NeuroBo Pharmaceuticals to Initiate Phase III Clinical Trial of NB-01 in Adult Patients with Diabetic Neuropathic Pain

January 8, 2019 |

4 min read

Pivotal Phase III study will further evaluate the efficacy of candidate NB-01 on pain associated with diabetic neuropathy

BOSTON--(BUSINESS WIRE)-- 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 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.”

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 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.”

Further Advancements in NeuroBo Pharmaceuticals’ Pipeline

NeuroBo’s second candidate, NB-02, is an IND-ready neuroprotective drug that targets Alzheimer’s Disease. In preclinical studies, NB-02 has demonstrated inhibition of amyloid beta (Aβ) deposition and of tau-phosphorylation, as well as reduction of acetylcholinesterase activity and decrease of inflammatory markers. Recent work on NB-02 was presented at the Society for Neuroscience annual meeting in a session titled “Alzheimer’s Disease and Other Dementias: Therapeutic Strategies: Preclinical Cellular Models” by a research group from Massachusetts General Hospital and Harvard Medical School. This group previously reported that NB-02 arrested amyloid plaque deposition and decreased the number of neurons with elevated intracellular calcium levels in a genetic mouse model. Their recent studies showed that NB-02 prevents the increase in calcium overload in primary neurons and astrocytes caused by amyloid-β oligomers. The group concluded that NB-02 has great promise as a potential therapeutic for Alzheimer’s disease. Additional work is being planned to characterize the multi-mechanistic effects of the drug and to design a Phase IIa clinical trial in mild to moderate stages of the disease.

About NeuroBo Pharmaceuticals

NeuroBo Pharmaceuticals is focused on novel treatments for neurodegenerative diseases that affect millions of patients worldwide. The company’s novel lead candidate NB-01 is a potential treatment for diabetic neuropathic pain. Its second drug compound focuses on Alzheimer’s disease currently ready for an IND and Phase IIa trial. NeuroBo Pharmaceuticals was jointly founded by JK BioPharma Solutions, a company specializing in the development of new biopharmaceuticals, and Dr. Roy Freeman, a Professor of Neurology at Harvard Medical School, to develop natural product-based ethical medicines and is headquartered in Boston, MA. For more information, visit https://www.neurobopharma.com.

About Dong-A ST

Dong-A ST, founded in 1932, is a leading pharmaceutical company specializing in discovery, development, manufacture and marketing of pharmaceutical products and biosimilars. Dong-A ST’s strength in R&D resulted in 6 new, in-house developed product launches within Asia and a once-daily antibiotic approved in the US, EU and Japan. Dong-A ST has a strong R&D division, especially in immuno-oncology and epigenetics, and such capabilities enabled Dong-A to get partnered for licensing/co-research with several global pharma companies or companies specializing in these areas. Dong-A ST is headquartered in Seoul, South Korea and listed on the Korean stock exchange. For more information, visit http://www.donga-st.com.