NeuroBo Pharmaceuticals is set to begin a Phase III trial to analyse the efficacy of NB-01 for the treatment of diabetic neuropathic pain in the second quarter of this year.
The double-blind, placebo controlled, 12-week study is expected to randomise nearly 717 adults patients at up to 80 sites in the US.
NeuroBo also intends to start a second global pivotal Phase III study of NB-01 with a similar design in mid-2020.
The primary goal of both trials is a change from baseline to week 12 as measured by the weekly mean of daily pain scores using an electronic patient diary.
Key secondary goals incude the number of patients who respond to the patient global impression of change scale (PGIS), defined as ‘much improved’ or ‘very much improved’.
The trial plans to carry out an interim analysis of its results in the first half of 2020 and is scheduled to be completed by 2021.
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NeuroBo Pharmaceuticals president and CEO John Brooks III said: “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.
“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 demonstrated positive results in treating diabetic neuropathic pain in a previous Phase II trial by showing a high efficacy in pain reduction with minimal to no side effects against placebo.
NeuroBo Pharmaceuticals chief medical officer Mark Versavel said: “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.
“While our initial objective is to confirm the Phase II 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.”
NeuroBo Pharmaceuticals is primarily involved in the development of treatments for neurodegenerative diseases.