Aldafermin for Irritable Bowel Syndrome

"Taking into account the Phase 2 status of this drug, our team at Power assigned Aldafermin a safety rating of two since there is some data confirming its security but no clinical evidence to support efficacy."

"According to the trial sponsor, NGM Biopharmaceuticals, Inc., primary outcomes are Change in fasting serum C4 levels from baseline as measured by a validated laboratory assay and will be quantified over 28 days. Additionally, secondary metrics such as Average daily stool consistency score (which is based on Bristol Stool Form Scale), Maximum abdominal pain score, and Number of bowel movements per week will also be evaluated."

"This medical research is recruiting 30 individuals, aged 18 to 75 years old and suffering from functional diarrhea or IBS with diarrhoea based on Rome III or IV criteria. Other requirements include C4 serum levels above 52 ng/mL, fecal BA of more than 2,337 μmoles / 48 hours, total fecal BA greater than 1,000 μmoles / 48 hours plus 4% primary BA, body mass index between 18.0-45.0 kg/m2 as well as an understanding and willingness to comply with the study's procedures; tricyclic antidepressants (TCAs), selective serotonin reuptake"

"Indeed, clinicaltrials.gov records confirm that recruitment for this medical experiment is ongoing and has been since December 1st 2021. The most recent update to the trial was made on April 20th 2022; 30 participants are needed at a single site."

"This study is open to those over 18 years old but under 75, providing they meet the necessary criteria."

"Affirmative. Clinicaltrials.gov data indicates that this ongoing research is currently accepting volunteers; it was uploaded on December 1st 2021 and last updated April 20th 2022, with a requirement for 30 participants from one centre."

"Currently, there are two active Aldafermin trials with none in the third phase. Rochester is a central location for these studies but 72 other sites are also conducting experiments related to this drug."

"Since 2020, Aldafermin has been the subject of multiple clinical trials. NGM Biopharmaceuticals, Inc was responsible for initiating its research in that year with an initial cohort size of 160 participants. After successful Phase 2 results were obtained, two active studies are currently being conducted across 10 nations and 46 cities."