Tranzyme Pharma is refocusing efforts on TZP-102, it’s diabetic gastroparesis drug treatment, after the failure of it’s flagship drug Ulimorelin.

Tranzyme Pharma & the FDA were not happy with the results of the Phase III trial results for Ulimorelin. Ulimorelin is similar to Tranzyme’s other drug TZP-102, in that it uses a ghrelin receptor agonist to stimulate motility in the gut. The drug was meant to treat people with delayed gastrointenstinal recovery / post operative ileus which is most often associated with gastrointestinal or gynecological surgery. Continue reading “Tranzyme Still Optimistic About Gastroparesis Drug Despite Stumbling Blocks” »

RedHill Biopharma is looking to start FDA & European drug trials soon for their RHB-104 MAP bacterium treatment for those with Crohn’s Disease.

The Phase II/III FDA drug trials in the US will be lead by Professor David Y. Graham from Baylor College of Medicine located in Houston, Texas. Professor Graham worked for NASA as a physician during the Apollo program, has written over 800 medical articles & is considered to be one of the “Top 50 Most Influential Gastroenterology Professionals of the 20th Century” as rated by Gastroenterology.com.

“Phase II/III” trials differ from more typical separate Phase II & Phase III trials in that the study is more randomized than a typical Phase II trial, as well as there being more participants involved. This allows data from a Phase II/III trial to be used going forward in a Phase III trial. However, Phase II/III trials require more infrastructure & patients, raising costs. Phase II/III trials could be looked at as though they are Phase III trials with stronger stop parameters than a typical Phrase III trial. Given that the drugs used within RHB-104 have gone through Phase III trials in Australia, this is probably why RedHill Biopharma is confident in moving forward with the Phase II/III style of trial. Continue reading “RedHill Biopharma’s RHB-104 MAP Treatment for Crohn’s Disease” »

Tranzyme’s TZP-102 is a Ghrelin receptor agonist designed for treatment of Gastroparesis in diabetic patients. Phase IIb trials are currently underway to further test it’s efficacy.

Ghrelin is a hormone that is generated within the walls of the stomach. It’s mainly responsible for the feeling of hunger along with helping to gear up the digestive system for food intake. Leptin is another digestive hormone that is almost the opposite of  Ghrelin in that it promotes feelings of satiety & lowers appetite. Those with Gastroparesis often have problems with loss of appetite & early feelings of fullness along with nausea & vomiting. While it’s known that usually a loss of digestive motility is the reason for these symptoms, it is not often known where the loss of motility came from. In some cases motility is not an issue, yet symptoms remain.  It is possible that those suffering from Gastroparesis may be dealing with an underproduction of Ghrelin or an overproduction of Leptin. It is also possible that these hormone levels are fine but some other issue exists like nerve or muscle damage. Regardless of the cause, increasing production of Ghrelin may be beneficial to those dealing with Gastroparesis as it may allow the digestive system to regain some lost motility while improving appetite & reducing feelings of fullness. Continue reading “Tranzyme’s TZP-102 Gastroparesis Treatment Starts Phase IIb Trials” »

Lexicon Pharmaceuticals recently announced their new drug LX1033 passed Phase I drug safety trials allowing it to move forward into Phase II testing.

Lexicon Pharmaceuticals’ LX1033 is a Irritable Bowel Syndrome drug meant for those with diarrhea predominant Irritable Bowel Syndrome symptoms or mixed symptoms that include diarrhea. LX1033 works by targeting the hydroxylase enzyme which is also known as TPH. TPH is essential for the production of serotonin within the body & it comes in two forms TPH1 & TPH2. TPH1 lives mainly in the digestive system, while TPH2 lives in the nervous system & the brain. LX1033 specifically targets TPH1 only & leaves TPH2 alone to avoid nervous system or psychoactive effects. Serotonin levels do seem to play a role in Irritable Bowel Syndrome, but how much is not fully understood. Continue reading “Lexicon Pharmaceuticals Drug LX1033 For Irritable Bowel Syndrome” »

After relatively successful Phase III trials Ironwood Pharmaceuticals’ has applied for final FDA approval of their flagship drug, Linaclotide, which is for the treatment of constipation & pain related Irritable Bowel Syndrome symptoms.

Continue reading “Ironwood Pharmaceuticals’ Linaclotide IBS Drug Looking For Final FDA Approval” »

BioLineRx announced that it has licensed an experimental immunotherapy drug from Yissum Research Development Company Ltd which is the business side of Hebrew University of Jerusalem(Israel).

The drug is currently known as “BL-7040” & BioLineRx has plans to further develop & commercialize the drug worldwide. BL-7040 is an experimental drug that is still in testing, but it has already passed Phase Ib & Phase IIa clinical trials. Officially it won’t be known how well BL-7040 works until it’s subjected to Phase IIb clinical trials. However, Prof. Hermona Soreq sounds optimistic on the drug’s efficacy:

The efficacy of BL-7040 in these [earlier] studies was shown to be highly significant and comparable to that of dexamethasone, a steroid used routinely for IBD that has multiple side effects. Continue reading “BioLineRX’s TLR-9 Immunotherapy For Inflammatory Bowel Disease” »

Advanced techniques in stem cell therapy may lead to new treatment options for those with Inflammatory Bowel Diseases.

MultiStem is a stem cell treatment therapy currently in development by Athersys in partnership with Pfzier. Athersys is currently targeting MultiStem as a treatment for a variety of illnesses such as Inflammatory Bowel Disease but also things like recovery from stroke, heart problems & transplant rejection. Multistem starts by harvesting stem cells from the bone marrow of a donor. Due to the technique that Athersys uses the donor does not have to be a tissue match for the recipient like in some other stem cell treatments. Supposedly it is also easy to mass produce MultiStem as a single donor can produce hundreds of thousands or even millions of doses. Continue reading “Novel Stem Cell Treatments For Inflammatory Bowel Disease” »

Nexvax2 may become a breakthrough for preventing or treating Celiac disease.

The company ImmusanT has released information that their Celiac Disease vaccine “Nexvax2” passed their three week Phase I clinical trial. Phase I trials only test safety, tolerability & bioactivity in humans & are not meant to test how effective the drug or vaccine is. Some patients receiving the vaccine experienced symptoms similar to what they would experience from gluten exposure, which was expected. Continue reading “Celiac Vaccine Showing Promise” »

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