A medicine that could treat a series of incurable diseases? Ela Pharma is developing an innovative treatment for Necrosis,  which may revolutionize the treatment of  a long of diseases like heart attack, stroke, liver and pancreatic disease, gangrene in diabetes and pressure ulcers, age-related eye diseases such as macular degeneration, neurodegenerative diseases such as Alzheimer's and ALS – and mainly slowing down death processes and prolonging life.

 

There is one factor that stands behind countless diseases that cause suffering, and deterioration in the patient's medical condition - Necrosis. Until recently Necrosis has been considered an unregulated  process of cell death leading to organ and tissue death, involved  in a large number of diseases. Necrosis is an incurable phenomenon, and it can heavily bother and even lead to the death of those who suffer from it. Ela Pharma presents a paradigm shift in the treatment of Necrosis. It provides a solution to a large number of incurable diseases.

What is Necrosis?

Necrosis is one of the leading modes of cell death, which was considered an uncontrolled and inevitable form of death until recently. However, recent findings suggest that Necrosis is a programmed process  and thus can be treated. Necrosis is caused by a lack of blood or oxygen supply to the tissue, or other trauma that causes cell swelling,  disintegration of the cell membrane and leakage of cellular components into the environment.

Necrosis is almost always harmful and in many cases fatal. Necrotic cell death causes severe tissue damage in many clinical conditions, and there are no medicines to treat it. Currently, the only treatment for necrosis is hyperbaric oxygen therapy.

This is a complex procedure, in which the patient is inserted into a chamber, into which high pressurized oxygen is injected in order to increase the amount of oxygen flowing into the tissues. This is a process that requires the availability of special and expensive equipment, and its success in treating Necrosis and life prolongation is limited.

 

 

For example, currently, a person with a heart condition is rushed to the hospital for urgent treatment. However, from the moment a heart attack event begins, the cells start dying as a result of a lack of oxygen in the process of Necrosis. Each moment that passes is crucial to for  keeping the patient alive. Ela Pharma is developing a drug that will be given in such cases, as an initial treatment in an ambulance and intensive care units. The drug will stop the process of cell death - and in many cases will be the factor that saved the patient's life.

 

The revolutionary product developed by Ela Pharma is an anti-necrotic drug agent, based on small chemical molecules with specific structural characteristics. Using molecular technologies, Ela Pharma has identified key stages in the cellular development of Necrosis. Ela Pharma's development can monitor and neutralize the unwanted ?harmful cell death mechanism. This is a significant paradigm shift in the treatment of Necrosis, and it opens the door to treating dozens of different diseases that trigger this self-destructive process: Myocardial infarction, Ischemic heart disease, Stroke, Traumatic brain injury, Liver failure, Chronic hepatitis, Pancreatitis and Gangrene in diabetes and neurodegenerative diseases, such as ALS, Alzheimer’s and life prolongation.

 

Contribution to the COVID-19 War

The current coronavirus (COVID-19) epidemic mainly affects the lungs, but it also affects other organs. About 20% of patients are suffering of heart damage regardless of respiratory symptoms. Cardiac failure is the cause of death in COVID-19 patients - even those without severe breathing issues. There is also liver and kidney damage, as well as stroke, observed also in young people. Developing a drug to prevent Necrosis and heart damage can help in this fight. The company also has a patent for the antinecrotic activity of antitrypsin, which has antinecrotic effects in addition to a direct anti-infection effect for Covid-19.

 

One of the main developments the company is focusing on, may generate profit to investors quickly and addresses one of the most difficult problems of medicine today. Ela Pharma is developing a new solution for organ preservation to increase the shelf life of organs awaiting transplantation. Despite the significant advances in transplant medicine in the last generation, there are still serious problems in this field. The availability of vital organs for transplantation is very limited, in part because the most common methods for preserving living tissue are based on technologies that are 50-60 years old - and are limited in the contribution they are able to provide.

The World Health Organization (Geneva) estimates that only 10% of the worldwide need for organ transplants is met. Data shows that the shortage of organs for transplant is one of the biggest crises facing medicine in the world today. In the US, one in five patients awaiting transplantation has died due to this shortage. There are a number of factors responsible for this, but the main problem for these patients is the time the organ is able to live outside the body. This development is under a medical device regulatory path and can generate a much faster ROI.

 

 

Ela Pharma intends to use its innovative development in two phases - in the first phase, an organ preservation fluid will be developed, and released to the market within three years. Next, the company will develop specific treatments for myocardial infarction (AMI) and medications for chronic conditions, such as chronic heart failure (CHF) - which will be marketed in 2027-2029. This will enable further development of therapies to the long line of diseases mediated by necrosis.

 

No Effective Necrosis Treatment exists!

 

Why invest in Ela Pharma

• The company develops life-saving products that are of great value to humanity

• The development is suitable for application in the treatment of a wide variety of medical conditions and can be applied in the development of various drugs for specific conditions - which currently have no solution.

• High potential for quick profitability, through the marketing of the organ preservation Liquid (Medical Device)

• Already now there is significant evidence for the medical efficacy of Ella Pharma's products in preclinical trials.

• The company has registered patents in several countries.

• Product feasibility study was successfully done (POC) in several models in Israel and abroad. (Treatments for brain injury, heart attack, liver poisoning, pancreatitis)

• The company has begun a process of submitting grants to US organizations such as NIH and DARPA

• The Necrosis process is involved in a number of rare (orphan) diseases - that opens the door for rapid development pathway by the FDA - such as Liver poisoning by paracetamol or in rare tropical diseases such as Anthrax and others. This gives entitlement to Priority Review Voucher (PRV), which is transferable to drug companies, and thus worth many millions of dollars.

