Ritter Pharmaceuticals: RP-G28 and Lactose Intolerance

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? Thank you for having me today. Give our listeners just a bit of background
about yourself and then we’ll jump right in. 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. What were the treatments that you were familiar
with before you went on your efforts to develop your own successful treatment? There are treatments currently available to
manage lactose intolerance. You can avoid dairy products which are 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 of lactose
intolerance in Europe as well in Asia. These treatment options aren’t real treatment
for those that suffer. Is Ritter Pharmaceuticals exclusively involved
in lactose intolerance? 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. You spoke about working toward an FDA approval. You’re already in phase 2B of this study. We recently completed a phase 2B clinical
study which is a very large study, 377 subject studies 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? Wow. Amazing. 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. 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? 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 are 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 a colonic adaptation. So how the products works, is you take the
product and it stimulates the 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
that 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. 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? 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. 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 of that nature. Are there certain ways that they can be treated
and still be considered dairy but not be harmful? 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. 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? Our current studies have been in adults only. We expect to look at younger ages as we move
forward in our clinical program. 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? 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. 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? Thank you very much for having me on today. You’ve been listening to Health Professional
Radio. Transcripts and audio of the program are available
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