NeuroBo Pharmaceuticals, Inc., a clinical-stage biotechnology company focused on novel, disease-modifying therapies for neurodegenerative diseases today announced its plans to initiate a Phase 3 trial to evaluate the efficacy of its lead drug, NB-01, in diabetic neuropathic pain early this year.
“The planned initiation of our Phase 3 study for NB-01 marks a crucial milestone not just for NeuroBo, but for the study of neuropathic pain broadly,” said John L. Brooks III, president, and chief executive officer, NeuroBo Pharmaceuticals. “Neuropathic pain affects more than 80 million patients today and our drug has tremendous potential to impact patient care with a safe and efficacious oral therapy.”
NB-01 has previously shown successful Phase 2 results in treating diabetic neuropathic pain demonstrating a high efficacy in pain reduction with minimal to no side effects versus placebo – a highly desirable product profile compared to existing approved drugs in the market.
The phase 3 study is a double-blind, placebo-controlled, 12-week study, which will randomize approximately 717 adults with diabetic neuropathic pain at up to 80 sites in the U.S.
NeuroBo also plans to launch a second pivotal phase 3 study globally for NB-01 with a similar design in mid-2020.
The primary endpoint for both studies is change from baseline to week 12 of the weekly mean of daily pain scores (an 11-point Pain Intensity Numerical Rating Score, PI-NRS), using an electronic patient diary.
The key secondary endpoint is the number of responders on the Patient Global Impression of Change Scale (PGIS), defined as “much improved” or “very much improved.”
NeuroBo plans to conduct an interim analysis of results during the first half of 2020 and expects to complete the study mid-2021.
- NeuroBo Pharmaceuticals to Initiate Phase III Clinical Trial of NB-01 in Adult Patients with Diabetic Neuropathic Pain. (2018, Jan. 9) BusinessWire. Retrieved: https://www.businesswire.com/news/home/20190108005175/en