|Re: 7.95 8.03 adds..19.00..210K float still 19% short..one week now..NB-01 |
Overview of Current Clinical Pipeline
NB-01 – addresses a range of mechanisms that contribute to neuropathic pain and nerve degeneration in diabetic and other peripheral neuropathies. These include a decrease in key inflammatory markers, restoration of nerve growth factor (NGF) to normal levels, and reduction of advanced glycation end products (AGEs). NB-01 also reduces levels of TNF- and IL-6, both of which are markers of inflammation, which are implicated in diabetes-related complications. NB-01 also restores the neurotrophin NGF, which is involved in nerve growth, maintenance and repair.
NB-01 was developed primarily as a treatment for painful diabetic neuropathy (PDN), but NB-01 can also treat other neuropathic pain conditions, including chemotherapy-induced peripheral neuropathy and post-traumatic peripheral neuropathy. The global neuropathic pain market is currently estimated to be greater than $5 billion and is projected to grow to more than $10 billion by 2026. In the United States, there are currently only three FDA-approved treatments for PDN.
The company believes that NB-01 has the potential to offer pain alleviation with minimal side effects and to be potentially the first disease-modifying therapy impacting the underlying disease mechanisms. NB-01 has successfully completed two Phase 2 proof-of-concept clinical trials for PDN.
In addition to the pharmaceutical market to treat pain, there is a very large and growing market for nutraceuticals in this arena. Since NB-01 is derived from natural products, the company is considering marketing NB-01 as a nutraceutical (non-pharmaceutical) product.
NB-02 - has the potential to treat the symptoms of cognitive impairment and modify the progression of neurodegenerative diseases associated with the malfunction of a protein called tau, and with amyloid beta plaque deposition. NB-02 has shown considerable promise as a neuroprotective agent in preclinical studies, demonstrating a multimodal mechanism of action including inhibition of tau phosphorylation, acetylcholinesterase (AChE) inhibition, inhibition of A toxicity and amyloid plaque formation, and anti-inflammatory effects. The company intends to further leverage the benefits of tau modulation by NB-02 in conjunction with the other pathway effects to explore treatment of certain dementias such as the tauopathies.
The company believes that leveraging the therapeutic advantages of NB-02 will drive a paradigm shift in the treatment of Alzheimer’s disease and other neurodegenerative diseases. The company also is assessing whether to pursue further development of NB-02 as an orphan drug.
Gemcabene – is a novel, once-daily, oral therapy designed to target known lipid metabolic pathways to lower levels of LDL-C, hsCRP and triglycerides, that originally was licensed from Pfizer. It is in development for the treatment of dyslipidemia, a serious medical condition that increases the risk of life-threatening cardiovascular disease, focused on orphan indications such as homozygous familial hypercholesterolemia (HoFH), as well as severe hypertriglyceridemia (SHTG). Gemcabene has been tested as a monotherapy and in combination with statins and other drugs in more than 1,100 subjects across 25 Phase 1 and Phase 2 clinical trials and has demonstrated promising evidence of efficacy, safety and tolerability.
In August 2018, Gemphire announced that the FDA, following submission of its two-year rodent carcinogenicity study, had requested additional preclinical studies, including a 13-week PPAR knockout mouse study. The in vitro PPAR transactivation studies and subchronic study of Gemcabene in PPAR knock-out mice are completed, and the company is expecting to receive a response from the FDA in the second quarter of 2020 regarding removal of the partial clinical hold.
------------------- "Opportunities multiply as they are seized" -- Sun Tzu circa 500 B.C. -------------------
| Reply to SunTzu772 - Msg #69 - 03/26/2020 10:24|
Re: 7.95 8.03 adds..14.49..210K float still 19% short..one week now..NB-01
NB-01 210k float..
$9-$30 second time is a charm?
NeuroBo Pharmaceuticals to Initiate Phase III Clinical Trial of NB-01 in Adult Patients with Diabetic Neuropathic Pain
Published: Jan 08, 2019
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.