|Re:gotta love the stealth move here, volume day like 2/12 prob sees $50|
7.95 8.03 adds..19.00..210K float still 19% short..one week now..NB-01
| Reply to SunTzu772 - Msg #71 - 04/06/2020 10:09|
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.