget A. Martell, Juniper's Chief Medical Officer. "On behalf of the Juniper team, I want to thank the patients and investigators who participated in this study."

"Based on the results of this trial, we are discontinuing development of COL-1077," said Alicia Secor, Chief Executive Officer. "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."

Juniper's IVR programs are led by JNP-0101, an investigational oxybutynin IVR for the treatment of overactive bladder (OAB) in women. Roughly nine million women receive pharmacotherapy for this chronic condition in the United States alone. IND-enabling animal PK studies are underway, and the Company expects pilot study results later this year.

"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," Ms. Secor added.

"We remain committed to delivering value-added treatments that meet the unique and underserved healthcare needs of women," Ms. Secor concluded.

COL-1077-07 Study Design

This Phase 2b randomized, double-blinded, placebo-controlled, multi-center clinical trial was designed to evaluate the safety and efficacy of COL-1077 10% lidocaine bioadhesive vaginal gel compared to a placebo bioadhesive gel for the reduction of pain intensity in women undergoing pipelle-directed endometrial biopsy with tenaculum placement. The primary efficacy endpoint was reduction in pain intensity at the time of endometrial biopsy on a validated 0-10 Numerical Pain Rating Score (NPRS), with secondary endpoints assessing the reduction in post-procedural pain and cramping over a 24-hour time period.

The trial enrolled 187 women (39 to 74 years old) at 25 sites across the United States. Patients were randomized on a 2:1 ratio to receive either COL-1077 10% lidocaine bioadhesive vaginal gel or placebo bioadhesive gel. Patients self-administered the gel approximately six hours prior to the scheduled outpatient appointment.

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