Ritter Pharmaceuticals RP-G28 Increases Intestinal Microbiota to Treat Lactose Tolerance
March 14, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On March 12, Ritter, a US pharmaceutical company that developed innovative treatments for gastrointestinal diseases by regulating intestinal microbiota, announced that it was mainly in the Phase 2b study of 377 patients with lactose intolerance in the study of drug RP-G28. Promotes the beneficial adaptation of the intestinal microbiota. The drug is also a key development project of the company and is expected to be the first lactose intolerance treatment approved by the FDA.
Dr. Andrea Azcarate-Peril, associate professor of medicine at the University of North Carolina at Chapel Hill, said in a report that RP-G28 can modify the relative abundance of 28 bacteria. Specifically, a dramatic increase in Bifidobacterium has been observed, including some known bacteria that metabolize lactose. The mechanism by which RP-G28 alleviates the symptoms of lactose intolerance is to compensate for the deficiency of endogenous lactase activity by increasing the lactose metabolism bacteria in the colon. These beneficial bacteria remove undigested lactose from the intestines, thereby reducing the amount of gas produced and the retention of water leading to symptoms of lactose intolerance.
Azcarate-Peril commented: "These findings are consistent with the clinical phase 2a trial of RP-G28 for lactose intolerance. In the Phase 2a study, we observed an increase in the number of bifidobacteria in this larger clinical 2b study. This has been confirmed. This phenomenon is important because bifidobacteria have proven to be very beneficial to the gastrointestinal tract and the immune system."
The microbiota data for this study mainly includes the following:
1. After receiving RP-G28 treatment, the microbial population was beneficially adapted and had a significant effect on the abundance of 28 bacteria.
2. High-throughput quantitative polymerase chain reaction (qPCR) data showed relative abundance of Actinobacillus, Bifidobacteria, Bifidobacterium and Lactobacillus after 30 days of treatment in two RP-G28 treatment groups There was a significant increase, and this was not observed in the placebo group. More specifically, the abundances of angulatum, B. gallicum, B. longum, B. bifidum, B. breve, and B. catenulatum were also elevated after RP-G28 treatment.
3. Bifidobacterium actinomycetes have a higher proportion of patients in the treatment group. The proportion of bifidobacteria in the treatment group was 77.7% (77/99), and that in the placebo group was 52.1% (49/94) (p=<0.001), similar to the trend reflected in the clinical 2a test data.
4. The contents of Pediococcus, Enterococcus and Delft were significantly increased on the 30th day after low dose and high dose treatment.
Andrew J. Ritter, co-founder and president of Ritter Pharmaceuticals, added: "These results confirm the effective mode of action of RP-G28 and further support the potential of this therapy in other indications. With the treatment of lactose with RP-G28 The Tolerance Study will advance to the Phase 3 trial in the second quarter of 2018, and we will examine how these findings have a positive impact on other lactose intolerance patients." (Sina Medical Compilation/David)
Article Reference Source: Ritter Pharmaceuticals Reports Microbiome Data from Phase 2b Study of RP-G28 Promotes Beneficial Adaptation of the Gut Microbiome
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