NeuroBo Pharmaceuticals announced its plans to initiate a Phase III trial to evaluate the efficacy of its lead drug, NB-01, in diabetic neuropathic pain in early Q2, 2019. The Company’s drug pipeline also includes an IND-ready therapeutic candidate for Alzheimer’s disease. These two candidates are based on extensive clinical and/or preclinical R&D originally conducted by Dong-A ST, a major Korean pharmaceutical company.

“The planned initiation of our Phase III 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.”

The Phase III 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 US. NeuroBo also plans to launch a second pivotal Phase III 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.

In addition to pain alleviation, preclinical work on NB-01 has demonstrated effects on increasing the release of nerve growth factor (NGF), stimulating nerve growth, and inhibiting advanced glycation end-products (AGEs) and inflammatory markers.

“While today’s approved drugs to treat diabetic neuropathic pain simply alleviate symptoms, they have a range of side effects and, unlike NB-01, do not address the underlying nerve damage in patients,” said Mark Versavel, MD, PhD, MBA, chief medical officer, NeuroBo Pharmaceuticals. “While our initial objective is to confirm the Phase 2 results on pain improvement, we believe that NB-01 has a strong potential to be a disease-modifying therapy, and we hope to differentiate our drug from other pain treatments with additional biomarker work to monitor and assess disease progression.”