We hope this finds each of you and your families safe and healthy. We are pleased to update you on the status of our projects and initiatives, which we are happy to report are all running on time, and producing the anticipated positive results necessary to bring our drug to market. When we complete the studies requested last year by the FDA, EmeraMed will file a new drug application (NDA), which then starts the FDA approval process.
Boyd E Haley, PhD, CEO
Exploring NBMI’s unlimited potential
EmeraMed is rapidly completing the requirements for US FDA New Drug Application (NDA). Despite some minor setbacks during the Covid-19 pandemic we still anticipate to manufacture the FDA required registration batches before the end of 2020 and filing the NDA late 2021 once we have 12 months stability data (as required by the FDA). Then the ball will be in the FDA’s court and we expect their review process to take another 6 months. In the meantime, we are engaged in expanding the clinical trials of disorders that NBMI can potentially improve.
In Colombia, South America the drug regulatory agency INVIMA has approved a large pivotal study for mercury intoxication which we began in May 2020. The treatment will be much longer than our earlier trials with gold miners and will look at numerous physiological parameters. The major advantage is that the Colombian subjects will not be continuously exposed to high levels of mercury vapor as was the case with the gold mine workers. We are preparing the final contract with the primary care facility now and to import NBMI into the country. The kidney dialysis clinic has identified the mercury from fish in the Santa Margareta river as one potential source for kidney injury leading to dialysis treatment. It will be a double blind placebo controlled pivotal study, the participants health and results will be carefully monitored.
We know that their urinary mercury will drop sharply as it has in all the other trials but it will also answer the question does that also translate to improved kidney function in humans as it does in animals? As they say in the movies we’ll soon find out. The Colombian INVIMA has approved us begin this pivotal trial as both mercury intoxication and kidney disease are a serious life-threatening intractable condition and prominent in Colombia. The trial is strongly supportive because everyone would be delighted to offer hope of a return to normal life instead of lifelong needles, tubes and machines.
The minister of health declared that mercury was a public health emergency in the Porto Colombia area and that declaration has given INVIMA added incentive to move forward with this expanded clinical trial. We expect the cost to be around $1M. If we produce the desired results we intend to apply for market authority in Colombia shortly thereafter. Since all health care is paid for by the government the majority of sales of our compound would be directly to the government. Colombia has a total program to address mercury intoxication but it is severely handicapped by the utter lack of safe and effective chelators for mercury. We expect the ministry of health will shift their program to embrace widespread use of NBMI especially if we, as is our intention, keep the price as affordable as possible.
In speaking with possible investors in EmeraMed there are so many avenues to profitability that it is difficult for many to wrap one’s head around them. The diagram below shows in general where this is all headed and what is done, needs doing or is planned and applies a dollar figure to each avenue. Obviously, the projections are based on assumptions (i.e. no COVID-19 pandemic) regarding development and regulatory plans and outcomes, timing, costs, pricing and revenues and should be regarded with caution as we cannot guarantee their accuracy. Not all avenues have been explored so we believe that, in time, the potential will be greater than shown.
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The short list of potential applications for Emeramide®
As the chart shows we’ve divided the potential uses into two major categories: drugs and everything else. Our current focus is to complete the drug applications but not to the exclusion of some low hanging fruit. Environmental clean-up may at some point become a best seller depending on how enthusiastic the world is about healthy drinking water, rivers, lakes and streams. Arsenic (As) in drinking water is a well-recognized problem but since it is very difficult to remove, EPA maximum drinking water standard allows drinking water to have arsenic levels that cause significant amounts of bladder and lung cancers. We can fix that by pre-treating raw water with a percolation bed or in some fashion bring the Arsenic in contact with NBMI. In addition, the resulting water would also be cleansed of all the other heavy metals NBMI captures. Studies on metal binding have shown that NBMI is strongly attracted to Mercury, Arsenic, Lead, Cadmium, Uranium, Gadolinium and free iron and copper. The unbound (free) Fe2+ and Cu2+ redox metals are produced when toxins that induce oxidative stress are the cause of illnesses.
Toxins (like Hg2+, Cd2+, Pb2+ and certain pesticides, herbicides and viruses) induce oxidative stress by displacing these two essentials redox metals which, when unbound, after displacement from their natural state, can catalyse by the Fenton Reaction very large amounts of very toxic hydroxyl free radicals that can lead to illness and death. The compound will also improve treatment of waste water sewer sludge to remove mercury or other toxic metals before it is spread on farms. These uses will hinge on FDA and CMC approval.
Excess iron causes many devastating disorders, some lethal. We have begun two pilot studies in Europe on iron. Atypical Parkinson, an always fatal disease, is partially finished. We expect to receive an interim report by July 2020 on a Thalassemia study that shows a highly significant benefit from NBMI. 8 out of 8 improved without any reported drug induce toxic side effects. “Impressive” in the words of one reviewer.
