NeuroBo Pharmaceuticals to initiate Phase III clinical trial of NB-01 in adult patients with diabetic neuropathic pain

Source: CBNB


Source: Company press release, 8 Jan 2019 , 8 Jan 2019 , Website: NeuroBo Pharmaceuticals Inc, a clinical-stage biotechnology
company focused on novel, disease-modifying therapies for neurodegenerative
diseases, announced on 8 Jan 2019 its plans to initiate a Phase III trial to
evaluate the efficacy of its lead drug, NB-01, in diabetic neuropathic pain
in early 2Q 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 RandD originally conducted by
Dong-A ST, a major Korean pharmaceutical company. NB-01 has previously shown
successful Phase II 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 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 1H 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. Original Source:
Moderna Inc, 2019. From website: Released to ICIS 12 Feb 2019[This article was prepared by Chemical Business NewsBase (CBNB), a third party premium option available through ICIS news. For any queries about the content please contact: John Godfrey,, +44 (0) 1223 463167]