NephroGenex ($NRX) is a pharmaceutical company focused on the development of therapeutics to treat kidney disease, an area of significant unmet medical need.
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NRX scheduled a
Manager, Joint managers:
The product appears to be a sooped up derivative of the vitamin B6. NRX is doing clinical studies rather than clinical trials.
Cash burn rate: when a company loses money with minimal depreciation & amortization (think biopharmas), the negative Price/Loss ratio is an indication of cash burn rate. The higher the loss the lower the absolute (negative) ratio. The lower the loss the higher the absolute (negative) ratio.
Rating is neutral-to-negative, clinical studies not trials, shareholders not buying, relatively low cash burn rate.
NRX is a pharmaceutical company focused on the development of therapeutics to treat kidney disease, an area of significant unmet medical need.
Pathogenic oxidative chemistries are collectively a group of oxygen-based chemical reactions that occur in the body during stress, injury, or disease, to form compounds that can induce pathological changes in tissues that effect normal physiological function.
These include (i) advanced glycation end-products (AGE's), which are oxidative end products of glucose-modified biomolecules which adversely affect their function; (ii) reactive oxygen species (ROS), which are chemically reactive molecules containing oxygen such as oxygen ions and peroxides that when elevated in the body can induce pathology; and (iii) toxic carbonyls which are reactive compounds that can modify biomolecules and affect their function.
These chemistries are generally agreed to be involved in the etiology of diabetic nephropathy, a common complication of diabetes. NRX ise developing Pyridorin(TM) ("Pyridorin"), a small molecule drug that is a unique and broadly acting inhibitor of the pathogenic oxidative chemistries which are elevated in diabetic patients.
Lead product candidate
The oral form of Pyridorin (pyridoxamine dihydrochloride) is being developed as a chronic, therapeutic agent to slow the progression of diabetic nephropathy.
Pyridoxamine is a derivative of vitamin B6 and consists of a different chemical structure. It uniquely possesses activity against a broad range of pathogenic oxidative chemistries, a generally agreed causative factor in the development and progression of diabetic nephropathy.
Clinical studies & trials
NRX licensed patents covering methods of use and synthesis of Pyridorin from
At the time of acquisition, BioStratum, through its contracted investigators, contract research organizations, and collaborators had completed 5 preclinical efficacy studies, 36 preclinical safety studies, 4 Phase 1 studies and 5 Phase 2 studies with Pyridorin. After the acquisition, we conducted a multi-center, randomized, placebo-controlled Phase 2b study, namely PYR-210.
In addition, NRX worked with the
Based on these results, Pyridorin will be further developed in a Phase 3 program agreed to by the
NRX owns patents covering methods for using Pyridorin to treat diabetic nephropathy in patients with type 2 diabetes and elevated levels of SCr, and thus closely track the anticipated drug label for an approved Pyridorin drug.
These patents consist of an issued U.S. patent (U.S. Patent 8067444) and corresponding issued patents in
The biopharmaceutical industry is characterized by intense competition and rapid innovation.
Although NRX believes that Pyridorin is one of the few drug candidates in advanced clinical trials for diabetic kidney disease, its competitors may be able to develop other compounds or drugs that are able to achieve similar or better results. NRX's potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.
NRX believes the key competitive factors that will affect the development and commercial success of its product candidates are efficacy, safety and tolerability profile, reliability, convenience of dosing, price and reimbursement.
Care Capital III, LLC? 59.9%
Funds affiliated with Rho Ventures? 23.1%
BioStratum, Incorporated? 9.4%
Use of proceeds
NRX expects to net
the remainder for general corporate purposes, general and administrative expenses, capital expenditures, working capital and prosecution and maintenance of its intellectual property.