NB-01 / Dong-A, Mthera Pharma - LARVOL DELTA

NeuroBo licenses NB-01 to MThera Pharma for diabetic neuropathy treatment (Korea Biomedical Review) - "MThera Pharma...said that it has signed an exclusive licensing agreement with NeuroBo Pharmaceuticals, a subsidiary of Dong-A ST, for the development of the latter’s NB-01 (DA-9801) as a candidate for treating diabetic neuropathy. However, MThera Pharma did not disclose the financial details of the agreement, citing contractual reasons. MThera Pharma will lead the research, phase 3 clinical trials, and commercialization of NB-01 both in Korea and the U.S."

Licensing / partnership • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

NeuroBo Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update (PRNewswire) - "...Signed a term sheet with MTHERA to out-license the worldwide rights, excluding Korea, for NB-01, for the treatment of painful diabetic neuropathy, and allowing MTHERA to conduct research in order to seek new patents for NB-01 and conduct clinical trials, including, but not limited to, a potential Phase 3 clinical trial in the United States for the future commercialization of NB-01."

Licensing / partnership • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Could consumption of yam (Dioscorea) or its extract be beneficial in controlling glycaemia - A Systematic Review. (PubMed, Br J Nutr) - "All ten studies showed that consumption of yam and/or its extract (containing dioscin, dioscorin, diosgenin, DA-9801/02, or Chinese yam polysaccharides) improved glycaemia...The current work indicates that the consumption of yam or its extracts can be beneficial for improving blood glucose however the molecular mechanism for these effects remain largely unknown. Future trials on human subjects are warranted."

Journal • Review • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Effects of DA-9801 on the inflammation and apoptosis induced by angiotensin II in human dermal microvascular endothelial cells. (PubMed, J Pharmacol Sci) - "Moreover, TUNEL and annexin V-FITC fluorescence staining for apoptosis and the activities of caspases 9, 7, and 3 decreased in HDMECs pretreated with DA-9801, indicating that the drug enhanced anti-apoptotic pathways. Thus, DA-9801 modulated Ang II-induced endothelial cell dysfunction via inflammatory and apoptotic pathways."

Journal • Diabetic Neuropathy • Immunology • Inflammation • Pain • CASP9 • ICAM1 • NFKB1

Samsung Securities ‘Dong-A ST’s 1st quarter surprise results… 2Q deficit’ [Google translation] (Maekyung Media Group) - "Samsung Securities [016360] predicted that Dong-A ST [170900] will make a surprise performance (earning surprise) in the first quarter, but will show a deficit in the second quarter....'Don-A ST's separate base sales in the first quarter increased by 42.5% compared to the same period last year to KRW 233.3 billion, and operating profit increased by 90.4% to KRW 39 billion. 159.1% will exceed.'"

Sales

NeuroBo Pharmaceuticals reports year end 2019 financial results and provides corporate strategic update (PRNewswire) - "With...the global health emergency caused by the COVID-19 pandemic, we have recently taken a number of prudent strategic steps...We have decided to postpone the initiation of Phase 3 clinical trials for NB-01....Consequently, in the first quarter of 2020, we ceased work on Phase 3 trials for NB-01 and gave notice of termination of all related contract arrangements with our contract research organizations....Although NB-02 is almost ready for the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), we intend to postpone our first-in-human clinical trials until market conditions improve."

IND • Licensing / partnership • Trial status

DA-9801, a standardized Dioscorea extract, improves memory function via the activation of nerve growth factor-mediated signaling. (PubMed, Nutr Neurosci) - "Mice with DA-9801 administration showed memory enhancement in the passive avoidance test. DA-9801 also increased newborn cell differentiation, neurite length, NGF secretion, and ERK/CREB phosphorylation in the mouse hippocampus. These results suggest that DA-9801 treatment could improve memory function by inducing hippocampal NGF synthesis and ERK/CREB signaling."

Journal • NGF

Dong-A ST posts robust profit in 2019 (Korea Biomedical Review) - "The company said that it has completed its U.S. phase 2a clinical trial for DA-9805, a Parkinson's disease treatment...Also, the company plans to complete its local phase 1 clinical trial for DA-5207, a weekly patch-type dementia treatment, in the first half of this year. At the same time, it has received approval to conduct a phase 1 clinical trial for the drug candidate in India. It said DA-9801, a diabetic neuropathy treatment licensed out to NeuroBo, will be tested soon in a phase 3 trial in the U.S."

New P3 trial • Trial completion • Trial status

NeuroBo Pharmaceuticals and Gemphire Therapeutics complete merger (Businesswire) - "Initiation of enrollment in the first Phase 3 study with NB-01 is anticipated in the first half of 2020 and will enroll approximately 460 subjects with PDN across the U.S."

Enrollment status • New P3 trial

Gemphire Therapeutics and NeuroBo Pharmaceuticals Announce Merger Agreement to Advance a Neurodegenerative Disease Company (GlobeNewswire, Gemphire Therapeutics Inc.) - "Gemphire Therapeutics Inc....today jointly announced that they have entered into a definitive agreement whereby NeuroBo will merge with a wholly-owned subsidiary of Gemphire in an all-stock transaction....NB-01 has successfully completed Korean and U.S. Phase 2 proof-of-concept clinical trials, showing that NB-01 provided significant relief of diabetic neuropathic pain with minimal side effects, compared to placebo. Phase 3 clinical trials are expected to begin in the fourth quarter of 2019."

Clinical data • Commercial • New trial