Phase 3 Trial of Dioscorea japonica Extracts To Be Initiated for Treatment of Pain From Diabetic Neuropathy
The planned initiation of a phase 3 double-blind, placebo controlled, 12-week study of Dioscorea japonica extracts (NB-01; Neurobo, Boston, MA) for pain relief in patients with diabetic neuropathy has been announced. The trial is expected to begin in the second quarter of 2019 and will randomly assign approximately 717 adults with diabetic neuropathic pain to receive the extracts or a placebo. A second pivotal phase 3 study is also planned for 2020. Both studies will measure a change in weekly mean of daily pain scores on the 11-point Pain Intensity Numerical Rating Score (PI-NRS) using an electronic patient diary. The trial will also measure number of responders on the Patient Global Impression of Change Scale (PGIS).
In previously conducted phase 2 trials, Dioscorea extracts showed high efficacy in pain reduction with minimal to no side effects vs placebo. Preclinical studies have demonstrated that Dioscorea extracts inhibit advanced glycation end products (AGEs) and inflammatory markers and increase release of nerve growth factor (NGF), stimulating nerve growth.
Mark Versavel, MD, PhD, MBA, chief medical officer, NeuroBo Pharmaceuticals 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. 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.”