Neurocrine announces positive phase 2 results with its small molecule antagonist in endometriosis

By Lisa Kerner

Erie, Pa., April 27 - Neurocrine Biosciences, Inc. announced positive results of its proof-of- concept, safety, efficacy and dose-finding phase 2 clinical trial of its orally active small molecule Gonadotropin-Releasing Hormone receptor antagonist (NBI-56418).

The three-month data comes from a multi-center, randomized, double-blind, placebo-controlled trial of 76 patients with endometriosis, according to a company news release.

Patients were randomized to one of three treatment groups: placebo, 75 mg of NBI-56418, or 150 mg of NBI-56418 each administered once daily. Dosing started on day 2 to day 7 of the menstrual cycle and continued over 12 weeks.

The Composite Pelvic Sign and Symptoms Score was used to assess symptoms and signs of disease at four-week intervals, the company said.

Assessment of pain intensity was measured daily by a Visual Analog Scale and collected by electronic diary.

The primary endpoint of the study was reduction in the symptoms score.

Mean values of the score at baseline were 9.1, 8.5 and 8.0 for the placebo, 75 mg and 150 mg groups respectively. At week 12 following treatment, reductions of 3.7 (placebo), 3.9 (75 mg) and 5.0 (150 mg) points of the score score were observed.

Based on the study data, Neurocrine plans to select the dosing regimen for an expanded six-month phase 2b study of several hundred patients with endometriosis.

Neurocrine is a San Diego-based product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.