Beta-Thalassemia’s iron overload comes from frequent blood transfusion. This is true of any condition requiring repeated blood transfusions which considerably expands NBMI’s market reach. As Dr. Haley has explained free iron induces oxidative stress and anyone who gets a blood transfusion more than a few times will eventually be stressed with excess iron. NBMI can help in two ways. One it will quench existing oxidative stress by scavenging hydroxy free radicals and also by irreversibly binding free iron into a chemically inert, very stable non-toxic complex for removal by the P-450 detox system.
After NBMI is an approved safe and effective drug we can approach blood banks to encourage them to improve the quality of transfused blood before it is injected into the patients. Medical laboratory uses are yet another avenue for profit.
Excess oxidative stress causes many disorders especially in smokers and thought to be due to Cd2+ toxicity. In the small pilot study on advanced cases disappointingly only 2 showed improvement likely due to their advanced state. COPD is widespread and would be a tremendous benefit to the company, but it will be one of the costliest indications. So as the flow chart shows we have paused development for the moment but at the same time added COVID-19. Also, the use of NBMI to treat less serious COPD patients by compassionate use has lead to impressive recoveries in two such patients.
Research by other laboratories has shown that increasing reduced glutathione (GSH) levels is a preventive against flu and H1N1 viral replication and virulence. Dr. Haley gave a presentation on this to the IAOMT. Since Emeramide has been shown to increase the red blood cell GSH levels in human subjects we proposed that treating viral susceptible patients, such as the elderly and those with underlying medical issues, with Emeramide would be a practical study since it is a drug with few, if any, adverse effects at the levels required. The mechanism of action is based on the ability of Emeramide to: 1; enter cells and cross the blood brain barrier, 2; scavenge and remove existing hydroxyl free radicals lowering oxidative stress and 3; chelate into non-reactive and non-toxic complexes several toxic metals and most importantly Fe2+ a redox metal that has been proposed to be displaced from hemoglobin by the COVID-19 infection.
We have submitted our application to the FDA committee charged with evaluating such proposals, BARDA and they are under review at this time. We even had a letter delivered to Vice President Pence’s #2 assistant, who suggested we submit it to the republican party in Kentucky. FYI we had already done that and had made direct presentations by mail or email to all relevant Kentucky State and Federal congressmen.
Simultaneously in Colombia SA we began collaboration on a COVID-19 Phase II study with a university to design a large clinical trial on exposed health care workers. Our involvement won’t be a financial burden because all we will need to provide is NBMI. We know NBMI would help because viruses need to release free iron to be able to reproduce. That iron causes oxidative stress possibly leading to a cytokine storm.
Although early access in the US and Canada continues to be a bureaucratic nightmare several people in US have received the 4.2 grams of Irminx (API is emeramide) allowed by FDA regulations. None so far in Canada. Other areas of the world, especially New Zealand, and Switzerland have been much more receptive to NBMI and although this usage continues to grow it is revenue neutral since we cannot charge a profit for the compound. Nevertheless, we are getting good reports on treatment and learning about many disorders that improve with chelation therapy. Of particular interest was a young female injured by gadolinium MRI contrast agent. Her life had become intractable with significant joint pains as a result of this heavy metal. She says, “NBMI saved her life”.
The next newsletter is scheduled to be out in late summer before our annual investors meeting and Drs. Haley and Kennedy host a small investors open house in Nashville at the IAOMT. Many of our investors are members of the IAOMT. By that time we will have data from several of these studies including the interim report on Thalassemia. We will host the annual meeting with a secure video conferencing program GoToMeeting. It can have up to 150 participants. We would like every investor who can to attend. It is your company and we have the team that will bring home success.
The Company & The Drug Emeramide®
EmeraMed Ltd is an Irish biotech company with subsidiaries in the USA and Sweden that is developing Emeramide®, a metal chelator and antioxidant. Emeramide® is a drug/chelator/antioxidant that, upon binding, immediately eliminates the toxicity of metals such as mercury, lead, cadmium, arsenic, as well as free or unbound iron-copper-zinc.
Thank You For Your Support
EmeraMed’s strategic and focused efforts to achieve market approval, as described in this Newsletter, are moving the company ahead rapidly. We are working diligently to insure that Emeramide® will soon benefit people worldwide as an effective and safe drug for a range of diseases and conditions that lack efficient treatment, and we will keep you updated by our newsletter on EmeraMed’s progress to develop Emeramide® as an approved drug globally.
Thank you for your continuing support.
The Board of EmeraMed
Boyd Haley, CEO
Lexington, Kentucky, USA