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May 18, 2015 Issue

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Commercializing Novel Products for Type II Diabetes Treatment

 


Dr. Bruce Markham, PhD

President & CEO

 

Diapin Therapeutics

www.diapin.com

 

Interview conducted by:

Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – May 18, 2015

 

CEOCFO: Dr. Markham, would you tell us the concept behind Diapin Therapeutics?

Dr. Markham: The company was formed to commercialize novel products for treatment of Type II diabetes.

 

CEOCFO: What have you created?

Dr. Markham: We have a three-amino acid peptide that stimulates a G-protein-coupled receptor to lower blood glucose both in the acute and chronic settings in animal models. The target of our lead peptide is a G-protein coupled receptor that has not yet been recognized in the literature as a target for Type II diabetes treatment.

 

CEOCFO: How did you find it?

Dr. Markham: The peptides were originally discovered in Dr. Eugene Chen’s lab. The idea came from looking at the amino acid composition of gelatin. There were several small peptides. If you take it before having a meal, gelatin has been shown to be able to control blood glucose. Dr. Chen and his colleagues tested several peptides that could be found in gelatin digestions and found five peptides that he tested and our lead molecule is the best one of these at glucose lowering.

 

CEOCFO: What part of diabetes control does your process help?

Dr. Markham: Our peptides are glucagon-like peptide-1 and insulin secretagogues. In other words, they stimulate secretion of those peptides from their respective cell types. Glucagon-like peptides-1 is produced and excreted from endocrine-L cells in the gut and insulin from the pancreatic beta cells. We have shown that this increases both insulin and glucagon-like peptide-1 in vivo as well as in cell culture, both in cell lines and primary cells.

 

CEOCFO: Have people been looking at this particular approach?

Dr. Markham: Glucagon-like peptide-1 or GLP-1 is one of the incretin peptides. GLP-1 analogues or GLP-1 itself are now some of the newest up and coming therapies for treatment of Type 2 diabetes. Also, DPP-4 inhibitors like Januvia prevent the breakdown of GLP-1. There are other therapies that work on this mechanism, but there are some very significant side effects associated with these therapies in patients. We think that being able to take a pill once a day rather than having an injection once a day with GLP-1 or GLP-1 analogues will be something that patients will prefer. We expect this to be much more efficacious than DPP-4 inhibitors.

 

CEOCFO: How can you test to be certain of these drugs?

Dr.: The latest drug class for diabetes that has had problems is the Thiazolidinediones such as PPARy (gamma) agonists, Actos and Avandia. They have been shown to have some significant cardiovascular risk associated with taking those drugs. We will certainly do the standard safety pharmacology testing in two animal species that the FDA requires. That is something that everybody has to do to get into the clinic. Our peptide is three amino acids. We will have an enteric coating around that peptide to slow the degradation in the stomach because we want to deliver this to the small intestines. The enteric coating has been tested and is being used with several different drugs. We have three naturally occurring amino acids and your body is exposed to the three amino acid peptides when you eat Jello, steak or any protein product. We will look for not only specific mechanism related toxicities but also off-target toxicities as well.

 

CEOCFO: What are the next steps?

Dr. Markham: Diapin has received pre-seed funding from our partner in China, which is Beijing SL Pharmaceuticals. We are in discussions with several large pharma companies under CDA as well as an investment arm of another Chinese company. We expect to raise somewhere in the neighborhood of about $10 million to finish activities for our IND or find a corporate partner. We have had discussions with those corporate partners and they have told us some of the studies they would like to see in order to convince them that this is something to look much more carefully at and be involved. We hopefully, have investment or a corporate partner by the end of this year.

 

CEOCFO: How did the partnership with China come about?

Dr. Markham: Dr. Mingbo Xu, who is the president and CEO of Beijing SL Pharmaceuticals is a personal friend of our founder Dr. Eugene Chen. They went to school together in China and they have kept their relationship going. Dr. Xu has put money into Dr. Chen’s lab on occasion to see certain research get done. When Dr. Chen formed this company with my help he talked to Dr. Xu and he was interested so he initially put in $2 million and just recently put in another million to keep the work going while we are looking for additional funding.

 

CEOCFO: Would you tell us about the recent patent you were awarded?

Dr. Markham: We actually have two issued patents now. They both came off the initial intellectual property filed by the University of Michigan. The first patent that we got was for the oral dosage form of these five peptides. We have the rights to use these peptides in any disease and the right to defend that. We just recently got a method of use patent for the treatment of Type 2 diabetes with these peptides.

 

CEOCFO: What have you learned from previous ventures, both on the scientific side and business side that has been helpful to Diapin?

Dr. Markham: The first thing that was helpful was my initial contact with venture capital firms and getting to know a few of those people. That has helped me get in the door. I have a couple of venture capital firms that said they would be very interested in this project once we have our IND enabling tox completed. The other thing that has helped me is that I learned a lot about how to read and interpret patent literature.

 

CEOCFO: Why does Diapin Therapeutics standout?

Dr. Markham: We have a strong core competency in both cardiovascular and metabolic diseases. We understand that the diabetes therapies have had issues with cardiovascular side effects. We can interpret those results and we can also design our experiments and look for new therapies that avoid potential risks. For instance, an example of that would be that with our peptides, one of the reasons we are very excited about them is that the receptor that they stimulate has been linked to very positive effects on cardiovascular system so we anticipate that our therapy is going to differentiate itself from other therapies and will have a strong cardiovascular benefit. That is something that the endocrinologists are looking for in any new drug.

 

CEOCFO: Final thoughts?

Dr. Markham: If someone is interested, I am happy to answer any questions and I am available anytime.



 

“The target of our lead peptide is a G-protein coupled receptor that has not yet been recognized in the literature as a target for Type II diabetes treatment.” - Dr. Bruce Markham, PhD


 

Diapin Therapeutics

www.diapin.com




 

 



 

 


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