Ritter Pharmaceuticals: RP-G28 and Lactose Intolerance [transcript] [audio]

Guest: Andrew Ritter

Presenter: Neal Howard

Guest Bio: Mr. Ritter co-founded Ritter Pharmaceuticals, Inc., upon his own personal affliction with lactose intolerance. He spearheaded the development of the company’s lead compound, RP-G28, which has the potential to become the first FDA-approved treatment for lactose intolerance. The therapeutic is currently in Phase 3 clinical trials. The company was originally launched out of Ritter Naturals Sciences, a direct-to-consumer healthcare marketing company, founded by Mr. Ritter in 2004, which developed and commercialized digestive healthcare products: Lactagen®, Health Essentials™ and Better Digestion™. Mr. Ritter holds over a dozen patents with over twenty additional patents pending in the United States and other key international markets. In addition, Mr. Ritter has co-published articles in the Proceedings of the National Academy of Sciences, Nutrition Journal, Food Technology, among others.

Segment Overview: Andrew Ritter, co-founder and president of Ritter Pharmaceuticals discusses the company history and the recent report on the RP-G28 phase 2b study that shows data that promotes beneficial adaptation of the gut microbiome. He also talks about the difficulties of living with moderate to severe lactose intolerance, and the significance of a potential FDA-approved treatment.

Transcript

Neal Howard: Welcome to the program. I’m your host Neal Howard here on Health Professional Radio. Glad that you could join us today for a conversation with Mr. Andrew Ritter. He’s Co-Founder and President of Ritter Pharmaceuticals. He’s joining us on the program to talk about the company, Ritter Pharmaceuticals, give us a little bit of history and also talk about a recent report on the RP-G28 phase 2B study that talks about the beneficial adaptation of the gut microbiome. Welcome to the program Andrew. How are you?

Andrew Ritter: Thank you for having me today.

N: Give our listeners just a bit of background about yourself and then we’ll jump right in.

R: Sure. I’m the President and Co-Founder of Ritter Pharmaceuticals. We’re a drug development company focusing and developing the first FDA approved treatment for lactose intolerance. It’s a condition that I actually personally grew up severely suffering from. As a young child I used to severely suffer from lactose intolerance from which if I had any dairy products, I’d have severe gastrointestinal symptoms of gas, cramps, bloating, whenever I had dairy products. So after years of suffering, I decided to contact leading lactose intolerance and GI experts around the country to develop a better treatment and this company started based on those efforts.

N: What were the treatments that you were familiar with before you went on your efforts to develop your own successful treatment?

R: There are treatments currently available to manage lactose intolerance. You can avoid dairy products which is easier to do at home but when you’re in restaurants, it’s really hard to avoid hidden dairy foods such as having cream in a soup or in a salad dressing. You can take lactose free foods such as Lactaid milk or soy milk or you can take pills called Lactaid pills that you can take before your meal or if you have a hidden dairy product, you don’t take the pill before the food, you’ll get sick. The current options are really limiting for patients suffering from lactose intolerance. There’s over 40 million Americans that suffer from lactose intolerance today and over a billion people worldwide that suffer from lactose intolerance. There’s a very high prevalence to lactose intolerance in Europe as well in Asia. These treatment options aren’t real treatment for those that suffer.

N: Is Ritter Pharmaceuticals exclusively involved in lactose intolerance?

R: Our primary focus today is in lactose intolerance as we’re moving into our phase 3 clinical program in developing this product for lactose intolerance in the US, seeking FDA approval for the product which we then hope to bring the product globally. Beyond lactose intolerance, we see great potential for our asset in other indications. We plan in the near future to start further exploring those additional indications.

N: You spoke about working toward an FDA approval. You’re already in phase 2B of this study.

R: We recently completed a phase 2B clinical study which is a very large study, 377 subject study in lactose intolerance, multi-center studied up in 15 Centers, it was actually one of the largest clinical phase ever conducted in lactose intolerance. Can you believe that?

N: Wow. Amazing.

R: In this study, we explored patients and evaluated their symptoms of lactose intolerance and have found that a large number of patients dramatically reduced the symptoms in a meaningful way post treatment compared to before the treatment. Further, we found that those patients on the treatment were consuming more milk and dairy products after taking RP-G28 as well post treatment. We backed up and said our product RP-G28 is a one course treatment. So you take the product once for 30 days, for 30 consecutive days and after that you can then tolerate milk products, symptom free. If you just take one time treatment for lactose intolerance, so you can have ice cream, pizza, you can have dairy foods again without having dramatic symptoms when you consume these foods.

N: What are the some of the side effects if any of taking this product for 30 days straight and then being able to tolerate dairy products. Would you say, indefinitely or for a limited amount of time, 6 months, a year, 2 weeks?

R: The safety profile for this compound so far has been very, very strong. In two clinical studies now we’ve seen very little to no adverse events. The drug versus placebo perform very similarly when it came to the safety profile. There’s no major safety concerns that we’ve seen thus far. The product itself from a durability standpoint is of lasting long term, we have evaluated first and foremost to our mechanism of action which is something we explained as colonic adaptation. So how the products works, is you take the product and it stimulates growth of lactose-metabolizing bacteria in the colon. The healthy bacteria in the colon, stimulates needs growth from, and when you consume dairy products, these bacteria help break down the dairy. We believed the durable experience because as you consume dairy products, the dairy you consume continues to use these bugs to thrive. And so all things equal, you maintain these bugs as you consume dairy products. However, we believe if you have something what we would call a gut disruption or you take antibiotics or you avoid dairy products for a long period of time, you may need a re-treatment. We detect some patients periodically may need to take the re-treatment which is just taking the product again.

N: So we’re not talking about a one time treatment and then being able to deal with dairy on an actually normal basis. You still have to maintain some dairy in order to maintain the bacteria in the gut. And as you say, for a long period of time, say you decide to not do any dairy for 6 months, is that considered a long period of time or are we talking you don’t do any dairy for a couple of weeks after this treatment and then you have to take the treatment again?

R: You need to really avoid dairy for a long period of time. It is an expectation but it’s not going to be that much of an issue. In our phase 3 program coming up which we expect to launch coming up here in the 2nd quarter of the year, we are exploring durability of treatment in a lot greater fashion, we’re going to look at patients and seeing that they can maintain tolerance over a greater period of time as well as exploring how much milk and dairy products they’re consuming during those periods.

N: Are we talking any type of dairy products or certain dairy products that are manufactured or treated in certain ways, say milk or cheese, things to that nature. Are there certain ways that they can be treated and still be considered dairy but not be harmful?

R: Every individual has lactose intolerance but it differs in severity levels and has harder forms or easier types of different foods. It’s really a person to person experience, as of the level but what we’ve found is our program no matter if you have minor symptoms to severe symptoms, we show that the product helps reduce their symptoms and allows them to consume dairy products again without worrying about those GI symptoms.

N: In wrapping up, one last question. When it comes to the benefits of this product, does it matter what the age of the consumer may be? Did you test younger children, adolescents, young adults as well as more mature patients in this extensive study?

R: Our current studies have been in adults only. We expect to look at younger ages as we move forward in our clinical program.

N: Where can we go and learn some more about the Ritter Pharmaceuticals and about this brand new product that is soon to be the FDA approved?

R: You can hear more about our company at ritterpharma.com. We provide all our latest information and further details about the company on our website.

N: Thanks for giving us this insight today and hoping that you’ll give us some updates as the phase 3 studies come out and the FDA approval is just around the corner I would suspect, yes?

R: Thank you very much for having me on today.

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