 

Milestones and goals

 

Ela Pharma aims to launch an organ preservation solution as early as 2023; A product for the treatment of Necrosis associated with myocardial infarction in 2027; And a product for the treatment of Necrosis associated with chronic heart failure in 2029. According to the plan, the pre-clinical phase of development is expected to continue until the end of 2023 - after which the clinical trials will begin, by the time the product is launched. The registered patents for the drugs currently being developed by Ela Pharma will expire in 2041 at the latest.

The company's goal is to generate profit in a short time - and take full advantage of the time the patents are registered under its name. The initial profit is expected to begin flowing soon, with the launch of the company's organ preservation fluid. At the same time, a portfolio of additional drugs for the treatment of other diseases will be developed by the company.

 

Market Overview

The global market for myocardial infarction treatments is expected to grow by about $1.99 billion through 2023-2019, growing at a rate of almost 5% per year. Further on, an increase in the availability of government financing programs, along with the expected approval of stem cell therapies for myocardial infarction - are expected to further encourage market growth.

Forecasts suggest that the global cardiovascular treatment market is expected to grow steadily, reaching about $70 billion in 2024. The increase in consumption of only five drugs will account for 50% of the growth in the entire market, so in the rest of the market, the growth will be felt less, as this is a mature field that is heavily based on generic drugs. However, many medical needs remain unanswered, as for most cardiovascular diseases no cure exists.

An examination of drugs launched into generic markets (Eliquis, Xarelto, and Entresto) shows how focusing on a specific patient population with unmet medical needs, produces significant gains.

Market for preservation solution:

The organ preservation market is poised to reach USD 241.2 Million by 2021, growing at a CAGR of 7.8%, during the forecast period of 2016 to 2021. However if new solution will be introduced which prolongs the lifetime  of organs  during preservation, the size of the market will be increases many folds.

The global market for myocardial infarction treatments

Competition

There are several noteworthy players in the myocardial infarction market, including AstraZeneca, Bayer AG, Bristol-Myers Squibb, Eli Lilly and Pfizer. Many of the competitors are already past the development stage, and their drug has already been launched.

In the heart failure market, there is a major leading competitor - Novartis' Entresto, which is generally considered to be the standard treatment. Entresto raises the level of certain proteins in the body, which can dilate blood vessels and prevent them from returning to their narrow shape - thus reducing blood pressure. Unlike the product developed by Ela Pharma, Entresto is not intended to eliminate the Necrosis process.

 

Production

The company will produce the materials for the clinical trial stages. The development stages will continue until the target date of launch. At the same time, the company has set the goal of creating strategic partnerships with manufacturers and distributors, in order to pass the drug production on to partners - and to maintain the company's focus on developing additional drugs.

 

Vision

Cardiovascular disease hurts the patient's quality of life and burdens medical systems worldwide. Ella Pharma's mission is to develop an effective, safe, and long-term treatment for Necrotic diseases in order to rehabilitate and save lives. Ela Pharma is developing accessible and user-friendly technology that stops the deterioration of tissues - by focusing on the right enzyme. With the products already in development.

Designation of investment funds

Ela Pharma is currently raising funds to complete the development of its pre-clinical heart attack medicine, and to advance the development of the organ preservation solution.

 

Crew members

Management team and consultants

Roi Paul Natan, CEO, Founder and Partner - holds a bachelor's degree in management from Ben Gurion University and a master's degree in business administration in the fields of entrepreneurship and strategy. Served as VP of Development and Import at Knitwork Production operating in US and in China. Holds vast expirience in strategy and business development in global corporations.

Prof. Emerita Ilana Natan, Founder and Partner - Prof. Emerita, Department of Clinical Biochemistry, Faculty Health Sciences at Ben Gurion University. Served as the delegate of the Israeli Ministry of Science in the European organization for cooperation in science and technology in the fields of biomedicine and molecular sciences. Served as consultant to Biopharma companies.

Dr. Yaakov Guy - Director of Research and Development: holds a degrees in Pharmacology, Immunology and Biochemistry. Over 25 years of professional experience in R&D management, QA/RA, auditing, project evaluation, patent analysis, pharmacology, product development, cell cultures and biochemistry.

 

Consultants

Prof. Amnon Albeck, Vice-Rector of Bar Ilan University, Organic/Medical Chemist. Known for his studies about the mechanism of action and inhibition, mainly of proteolytic enzymes such as elastase and rhomboids, drug design and peptidomimetics. Prof. Albeck is part of development from an early stage.

 

Dr. Aryeh Arish - General Surgery Specialist at Hadassah Medical Center in Jerusalem. Areas of treatment - liver, pancreas and bile ducts and liver transplants. Specialized for two years with Prof. Henry Bismuth at the Center for Liver Surgery in France, where he completed a subspecialty in liver, pancreatic, biliary and liver transplant surgeries. Headed the Department of Biliary surgery at Sheba Medical Center in Tel Hashomer. Since 2003 he has been a member of compagnons Hepato Biliaire, and since 2013 he has been a member of the National Academy of Surgery in France.

Member of the Israeli Society of Oncological Surgery in the Department of Ptobiliary Surgery and the Israeli Society for Liver Research.

 

Prof. Eli Lewis - Head of the Department of Clinical Biochemistry and Pharmacology, and Director of a Research Laboratory at Ben Gurion University, Faculty of Health Sciences. Member of medical and scientific associations such as the Transplant Society, the Cell Transplant Association, the International Transplantation Association - Xenograft, and the Pancreatic Transplant Association and Langerhans Cells. Research partner on the antinkrottin activity of antitrypsin – for which the company has the invention rights. Anti-coronavirus activity has recently been found for this protein.

Michal Shachar – An experienced R&D president with a proven history of working in the biotechnology industry. A research expert skilled in the development of pharmaceuticals, medical devices, biotechnology and the pharmaceutical industry.