RP‐G28’s Potential for FDA Approval to Treat Lactose Intolerance [Interview][Transcript]

andrew_ritter_ritter_pharmaceuticalsGuest: Andrew Ritter
Presenter: Neal Howard
Guest Bio: Andrew Ritter’s story is that of a biotechnology founder with an impassioned and unique drug discovery story that involves testing drug candidates on himself at an early age and Andrew has now been free of any lactose issues for 17 years. He actually began drug discovery research in middle school.

Segment overview: In this Health Supplier Segment, Andrew Ritter of LA-based Ritter Pharmaceuticals, discusses how the company just completed enrollment of their RP-G28 in Phase 2b/3 trials and hopes to have results later this year.

Health Professional Radio – Lactose Intolerance

Neal Howard: Hello and welcome to Health Professional Radio, I’m your host here on this Health Suppliers Segment, welcome to the program. Our guest in studio is Andrew Ritter of LA based Ritter Pharmaceuticals and he’s here with us to discuss how the company just completed enrollment of their RPG 28 and phase 2B/3 trials, also to talk about the lack of an FDA approved treatment for lactose intolerance. Welcome to the program Andrew.

Andrew Ritter:    Thank you for having me.

N:   Thank you. You’re the founder of Ritter Pharmaceuticals in Los Angeles, talk about when and why you founded Ritter Pharmaceuticals.

A:    So Ritter Pharmaceuticals is a company focusing on developing digestive treatments that treat all hosts of digestive health conditions. Our primary focus is currently on lactose intolerance, which RPG 28 our lead compound, stands to hopefully become potentially the first prescription drug to treat this condition. Lactose intolerance is affecting 40 million of Americans and over 9 million have mild to severe symptoms from this condition.

N:   What are the treatments traditionally then for lactose intolerance?

A:    So for lactose intolerance which is a challenging condition, not only are the symptoms often very painful, but they also can be very embarrassing. Symptoms include gas, cramps, bloating, and diarrhea and the consumption of dairy products such as milk, ice cream, pizza, and cheese. And when you’re lactose intolerant, you have to avoid these foods. Currently, there’s no real reliable or effective treatment available. One can avoid their products, or they can take lactase supplement pills you take every soon time you have … They always have to carry these pills around and they don’t always work. Our product has become a better treatment option for these patients, in which you take the product for 30 days, and after taking it for 30 days, you can then tolerate dairy products again with reduced symptoms or no symptoms at all.

N:   After you take up to 30 days, is this something that’s a permanent fix or are you on a 30-day regimen say, every month, or every two months, or something like that?

A:    Try it for acute treatment where you take it for just 30 days, and then afterwards, you can tolerate dairy products freely, wherein the process of devaluing the ability of the treatment, but what we found is these patients maintain tolerance long-term afterwards. How the product works is that it … adapts the colon’s bacteria, lactose metabolizing bacteria increase in quantity in BO2 digest the lactose consumed in dairy products. And our belief in our standing based on our research shows that this bacteria, thrive in the colon as you consumed dairy products. The dairy consumes …to grow and maintain, and based on that you have a durable treatment to your symptoms of lactose intolerance.

N:   Now how many people were involved in your trials?

A:    Our clinical state currently underway is a Phase 2B/3 clinical study, it includes 377 subjects. We just recently, about 10 days ago now that we had a last patient visit in that program so all patients have come to the program. And we expect to have data readout in the first quarter of 2017.

N:   As far as age and gender, are you testing across the board or did your test subjects have a specific age or gender that was involved?

A:    So there’s no gender restriction to the study and with a wide range of each included subjects.

N:   Any significant side-effects from using this drug?

A:    Well we don’t have the data yet from this day to the clinical study, but I can tell you in our first study, we conducted a phase 2A study in 62 subjects where we reported no assays or no significant adverse event in that study. Our product has been shown to be very safe and partially, our safety profile for this product has a long history of safety. Because our starting material for this product comes from generally guarded safe…or grass component, so it’s found to be very safe and in fact when we submitted our IMD to the FDA, we were able to bypass traditional phase 1 clinical studies and moved directly into our phase 2 program based on our safety profile we were able to show.

N:   Okay, great. Now, is this the first time biotech company that you have founded? Ritter Pharmaceuticals or is your history pretty much based in biotech founding of other companies as well?

A:    So I founded Ritter Pharmaceuticals based upon my personal affliction with lactose intolerance. I grew up severely lactose intolerant as a young child and doctors tell me there is nothing I could do but avoid dairy products. So after years of suffering, I decided to contact leading lactose intolerance and GI experts from around the country to develop a better treatment. In that way, the founding of this company, I founded the company in 2004 to pursue a treatment for lactose intolerance. It’s led us to today to being one of leading researchers in this field as well as one of pioneers in the microbiome space, as a lot of our science is based off of exploring the microbiome and how that may help improve digestive health.

N:    Do your products ever treat other GI symptoms as well, maybe an added benefit of your product? Is that something that you have seen or is that something that we’re still waiting on results from the trials?

A:    So we see great potential on our products to potentially help, maybe later to treat other diseases, if by looking at the gut microbiome. We are looking to explore a variety of diseases in a metabolic gastrointestinal in … liver disease areas. We currently are designing pre-clinical development efforts in conjunctional creating partnerships with various universities to explore these additional diseases.

N:    And where can our listeners go on and get more information about your research and Ritter Pharmaceuticals?

A:    Our information can be found on a website at ritterpharma.com, that’s R-i-t-t-e-r-p-h-a-r-m-a.com.

N:    Well it’s been a pleasure talking with you today Andrew.

A:    Thank you very much for your time, I appreciate you having me on today.

N:    Thank you. You’ve been listening in the Health Professional Radio, this Health Supplier Segment with Andrew Ritter of Ritter Pharmaceuticals, he’s been here discussing lactose intolerance, the lack of an FDA approved treatment for lactose intolerance and how their product RPG28 is looking extremely promising as a treatment, as an effective treatment for lactose intolerance. Transcripts and audio of this program are available at healthprofessionalradio.com.au and also at hpr.fm and you can subscribe to this podcast on iTunes.

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