Building an Affordable Drug for Diabetic Wounds

Theresa L O'Keefe, Ph.D.

Mend Therapeutics

$3,335Pledged
25%Funded
$13,743Goal
0Days
This project ended on:
5 May 2014
Mend Therapeutics is creating AFFORDABLE drugs for the World’s 371 Mill diabetics who don’t have health insurance. Diabetic complications are catastrophic and include non-healing wounds leading to amputation. We want to develop a protein for diabetic wounds that can be manufactured at low cost, an important step in creating an affordable drug. If all patients, irrespective of economic status, can afford medications, they have a brighter future.

What is the context of this research?

Diabetes is a chronic disease affecting over 371 million people around the world, most in low or moderate income countries. The vast majority of people with diabetes (80%) do not have health insurance, so they and their family must bear the cost of their care alone. Unfortunately, many people with diabetes develop life-threatening complications that require expensive treatments. The financial and personal costs of diabetic complications can be overwhelming.

Diabetes is a number of disease in which the person cannot properly control their blood glucose. When blood glucose levels remain high for too long, it leads to complications including blindness, kidney failure, nerve damage and heart attacks. It can also block normal wound healing. 15 – 20% of people with diabetes develop wounds on their feet and lower limbs that don’t heal well. There are treatments but they are labor intensive and expensive. For many people treatments are delayed due to cost. If treatments fail to promote wound healing, the only option is amputation. This happens about 30% of the time. Unfortunately, that is not the end. Within 3-5 years, 50% of the diabetic amputees have died. A better option is to have a safe affordable treatment that can and will be used early when the wounds have the greatest chance to heal. Mend Therapeutics want to develop such a treatment.

Wound healing research has created a experimental protein that shows potent ability to overcome defects in diabetic wound healing. Unfortunately, the experimental protein is expensive to produce and thus cannot become an affordable treatment. Using our extensive drug development experience, we designed synthetic candidates that should retain the wound healing capabilities of the original experimental protein but can be manufactured at a very low cost. Low cost production combined with Mend Therapeutics’ non-profit status means Mend Therapeutics will be able to deliver at the lowest possible prices. a new potent drug to the people who need it most.

What is the significance of this project?

Mend Therapeutics wants to start a Global revolution with a non-profit drug company that develops new, first-in-class drugs offered to patients at affordable prices irrespective of a patient’s economic status. We believe everyone, not just the wealth, should have access to effective therapeutics.

Our mission is to globally eradicate complications of diabetes. We have extensive experience developing successful drugs and intend to use our deep knowledge of drug development to make significant change in the lives of people with diabetes by creating new medicines that are truly affordable.

All patients deserve access to high quality drugs. Currently, new drugs are developed by for-profit companies at astronomical costs. To recoup their investments, drugs are sold at the highest price possible to those patients who can afford them or have insurance to cover the cost. Only after the patent expires (>10 years) will most patients be able to afford access to the best treatments.

Diabetes is an enormous and growing problem around the world. It is estimated that by 2030 over ½ Billion people will be living with diabetes, most in low- or middle-income countries. As most have no health insurance, the patients and families bear the costs themselves. The families are forced to choose between loved-one’s health and the family’s economic devastation. With affordable treatments, patients and their families can have both.

This project is the first giant step on our journey to create a potent therapeutic at an economical price. This step, creating a low cost manufacturing process, is critical if Mend Therapeutics to provide MT-003 to patients at lowest possible cost. To do this we must raise money from enthusiastic supporters and donors who believe in our vision and our mission.

What are the goals of the project?

We need to develop a new treatment for diabetic wounds that is safe, effective and importantly, can be manufactured at a low cost. This low cost production is critical if the future drug, which we are currently calling MT-003, can be provided to all patients who need it, without bankrupting their families.

This research project aims to find a low cost way to manufacture a therapeutic protein drug (to be called MT-003) while retaining the wound healing properties of a experimental protein. Although the experimental protein has shown great promise in wound healing models, it is too expensive to produce on the large scale needed for the many diabetic patients around the world who need it.

For this research, we will focus on two versions of MT-003, which we believe have the greatest potential to promote wound healing while also providing production at an affordable price. In this project we will also produce small quantities of the two versions of MT-003 so we can determine their wound healing capabilities. With the data obtained through this research project, we will have developed critical information about how to manufacture MT-003 economically. This is a first and critical step if Mend Therapeutics is to help more than 50 million diabetic patients every year who can’t afford expensive treatments for their chronic diabetic wounds. We want to save them from unnecessary amputations.

The Goals Are:

  1. Synthesize genes for two candidate proteins (MT-003-Version 1 and MT-003-Version 2) and clone the genes into different expression vectors
  2. Insert completed plasmids into several different bacterial strains
  3. Evaluate different growth conditions to the select highest rates of protein production
  4. Conduct small scale protein purification optimization
  5. Scale up production and purification to isolate approximately 5 mg of each synthetic protein.

    If extra funds are raised:
  6. Use cell assays to determine which version of MT-003 is best at promoting normal wound healing.

With the data obtained through this research project, we will have critical information about how to economically manufacture a potent wound healing therapeutic protein drug.

Budget

Budget Overview

100% of our budget will be used to purchase supplies and conduct the necessary lab work to develop the low cost manufacturing process and produce small quantities of the two candidates. The project can be divided into 3 phase, each utilizing approximately 1/3 of the funding. The first phase involves creating the production system; the second phase involves determining the best protein purification process and the third phase involves manufacturing 5 mgs of each candidate to be used in functional assays.

Meet the Researcher

Background

Dr. O’Keefe developed protein drugs for multiple companies include Pfizer, Critical Therapeutics, Millennium and LeukoSite. She also was Scientific Advisor for Pharma-Cycle, a company focused on cancer prevention in family members of patients undergoing chemotherapy. Dr. O’Keefe has > 15 years of biotech and pharma drug development experience as well as 10 years of academic research during which she co-authored tier 1 papers and co-invented > 30 patents and patent applications. Highlights include Millennium’s antibody expression system and Entyvio, Millennium’s antibody for Crohn’s and Inflammatory Bowel Disease currently under FDA review. She spent 6 years at the Medical Research Council Laboratory of Molecular Biology, Cambridge UK working with Drs. Michael Neuberger and Caesar Milstein (Nobel 1984). She co-founded Mend Therapeutics because she believes everyone should have access to the best therapeutics possible, irrespective of their ability to pay.


Endorsed by

RobertObar

Theresa O’Keefe is a creative and passionate scientist, with a long history of accomplishment in drug development. ...See more

Director of Drosophila Proteomics, Major University Medical School and Consultant, Biogen Idec

barbaratate

Mend Therapeutics has an innovative and patient centric approach to developing and delivering life saving medications...See more

Drug Development Expert

mandrekp

I am confident that Dr. O’Keefe and her colleagues at Mend Therapeutics will make a difference to the diabetic...See more

Professor, UMass Medical School


Press

Mend Therapeutics www.mendtherapeutics.org

Diabetes is a world-wide disease with an ever growing personal, family and economic impact. The International Diabetes Federation (IDF) published Atlas to cover the statistics of the enormous burden diabetes puts on families around the world. The IDF is an umbrella organization of over 200 national diabetes associations in over 160 countries.

International Diabetes Federation Atlas 2014
http://www.idf.org/sites/default/files/da5/Diabete...

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Categories

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