Ritter Phamaceuticals Testing New LI Compound

Ritter Phamaceuticals is the firm founded by Andrew Ritter, who has been working to try to reduce or eliminate the symptoms of lactose Intolerance (LI) since he was a high prodigy in a science fair.

Most people here will remember him from Lactagen, a prebitiotic that worked for many and was loudly missed when it went off the market. (See Lactagen No More.)

 Even before that, Ritter had started the work to test a new compound, RP-G28. (See Lactagen Prepares to File for New Drug. Whether it should be referred to as a drug is a semantic technicality that is over my head: the point to take away is that it is undergoing formal clinical testing in order to get FDA approval.)

Drug testing is a long, involved, and expensive process. Progress is being made, though. Ritter just announced through a press release that RP-G28 made it through a second successful round of tests on people.

Ritter Pharmaceuticals, Inc. today announced that Nutrition Journal has published the results of its Phase 2 trial of RP-G28, a proprietary oligosaccharide under investigation as a potential treatment for lactose intolerance. The study manuscript entitled, “Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial” is the first peer-reviewed presentation of the protocol, assessments and results which showed that RP-G28 dramatically reduced the pain and symptoms of lactose intolerant patients.

Publication of this study marks a major milestone in lactose intolerance research, as it is the first well-controlled Phase 2 study for a prescription drug candidate for patients with lactose intolerance (LI). With planning underway to begin advanced clinical trials later this year, RP-G28 may become the first approved medical therapy for LI.

“The Nutrition Journal publication validates the work that has been done by our team to provide a meaningful new therapeutic approach to managing lactose intolerance symptoms, and helping millions of lactose intolerant people worldwide,” said Andrew Ritter, president and CEO of Ritter Pharmaceuticals, Inc. “The data gleaned from this study and our extensive research into colonic adaptation as a means of treating gastrointestinal disorders are being incorporated into the design of an advanced clinical program for RP-G28,” he added.

Highlights
According to the publication’s results, a majority of the lactose intolerant patients who began the study with abdominal pain associated with dairy consumption reported no abdominal pain after taking RP-G28 and their symptom relief was sustained for at least one month thereafter, which is a statistically significant result. Likewise, the patients who received the study drug, compared to the ones who received placebo, were 6 times more likely to claim that, following treatment, they could consume dairy products free of lactose intolerance symptoms. See Nutrition Journal, December 13, 2013, Research section (http://www.nutritionj.com/content/12/1/160).

That link goes to the complete study, not just an abstract. A short article in more straightforward English can be found as a .pdf from the pages of the October 2013 FoodTechnology magazine by going to the link on this page. 

A marketable product, if it gets FDA approval, is still years away, although Ritter appears to be farther along in its testing than Lacto-Freedom. Good news about two major products, preliminary or not, is still good news.   



 

Lacto-Freedom - Sometime in the Future?

Google News allows you to customize a page for searchwords of your choice. I've been following all the articles that contain the words lactose or lactase for years. All stuff that I said here on the blog years ago - and in my books decades ago. Yawn.

Then yesterday, bam. A bolt of lightning. A possible new way of attacking the symptoms of lactose intolerance (LI). It's not here yet. You won't see it for years, even if the testing works - and in the real world testing often fails. I still had to share this with you.

His invention targets lactose intolerance was the title of a story by Jesseca DiNapoli on RecordOnline.com, the website of the Hudden Valley newspaper the Times Herald-Record of Middletown, NY. 

Ken Manzo, who started Manzo Pharmaceuticals in his Shohola home, has a longer-lasting remedy in development. It's a patented, genetically modified probiotic supplement called Lacto-Freedom. Preliminary research on Manzo's invention suggests several doses of the probiotic taken during a 24-hour period will alleviate the symptoms of the food allergy for at least three months. ...

People suffering from lactose intolerance can't digest the sugar found in dairy foods, so it ferments — bubbling into acids and gases — in the large intestine.

Fermentation causes the stomachache, said Manzo, a pharmacist at Aliton's in Port Jervis. The genetically modified probiotic in Lacto-Freedom prevents the fermentation. It stays in the walls of the intestine, properly breaking down any ingested lactose, he explained.

"A regular probiotic produces some lactase," Manzo said, referring to the enzyme that breaks down lactose. "This one is way more."

Our bodies naturally make lactase in the walls of the small intestine so this mimics the way that our digestive tract should work. It's the failure to make sufficient quantities of lactase that results in the LI symptoms we all know.

Ken Lanzo

Enough science. You want to know if this really works and when you can get your hands on it.Well, it works on rats in preliminary studies. The next stage is ... another rat study. Then maybe a human study. If he can get the funding.

Because this is 2014, he's got a campaign going on Medstartr, a medical version of Kickstarter. You can see it at Lacto-Freedom Probiotic. He needs to raise $50,000. By February 20, 2014. Yeah, that made me blink, too. I wish him luck, but...

A couple of other odd things popped up in the newspaper article. He worked with a a California biotechnology company on the first round of testing. That was back in 2006. Why the eight-year lag? Good question.

And that brings up the question of what Ritter Phamaceuticals, the maker of Lactagen, has been doing. Is Ritter the "California biotechnology company"? Probably not. I have news on that too, which I'll save for tomorrow's article.

Note to Commenters

As you can tell by the dates, I haven't been keeping up this blog. I started in 2005, had a stroke, and then had to restart it 2006, after I could use both hands again for typing. From that awkward beginning, though, it bloomed and ran 1500 posts for another six years.

That's a lot of posts on Lactose Intolerance (LI). I covered everything I could think of saying and then started repeating myself. I hate that. Blogs are wonderful fun when you're saying new stuff that people need to know - and a huge boring chore if you're running the same old stuff into the ground.

The Internet never forgets, so all those words are still available here. If you want them in more convenient form, I collected the really good, new stuff into a book, Planet Lactose: The Best of the Blog, volume 1. You can buy it as an ebook on Smashwords.com or Amazon.com or BarnesandNoble.com or a whole lot of other places that Smashwords is suppose to distribute the book to. Almost 100,000 words on LI, allergies, milk products, milk-free products, and the genetics of intolerance, along with large helpings of the weirdness that is the Net.

People still read this blog and some of your take the time to comment. Unfortunately, like everyone else online, spam is a problem so I moderate the comments and have to approve them before they appear. I've been doing that only about once a month so some of you have had long waits before your comments appear. I'm sorry about that. I'll try to do better in the future, but I won't promise anything.

One thing I need to emphasize. I read every comment and I post every comment that isn't spam. Every comment, even the insults. I wish the people who insult me because I stomped on their favorite form of quackery would refute me by citing a medical journal article or similar respectable source, but they never do. Just "It works" followed by an insult. You can judge the value of those comments for yourselves. Others provide actual useful information and I thank all of you.